Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.
Interventions
DRUGliraglutide
Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
DRUGplacebo
Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Confirmed diagnosis of PWS (Prader-Willi Syndrome) (by genetic testing) * Male or female, age at the time of signing informed consent: - Part A: above or equal to 12 years and less than 18 years * Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B * BMI (body mass index) corresponding to equal or above 30 kg/m\^2 for adults by international cut-off points1 and equal or above the 95th percentile for age and sex (for diagnosis of obesity) * Stable body weight during the previous 90 days before screening ( below 10 kg self-reported weight change) * Testing has been performed to evaluate for adrenal insufficiency and documented in medical record
Exclusion criteria
* Type 1 diabetes mellitus (T1DM) * Type 2 diabetes mellitus (T2DM) * Calcitonin equal or above 50 ng/L * No change in treatment plan with growth hormone (GH) from randomisation to the end of the open-label period patients on growth hormone to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted) * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC) * History of pancreatitis (acute or chronic) * Treatment with any medication prescribed for weight loss within 90 days before screening (e.g. orlistat, zonisamide, topiramate/phentermine, lorcaserin, phentermine, bupropion/naltrexone,liraglutide, metformin) * Untreated adrenal insufficiency * Suggestive history of, or significant risk of gastroparesis (e.g. marked abdominal bloating post meal, history of vomiting, severe constipation), as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | Week 0, Week 16 | Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial. |
| Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | Week 0, Week 52 | Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | At week 16 | Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16. |
| Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | At week 52 | Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52. |
| Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | At week 16 | Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16. |
| Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | At week 52 | Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52. |
| Percentage of Participants With no Increase in BMI SDS at Week 16 | At week 16 | Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16. |
| Percentage of Participants With no Increase in BMI SDS at Week 52 | At week 52 | Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52. |
| Change in BMI From Baseline at Week 16 | Week 0, week 16 | Change in body mass index (BMI) from baseline to week 16 is presented. |
| Change in BMI From Baseline at Week 52 | Week 0, week 52 | Change in body mass index (BMI) from baseline to week 52 is presented. |
| Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | Week 0, week 16 | Change in body weight (kg) from baseline to week 16 is presented. |
| Change in Body Weight (kg) From Baseline at Week 52 | Week 0, week 52 | Change in body weight (kg) from baseline to week 52 is presented. |
| Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | Week 0, week 16 | Change in body weight (lb) from baseline to week 16 is presented. |
| Change in Body Weight (lb) From Baseline at Week 52 | Week 0, week 52 | Change in body weight (lb) from baseline to week 52 is presented. |
| Change in Body Weight (Percentage [%]) From Baseline at Week 16 | Week 0, week 16 | Change in body weight (%) from baseline to week 16 is presented. |
| Change in Body Weight (%) From Baseline at Week 52 | Week 0, week 52 | Change in body weight (%) from baseline to week 52 is presented. |
| Change in Waist Circumference From Baseline at Week 16 | Week 0, week 16 | Change in waist circumference from baseline to week 16 is presented. |
| Change in Waist Circumference From Baseline at Week 52 | Week 0, week 52 | Change in waist circumference from baseline to week 52 is presented. |
| Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Week 0, week 16 | Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity. |
| Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Week 0, week 52 | Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity. |
| Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | Week 0, week 16 | Change in hsCRP from baseline to week 16 is presented. |
| Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | Week 0, week 52 | Change in hsCRP from baseline to week 52 is presented. |
| Change in Total Cholesterol From Baseline at Week 16 | Week 0, week 16 | Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in Total Cholesterol From Baseline at Week 52 | Week 0, week 52 | Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | Week 0, week 16 | Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | Week 0, week 52 | Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | Week 0, week 16 | Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | Week 0, week 52 | Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | Week 0, week 16 | Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | Week 0, week 52 | Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | Week 0, week 16 | Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | Week 0, week 52 | Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in Triglycerides From Baseline at Week 16 | Week 0, week 16 | Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in Triglycerides From Baseline at Week 52 | Week 0, week 52 | Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | Week 0, week 16 | Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline. |
| Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | Week 0, week 52 | Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline. |
| Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | Week 0, week 16 | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented. |
| Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | Week 0, week 52 | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented. |
| Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | Week 0, week 16 | Change in HbA1c from baseline to week 16 is presented. |
| Change in HbA1c From Baseline at Week 52 | Week 0, week 52 | Change in HbA1c from baseline to week 52 is presented. |
| Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | Week 0, week 16 | Change in FPG from baseline to week 16 is presented. |
| Change in FPG From Baseline at Week 52 | Week 0, week 52 | Change in FPG from baseline to week 52 is presented. |
| Change in Fasting Insulin From Baseline at Week 16 | Week 0, week 16 | Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline. |
| Change in Fasting Insulin From Baseline at Week 52 | Week 0, week 52 | Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline. |
| Change in Fasting C Peptide From Baseline at Week 16 | Week 0, week 16 | Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline. |
| Change in Fasting C Peptide From Baseline at Week 52 | Week 0, week 52 | Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline. |
| Number of Participants in Glycaemic Category at Week 16 | week 16 | Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG \<5.6 mmol/L (\<100 mg/dL) and/or HbA1c \<5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. |
| Number of Participants in Glycaemic Category at Week 52 | Week 52 | Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG \<5.6 mmol/L (\<100 mg/dL) and/or HbA1c \<5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. |
| Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | Week 0, week 16 | Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin\[mU/L\]/(FPG\[mmol/L\]-3.5). |
| Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | Week 0, week 52 | Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin\[mU/L\]/(FPG\[mmol/L\]-3.5). |
| Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | Week 0, week 16 | Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose \[mmol/L\] x fasting insulin \[mmol/L\]/ 22.5. |
| Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | Week 0, week 52 | Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose \[mmol/L\] x fasting insulin \[mmol/L\]/ 22.5. |
| Number of Treatment Emergent Adverse Events | From week 0 to week 54 | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)). |
| Number of Severe Treatment Emergent Episodes of Hypoglycaemia | From week 0 to week 54 | Hypoglycaemic episode (blood glucose less than or equal to (\<=) 3.9 mmol/L (70 mg/dL) Or greater than (\>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54). |
| Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | Week 0, week 16 | Change in CEA serum from baseline to week 16 is presented. |
| Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | Week 0, week 52 | Change in CEA serum from baseline to week 52 is presented. |
| Change in Hormone Level: Calcitonin From Baseline at Week 16 | Week 0, week 16 | Change in calcitonin from baseline to week 16 is presented. |
| Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | From week 0 to week 54 | Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value \< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54). |
| Number of Participants With Occurrence of Anti-liraglutide Antibodies | From week 0 to week 54 | Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies. |
| Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0, Week 16 | A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented. |
| Number of Participants With Change in ECG From Baseline at Week 52 | Week 0, Week 52 | A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented. |
| Change in Pulse From Baseline at Week 16 | Week 0, week 16 | Change in pulse from baseline to week 16 is presented. |
| Change in Pulse From Baseline at Week 52 | Week 0, week 52 | Change in pulse from baseline to week 52 is presented. |
| Change in Haematology: Haemoglobin From Baseline at Week 16 | Week 0, week 16 | Change in haemoglobin from baseline to week 16 is presented. |
| Change in Haematology: Haemoglobin From Baseline at Week 52 | Week 0, week 52 | Change in haemoglobin from baseline to week 52 is presented. |
| Change in Haematology: Haematocrit From Baseline at Week 16 | Week 0, week 16 | Change in haematocrit from baseline to week 16 is presented. |
| Change in Haematology: Haematocrit From Baseline at Week 52 | Week 0, week 52 | Change in haematocrit from baseline to week 52 is presented. |
| Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Week 0, week 16 | Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented. |
| Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Week 0, week 52 | Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented. |
| Change in Haematology: Erythrocytes From Baseline at Week 16 | Week 0, week 16 | Change in erythrocytes from baseline to week 16 is presented. |
| Change in Haematology: Erythrocytes From Baseline at Week 52 | Week 0, week 52 | Change in erythrocytes from baseline to week 52 is presented. |
| Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Week 0, week 16 | Change in creatinine and bilirubin (total) from baseline to week 16 is presented. |
| Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Week 0, week 52 | Change in creatinine and bilirubin (total) from baseline to week 52 is presented. |
| Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Week 0, week 16 | Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented. |
| Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Week 0, week 52 | Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented. |
| Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Week 0, week 16 | Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented. |
| Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Week 0, week 52 | Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented. |
| Change in Biochemistry: Albumin From Baseline at Week 16 | Week 0, week 16 | Change in albumin from baseline to week 16 is presented. |
| Change in Biochemistry: Albumin From Baseline at Week 52 | Week 0, week 52 | Change in albumin from baseline to week 52 is presented. |
| Change in Hormone Level: Calcitonin From Baseline at Week 52 | Week 0, week 52 | Change in calcitonin from baseline to week 52 is presented. |
| Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Week 0, week 16 | Change in TSH and prolactin from baseline to week 16 is presented. |
| Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Week 0, week 52 | Change in TSH and prolactin from baseline to week 52 is presented. |
| Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | Week 0, week 16 | Change in free T4 and ACTH from baseline to week 16 is presented. |
| Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | Week 0, week 52 | Change in free T4 and ACTH from baseline to week 52 is presented. |
| Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Week 0, week 16 | Change in IGF-1 and cortisol from baseline to week 16 is presented. |
| Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Week 0, week 52 | Change in IGF-1 and cortisol from baseline to week 52 is presented. |
| Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | Week 0, week 16 | Change in DHEAS from baseline to week 16 is presented. |
| Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | Week 0, week 52 | Change in DHEAS from baseline to week 52 is presented. |
| Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | Week 0, week 16 | Change in LH and FSH from baseline to week 16 is presented. |
| Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | Week 0, week 52 | Change in LH and FSH from baseline to week 52 is presented. |
| Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | Week 0, week 16 | Change in estradiol (only for females) from baseline to week 16 is presented. |
| Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | Week 0, week 52 | Change in estradiol (only for females) from baseline to week 52 is presented. |
| Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | Week 0, week 16 | Change in waist-to-hip circumference ratio from baseline to week 16 is presented. |
| Change in Hormone Level: Testosterone (Males) From Baseline at Week 52 | Week 0, week 52 | Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial. |
| Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0, week 16 | This outcome measure presents pubertal status results which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult. |
| Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0, week 52 | This outcome measure presents pubertal status results which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult. |
| Number of Participants With Change in Physical Examination From Baseline at Week 16 | Week 0, week 16 | This outcome measure presents number of participants with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation. |
| Number of Participants With Change in Physical Examination From Baseline at Week 52 | Week 0, week 52 | This outcome measure presents number of participants with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation. |
| Height Velocity at Week 16 | Week 16 | Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented. |
| Height Velocity at Week 52 | week 52 | Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented. |
| Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 0, week 16 | C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is yes for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is yes for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with suicidal ideation or suicidal behaviour on C-SSRS assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B. |
| Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 0, week 52 | C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is yes for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is yes for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with suicidal ideation or suicidal behaviour on C-SSRS assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B. |
| Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16 | Week 0, week 16 | Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B. |
| Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52 | Week 0, week 52 | Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B. |
| Change in Hormone Level: Testosterone (Males) From Baseline at Week 16 | Week 0, week 16 | Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial. |
| Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | Week 0, week 52 | Change in waist-to-hip circumference ratio from baseline to week 52 is presented. |
Countries
Australia, Canada, France, Italy, Netherlands, New Zealand, Turkey (Türkiye), United States
Participant flow
Recruitment details
The trial was conducted at 20 sites in 8 countries as follows: Australia (2), Canada (1), France (7), Italy (2), Netherlands (1), New Zealand (1), Turkey (3), and the United States (3).
Pre-assignment details
Trial has part A & B, participants entered sequentially into part A & B, and were randomised 2:1 (liraglutide/placebo). Part A conducted in adolescents (≥12-\<18 years \[yrs\], Tanner stage 2-5) with Prader-Willi Syndrome (PWS) and obesity; Part B in children (≥6-˂12 yrs, Tanner stage below 2 with PWS and obesity. On part A 16-week double-blind period completion, data monitoring committee reviewed PK data to un-blind part A safety data then recommended randomisation (liraglutide/placebo) in part B.
Participants by arm
| Arm | Count |
|---|---|
| Part A: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. Dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a maximum tolerated dose (MTD) (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). | 19 |
| Part A: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks. | 12 |
| Part B: Liraglutide Participants received once daily subcutaneous injection of liraglutide for 52 weeks. For children with body weight ≥ 45 kg; dosing was initiated with liraglutide 0.6 mg daily for one week and increased in weekly dosage steps of 0.6 mg until a MTD (as judged by the Investigator) or a dose of 3.0 mg liraglutide was reached, i.e., 0.6 mg (week 1), 1.2 mg (week 2), 1.8 mg (week 3), 2.4 mg (week 4) and 3.0 mg (week 5 to week 52). For children with body weight \<45 kg: dosing was initiated with liraglutide 0.3 mg daily for one week and increased to 0.6 mg after the first week. Thereafter, the dose was increased in weekly steps of 0.6 mg until an MTD (as judged by the Investigator) or a dose of 2.4 mg liraglutide was reached. i.e., 0.3 mg (week 1), 0.6 mg (week 2), 1.2 mg (week 3), 1.8 mg (week 4), 2.4 mg (week 5 to week 52). | 17 |
| Part B: Placebo Participants received once daily subcutaneous injection of placebo matched to liraglutide for 16 weeks. | 7 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Unclassified | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Part A: Liraglutide | Part A: Placebo | Part B: Liraglutide | Part B: Placebo |
|---|---|---|---|---|---|
| Age, Customized 12 - <18 years | 31 Participants | 19 Participants | 12 Participants | 0 Participants | 0 Participants |
| Age, Customized 6 - <12 years | 24 Participants | 0 Participants | 0 Participants | 17 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 18 Participants | 12 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 6 Participants | 6 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 11 Participants | 6 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Female | 28 Participants | 10 Participants | 5 Participants | 11 Participants | 2 Participants |
| Sex: Female, Male Male | 27 Participants | 9 Participants | 7 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 | 0 / 12 | 0 / 7 |
| other Total, other adverse events | 16 / 20 | 17 / 17 | 10 / 12 | 4 / 7 |
| serious Total, serious adverse events | 1 / 20 | 2 / 17 | 0 / 12 | 1 / 7 |
Outcome results
Primary
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks
Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
Time frame: Week 0, Week 16
Population: Full analysis set (FAS) which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | -0.18 SDS score | Standard Deviation 0.21 |
| Part A: Placebo | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | -0.18 SDS score | Standard Deviation 0.23 |
| Part B: Liraglutide | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | -0.50 SDS score | Standard Deviation 0.65 |
| Part B: Placebo | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | -0.48 SDS score | Standard Deviation 0.39 |
| Part A+B: Liraglutide | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | -0.33 SDS score | Standard Deviation 0.49 |
| Part A+B: Placebo | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 Weeks | -0.29 SDS score | Standard Deviation 0.32 |
Primary
Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks
Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
Time frame: Week 0, Week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | -0.27 SDS score | Standard Deviation 0.37 |
| Part A: Placebo | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | -0.13 SDS score | Standard Deviation 0.25 |
| Part B: Liraglutide | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | -0.79 SDS score | Standard Deviation 1.21 |
| Part B: Placebo | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | -0.71 SDS score | Standard Deviation 0.68 |
| Part A+B: Liraglutide | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | -0.50 SDS score | Standard Deviation 0.88 |
| Part A+B: Placebo | Change in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 Weeks | -0.36 SDS score | Standard Deviation 0.53 |
Secondary
Change in Biochemistry: Albumin From Baseline at Week 16
Change in albumin from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Albumin From Baseline at Week 16 | 0 gram per deciliter (g/dL) | Standard Deviation 0.2 |
| Part A: Placebo | Change in Biochemistry: Albumin From Baseline at Week 16 | 0 gram per deciliter (g/dL) | Standard Deviation 0.1 |
| Part B: Liraglutide | Change in Biochemistry: Albumin From Baseline at Week 16 | 0 gram per deciliter (g/dL) | Standard Deviation 0.2 |
| Part B: Placebo | Change in Biochemistry: Albumin From Baseline at Week 16 | 0 gram per deciliter (g/dL) | Standard Deviation 0.1 |
| Part A+B: Liraglutide | Change in Biochemistry: Albumin From Baseline at Week 16 | 0 gram per deciliter (g/dL) | Standard Deviation 0.2 |
| Part A+B: Placebo | Change in Biochemistry: Albumin From Baseline at Week 16 | 0 gram per deciliter (g/dL) | Standard Deviation 0.1 |
Secondary
Change in Biochemistry: Albumin From Baseline at Week 52
Change in albumin from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Albumin From Baseline at Week 52 | -0.1 g/dL | Standard Deviation 0.7 |
| Part A: Placebo | Change in Biochemistry: Albumin From Baseline at Week 52 | -0.1 g/dL | Standard Deviation 0.3 |
| Part B: Liraglutide | Change in Biochemistry: Albumin From Baseline at Week 52 | 0 g/dL | Standard Deviation 0.2 |
| Part B: Placebo | Change in Biochemistry: Albumin From Baseline at Week 52 | 0 g/dL | Standard Deviation 0.1 |
| Part A+B: Liraglutide | Change in Biochemistry: Albumin From Baseline at Week 52 | 0 g/dL | Standard Deviation 0.5 |
| Part A+B: Placebo | Change in Biochemistry: Albumin From Baseline at Week 52 | -0.1 g/dL | Standard Deviation 0.2 |
Secondary
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16
Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Creatinine kinase: Change from week 0 to week 16 | -3 Units per liter (U/L) | Standard Deviation 37 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Amylase: Change from week 0 to week 16 | 5 Units per liter (U/L) | Standard Deviation 13 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Lipase: Change from week 0 to week 16 | 10 Units per liter (U/L) | Standard Deviation 6 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALT: Change from week 0 to week 16 | -9 Units per liter (U/L) | Standard Deviation 32 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | AST: Change from week 0 to week 16 | -6 Units per liter (U/L) | Standard Deviation 14 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALP: Change from week 0 to week 16 | -10 Units per liter (U/L) | Standard Deviation 12 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Amylase: Change from week 0 to week 16 | -2 Units per liter (U/L) | Standard Deviation 5 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALT: Change from week 0 to week 16 | -4 Units per liter (U/L) | Standard Deviation 18 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALP: Change from week 0 to week 16 | -7 Units per liter (U/L) | Standard Deviation 25 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Creatinine kinase: Change from week 0 to week 16 | 16 Units per liter (U/L) | Standard Deviation 45 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Lipase: Change from week 0 to week 16 | 0 Units per liter (U/L) | Standard Deviation 4 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | AST: Change from week 0 to week 16 | 0 Units per liter (U/L) | Standard Deviation 10 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALP: Change from week 0 to week 16 | -21 Units per liter (U/L) | Standard Deviation 36 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | AST: Change from week 0 to week 16 | -2 Units per liter (U/L) | Standard Deviation 5 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALT: Change from week 0 to week 16 | -2 Units per liter (U/L) | Standard Deviation 6 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Lipase: Change from week 0 to week 16 | 8 Units per liter (U/L) | Standard Deviation 7 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Creatinine kinase: Change from week 0 to week 16 | 3 Units per liter (U/L) | Standard Deviation 23 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Amylase: Change from week 0 to week 16 | 8 Units per liter (U/L) | Standard Deviation 12 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALT: Change from week 0 to week 16 | -25 Units per liter (U/L) | Standard Deviation 23 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Amylase: Change from week 0 to week 16 | 8 Units per liter (U/L) | Standard Deviation 8 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Lipase: Change from week 0 to week 16 | 1 Units per liter (U/L) | Standard Deviation 2 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALP: Change from week 0 to week 16 | -47 Units per liter (U/L) | Standard Deviation 42 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | AST: Change from week 0 to week 16 | -18 Units per liter (U/L) | Standard Deviation 24 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Creatinine kinase: Change from week 0 to week 16 | -5 Units per liter (U/L) | Standard Deviation 5 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Creatinine kinase: Change from week 0 to week 16 | -1 Units per liter (U/L) | Standard Deviation 32 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | AST: Change from week 0 to week 16 | -4 Units per liter (U/L) | Standard Deviation 11 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Amylase: Change from week 0 to week 16 | 6 Units per liter (U/L) | Standard Deviation 13 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Lipase: Change from week 0 to week 16 | 9 Units per liter (U/L) | Standard Deviation 6 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALT: Change from week 0 to week 16 | -6 Units per liter (U/L) | Standard Deviation 25 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALP: Change from week 0 to week 16 | -14 Units per liter (U/L) | Standard Deviation 24 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALT: Change from week 0 to week 16 | -10 Units per liter (U/L) | Standard Deviation 21 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Lipase: Change from week 0 to week 16 | 0 Units per liter (U/L) | Standard Deviation 3 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | AST: Change from week 0 to week 16 | -6 Units per liter (U/L) | Standard Deviation 17 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | ALP: Change from week 0 to week 16 | -19 Units per liter (U/L) | Standard Deviation 35 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Amylase: Change from week 0 to week 16 | 1 Units per liter (U/L) | Standard Deviation 8 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 16 | Creatinine kinase: Change from week 0 to week 16 | 10 Units per liter (U/L) | Standard Deviation 39 |
Secondary
Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52
Change in creatine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Creatinine kinase: Change from week 0 to week 52 | 30 Units per liter (U/L) | Standard Deviation 206 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Amylase: Change from week 0 to week 52 | 4 Units per liter (U/L) | Standard Deviation 10 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Lipase: Change from week 0 to week 52 | 9 Units per liter (U/L) | Standard Deviation 9 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALT: Change from week 0 to week 52 | 1 Units per liter (U/L) | Standard Deviation 12 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | AST: Change from week 0 to week 52 | -2 Units per liter (U/L) | Standard Deviation 7 |
| Part A: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALP: Change from week 0 to week 52 | -24 Units per liter (U/L) | Standard Deviation 27 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Amylase: Change from week 0 to week 52 | 2 Units per liter (U/L) | Standard Deviation 12 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALT: Change from week 0 to week 52 | 4 Units per liter (U/L) | Standard Deviation 25 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALP: Change from week 0 to week 52 | -35 Units per liter (U/L) | Standard Deviation 27 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Creatinine kinase: Change from week 0 to week 52 | -4 Units per liter (U/L) | Standard Deviation 29 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Lipase: Change from week 0 to week 52 | -1 Units per liter (U/L) | Standard Deviation 3 |
| Part A: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | AST: Change from week 0 to week 52 | 9 Units per liter (U/L) | Standard Deviation 31 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALP: Change from week 0 to week 52 | -25 Units per liter (U/L) | Standard Deviation 59 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | AST: Change from week 0 to week 52 | 1 Units per liter (U/L) | Standard Deviation 7 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALT: Change from week 0 to week 52 | 0 Units per liter (U/L) | Standard Deviation 16 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Lipase: Change from week 0 to week 52 | 7 Units per liter (U/L) | Standard Deviation 6 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Creatinine kinase: Change from week 0 to week 52 | 25 Units per liter (U/L) | Standard Deviation 42 |
| Part B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Amylase: Change from week 0 to week 52 | 7 Units per liter (U/L) | Standard Deviation 12 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALT: Change from week 0 to week 52 | -24 Units per liter (U/L) | Standard Deviation 28 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Amylase: Change from week 0 to week 52 | 8 Units per liter (U/L) | Standard Deviation 5 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Lipase: Change from week 0 to week 52 | 3 Units per liter (U/L) | Standard Deviation 5 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALP: Change from week 0 to week 52 | -26 Units per liter (U/L) | Standard Deviation 60 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | AST: Change from week 0 to week 52 | -21 Units per liter (U/L) | Standard Deviation 32 |
| Part B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Creatinine kinase: Change from week 0 to week 52 | -8 Units per liter (U/L) | Standard Deviation 25 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Creatinine kinase: Change from week 0 to week 52 | 28 Units per liter (U/L) | Standard Deviation 159 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | AST: Change from week 0 to week 52 | -1 Units per liter (U/L) | Standard Deviation 7 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Amylase: Change from week 0 to week 52 | 5 Units per liter (U/L) | Standard Deviation 11 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Lipase: Change from week 0 to week 52 | 8 Units per liter (U/L) | Standard Deviation 8 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALT: Change from week 0 to week 52 | 1 Units per liter (U/L) | Standard Deviation 14 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALP: Change from week 0 to week 52 | -24 Units per liter (U/L) | Standard Deviation 42 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALT: Change from week 0 to week 52 | -6 Units per liter (U/L) | Standard Deviation 29 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Lipase: Change from week 0 to week 52 | 0 Units per liter (U/L) | Standard Deviation 4 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | AST: Change from week 0 to week 52 | 0 Units per liter (U/L) | Standard Deviation 33 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | ALP: Change from week 0 to week 52 | -32 Units per liter (U/L) | Standard Deviation 39 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Amylase: Change from week 0 to week 52 | 4 Units per liter (U/L) | Standard Deviation 11 |
| Part A+B: Placebo | Change in Biochemistry: Creatine Kinase, Amylase, Lipase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) From Baseline at Week 52 | Creatinine kinase: Change from week 0 to week 52 | -5 Units per liter (U/L) | Standard Deviation 27 |
Secondary
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16
Change in creatinine and bilirubin (total) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Creatinine: Change from week 0 to week 16 | 1 micro mole per liter (umol/L) | Standard Deviation 5 |
| Part A: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Bilirubin (total): Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 2 |
| Part A: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Creatinine: Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 6 |
| Part A: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Bilirubin (total): Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 2 |
| Part B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Creatinine: Change from week 0 to week 16 | 2 micro mole per liter (umol/L) | Standard Deviation 7 |
| Part B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Bilirubin (total): Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 2 |
| Part B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Creatinine: Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 6 |
| Part B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Bilirubin (total): Change from week 0 to week 16 | 1 micro mole per liter (umol/L) | Standard Deviation 2 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Creatinine: Change from week 0 to week 16 | 1 micro mole per liter (umol/L) | Standard Deviation 5 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Bilirubin (total): Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 2 |
| Part A+B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Creatinine: Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 6 |
| Part A+B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 16 | Bilirubin (total): Change from week 0 to week 16 | 0 micro mole per liter (umol/L) | Standard Deviation 2 |
Secondary
Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52
Change in creatinine and bilirubin (total) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Creatinine: Change from week 0 to week 52 | 3 umol/L | Standard Deviation 8 |
| Part A: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Bilirubin (total): Change from week 0 to week 52 | 0 umol/L | Standard Deviation 2 |
| Part A: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Creatinine: Change from week 0 to week 52 | -4 umol/L | Standard Deviation 9 |
| Part A: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Bilirubin (total): Change from week 0 to week 52 | 2 umol/L | Standard Deviation 3 |
| Part B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Creatinine: Change from week 0 to week 52 | 3 umol/L | Standard Deviation 6 |
| Part B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Bilirubin (total): Change from week 0 to week 52 | 0 umol/L | Standard Deviation 1 |
| Part B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Creatinine: Change from week 0 to week 52 | 5 umol/L | Standard Deviation 3 |
| Part B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Bilirubin (total): Change from week 0 to week 52 | 2 umol/L | Standard Deviation 3 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Creatinine: Change from week 0 to week 52 | 3 umol/L | Standard Deviation 7 |
| Part A+B: Liraglutide | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Bilirubin (total): Change from week 0 to week 52 | 0 umol/L | Standard Deviation 2 |
| Part A+B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Creatinine: Change from week 0 to week 52 | -1 umol/L | Standard Deviation 9 |
| Part A+B: Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) From Baseline at Week 52 | Bilirubin (total): Change from week 0 to week 52 | 2 umol/L | Standard Deviation 3 |
Secondary
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16
Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Urea: Change from week 0 to week 16 | 0.03 mmol/L | Standard Deviation 1.45 |
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Sodium: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 5 |
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Potassium: Change from week 0 to week 16 | 0.1 mmol/L | Standard Deviation 0.4 |
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Calcium: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 0.12 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Potassium: Change from week 0 to week 16 | -0.1 mmol/L | Standard Deviation 0.3 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Sodium: Change from week 0 to week 16 | 2 mmol/L | Standard Deviation 3 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Urea: Change from week 0 to week 16 | -0.51 mmol/L | Standard Deviation 0.67 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Calcium: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 0.1 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Calcium: Change from week 0 to week 16 | 0.08 mmol/L | Standard Deviation 0.17 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Potassium: Change from week 0 to week 16 | -0.2 mmol/L | Standard Deviation 0.6 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Sodium: Change from week 0 to week 16 | 1 mmol/L | Standard Deviation 4 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Urea: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 0.99 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Urea: Change from week 0 to week 16 | 0.09 mmol/L | Standard Deviation 2.19 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Calcium: Change from week 0 to week 16 | 0.02 mmol/L | Standard Deviation 0.1 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Sodium: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 1 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Potassium: Change from week 0 to week 16 | -0.1 mmol/L | Standard Deviation 0.2 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Potassium: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 0.5 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Calcium: Change from week 0 to week 16 | 0.03 mmol/L | Standard Deviation 0.14 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Sodium: Change from week 0 to week 16 | 0 mmol/L | Standard Deviation 4 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Urea: Change from week 0 to week 16 | 0.02 mmol/L | Standard Deviation 1.26 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Sodium: Change from week 0 to week 16 | 1 mmol/L | Standard Deviation 3 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Potassium: Change from week 0 to week 16 | -0.1 mmol/L | Standard Deviation 0.2 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Calcium: Change from week 0 to week 16 | 0.01 mmol/L | Standard Deviation 0.1 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 16 | Urea: Change from week 0 to week 16 | -0.31 mmol/L | Standard Deviation 1.33 |
Secondary
Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52
Change in urea, sodium, potassium, calcium total and calcium albumin-corrected from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Urea: Change from week 0 to week 52 | -0.38 mmol/L | Standard Deviation 1.56 |
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Sodium: Change from week 0 to week 52 | -1 mmol/L | Standard Deviation 5 |
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Potassium: Change from week 0 to week 52 | -0.2 mmol/L | Standard Deviation 0.6 |
| Part A: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Calcium: Change from week 0 to week 52 | -0.05 mmol/L | Standard Deviation 0.14 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Potassium: Change from week 0 to week 52 | -0.1 mmol/L | Standard Deviation 0.2 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Sodium: Change from week 0 to week 52 | -2 mmol/L | Standard Deviation 5 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Urea: Change from week 0 to week 52 | -0.34 mmol/L | Standard Deviation 0.54 |
| Part A: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Calcium: Change from week 0 to week 52 | -0.11 mmol/L | Standard Deviation 0.12 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Calcium: Change from week 0 to week 52 | 0.09 mmol/L | Standard Deviation 0.14 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Potassium: Change from week 0 to week 52 | -0.2 mmol/L | Standard Deviation 0.7 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Sodium: Change from week 0 to week 52 | 1 mmol/L | Standard Deviation 4 |
| Part B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Urea: Change from week 0 to week 52 | -0.21 mmol/L | Standard Deviation 1 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Urea: Change from week 0 to week 52 | -0.04 mmol/L | Standard Deviation 1.08 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Calcium: Change from week 0 to week 52 | 0 mmol/L | Standard Deviation 0.02 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Sodium: Change from week 0 to week 52 | 2 mmol/L | Standard Deviation 2 |
| Part B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Potassium: Change from week 0 to week 52 | 0 mmol/L | Standard Deviation 0.2 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Potassium: Change from week 0 to week 52 | -0.2 mmol/L | Standard Deviation 0.6 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Calcium: Change from week 0 to week 52 | 0.01 mmol/L | Standard Deviation 0.15 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Sodium: Change from week 0 to week 52 | 0 mmol/L | Standard Deviation 4 |
| Part A+B: Liraglutide | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Urea: Change from week 0 to week 52 | -0.31 mmol/L | Standard Deviation 1.34 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Sodium: Change from week 0 to week 52 | -1 mmol/L | Standard Deviation 4 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Potassium: Change from week 0 to week 52 | -0.1 mmol/L | Standard Deviation 0.2 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Calcium: Change from week 0 to week 52 | -0.08 mmol/L | Standard Deviation 0.11 |
| Part A+B: Placebo | Change in Biochemistry: Urea, Sodium, Potassium, Calcium Total and Calcium Albumin-corrected From Baseline at Week 52 | Urea: Change from week 0 to week 52 | -0.24 mmol/L | Standard Deviation 0.74 |
Secondary
Change in BMI From Baseline at Week 16
Change in body mass index (BMI) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in BMI From Baseline at Week 16 | -0.9 kilogram per meter square (kg/m^2) | Standard Deviation 1.4 |
| Part A: Placebo | Change in BMI From Baseline at Week 16 | -0.8 kilogram per meter square (kg/m^2) | Standard Deviation 1.6 |
| Part B: Liraglutide | Change in BMI From Baseline at Week 16 | -1.1 kilogram per meter square (kg/m^2) | Standard Deviation 1.5 |
| Part B: Placebo | Change in BMI From Baseline at Week 16 | -1.5 kilogram per meter square (kg/m^2) | Standard Deviation 1.7 |
| Part A+B: Liraglutide | Change in BMI From Baseline at Week 16 | -1.0 kilogram per meter square (kg/m^2) | Standard Deviation 1.4 |
| Part A+B: Placebo | Change in BMI From Baseline at Week 16 | -1.1 kilogram per meter square (kg/m^2) | Standard Deviation 1.6 |
Secondary
Change in BMI From Baseline at Week 52
Change in body mass index (BMI) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in BMI From Baseline at Week 52 | 0.8 kg/m^2 | Standard Deviation 2.2 |
| Part A: Placebo | Change in BMI From Baseline at Week 52 | -0.1 kg/m^2 | Standard Deviation 2.1 |
| Part B: Liraglutide | Change in BMI From Baseline at Week 52 | -0.6 kg/m^2 | Standard Deviation 3.3 |
| Part B: Placebo | Change in BMI From Baseline at Week 52 | -0.7 kg/m^2 | Standard Deviation 2.7 |
| Part A+B: Liraglutide | Change in BMI From Baseline at Week 52 | -0.7 kg/m^2 | Standard Deviation 2.7 |
| Part A+B: Placebo | Change in BMI From Baseline at Week 52 | -0.4 kg/m^2 | Standard Deviation 2.3 |
Secondary
Change in Body Weight (%) From Baseline at Week 52
Change in body weight (%) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Weight (%) From Baseline at Week 52 | -0.4 Percent change in body weight | Standard Deviation 6.5 |
| Part A: Placebo | Change in Body Weight (%) From Baseline at Week 52 | 2.3 Percent change in body weight | Standard Deviation 5.7 |
| Part B: Liraglutide | Change in Body Weight (%) From Baseline at Week 52 | 6.3 Percent change in body weight | Standard Deviation 12.1 |
| Part B: Placebo | Change in Body Weight (%) From Baseline at Week 52 | 4.9 Percent change in body weight | Standard Deviation 8.6 |
| Part A+B: Liraglutide | Change in Body Weight (%) From Baseline at Week 52 | 2.6 Percent change in body weight | Standard Deviation 9.9 |
| Part A+B: Placebo | Change in Body Weight (%) From Baseline at Week 52 | 3.3 Percent change in body weight | Standard Deviation 6.9 |
Secondary
Change in Body Weight (kg) From Baseline at Week 52
Change in body weight (kg) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. (kilogram (kg))
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Weight (kg) From Baseline at Week 52 | -0.4 kilogram | Standard Deviation 6.3 |
| Part A: Placebo | Change in Body Weight (kg) From Baseline at Week 52 | 1.9 kilogram | Standard Deviation 6 |
| Part B: Liraglutide | Change in Body Weight (kg) From Baseline at Week 52 | 3.0 kilogram | Standard Deviation 6.6 |
| Part B: Placebo | Change in Body Weight (kg) From Baseline at Week 52 | 2.8 kilogram | Standard Deviation 5.2 |
| Part A+B: Liraglutide | Change in Body Weight (kg) From Baseline at Week 52 | 1.1 kilogram | Standard Deviation 6.5 |
| Part A+B: Placebo | Change in Body Weight (kg) From Baseline at Week 52 | 2.3 kilogram | Standard Deviation 5.6 |
Secondary
Change in Body Weight (Kilogram (kg)) From Baseline at Week 16
Change in body weight (kg) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | -1.7 (kilogram (kg)) | Standard Deviation 3.6 |
| Part A: Placebo | Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | -1.1 (kilogram (kg)) | Standard Deviation 5 |
| Part B: Liraglutide | Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | -0.6 (kilogram (kg)) | Standard Deviation 2.2 |
| Part B: Placebo | Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | -1.0 (kilogram (kg)) | Standard Deviation 2.7 |
| Part A+B: Liraglutide | Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | -1.2 (kilogram (kg)) | Standard Deviation 3 |
| Part A+B: Placebo | Change in Body Weight (Kilogram (kg)) From Baseline at Week 16 | -1.0 (kilogram (kg)) | Standard Deviation 4.2 |
Secondary
Change in Body Weight (lb) From Baseline at Week 52
Change in body weight (lb) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Weight (lb) From Baseline at Week 52 | -0.9 pounds | Standard Deviation 13.9 |
| Part A: Placebo | Change in Body Weight (lb) From Baseline at Week 52 | 4.3 pounds | Standard Deviation 13.2 |
| Part B: Liraglutide | Change in Body Weight (lb) From Baseline at Week 52 | 6.7 pounds | Standard Deviation 14.4 |
| Part B: Placebo | Change in Body Weight (lb) From Baseline at Week 52 | 6.2 pounds | Standard Deviation 11.5 |
| Part A+B: Liraglutide | Change in Body Weight (lb) From Baseline at Week 52 | 2.5 pounds | Standard Deviation 14.4 |
| Part A+B: Placebo | Change in Body Weight (lb) From Baseline at Week 52 | 5.0 pounds | Standard Deviation 12.3 |
Secondary
Change in Body Weight (Percentage [%]) From Baseline at Week 16
Change in body weight (%) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Weight (Percentage [%]) From Baseline at Week 16 | -1.7 Percent change in body weight | Standard Deviation 3.8 |
| Part A: Placebo | Change in Body Weight (Percentage [%]) From Baseline at Week 16 | -0.7 Percent change in body weight | Standard Deviation 3.7 |
| Part B: Liraglutide | Change in Body Weight (Percentage [%]) From Baseline at Week 16 | -1.1 Percent change in body weight | Standard Deviation 4.1 |
| Part B: Placebo | Change in Body Weight (Percentage [%]) From Baseline at Week 16 | -2.2 Percent change in body weight | Standard Deviation 5.5 |
| Part A+B: Liraglutide | Change in Body Weight (Percentage [%]) From Baseline at Week 16 | -1.4 Percent change in body weight | Standard Deviation 3.9 |
| Part A+B: Placebo | Change in Body Weight (Percentage [%]) From Baseline at Week 16 | -1.2 Percent change in body weight | Standard Deviation 4.3 |
Secondary
Change in Body Weight (Pounds (lb)) From Baseline at Week 16
Change in body weight (lb) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | -3.7 pounds (lb) | Standard Deviation 7.8 |
| Part A: Placebo | Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | -2.4 pounds (lb) | Standard Deviation 11 |
| Part B: Liraglutide | Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | -1.4 pounds (lb) | Standard Deviation 4.8 |
| Part B: Placebo | Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | -2.1 pounds (lb) | Standard Deviation 5.9 |
| Part A+B: Liraglutide | Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | -2.6 pounds (lb) | Standard Deviation 6.6 |
| Part A+B: Placebo | Change in Body Weight (Pounds (lb)) From Baseline at Week 16 | -2.3 pounds (lb) | Standard Deviation 9.2 |
Secondary
Change in Fasting C Peptide From Baseline at Week 16
Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting C Peptide From Baseline at Week 16 | 1.14 Ratio of fasting C peptide | Standard Deviation 0.56 |
| Part A: Placebo | Change in Fasting C Peptide From Baseline at Week 16 | 0.86 Ratio of fasting C peptide | Standard Deviation 0.2 |
| Part B: Liraglutide | Change in Fasting C Peptide From Baseline at Week 16 | 1.11 Ratio of fasting C peptide | Standard Deviation 0.5 |
| Part B: Placebo | Change in Fasting C Peptide From Baseline at Week 16 | 1.08 Ratio of fasting C peptide | Standard Deviation 0.44 |
| Part A+B: Liraglutide | Change in Fasting C Peptide From Baseline at Week 16 | 1.13 Ratio of fasting C peptide | Standard Deviation 0.53 |
| Part A+B: Placebo | Change in Fasting C Peptide From Baseline at Week 16 | 0.94 Ratio of fasting C peptide | Standard Deviation 0.31 |
Secondary
Change in Fasting C Peptide From Baseline at Week 52
Change in fasting C peptide (measured as nano moles per liter (nmol/L)) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting C Peptide From Baseline at Week 52 | 1.34 Ratio of fasting C peptide | Standard Deviation 0.92 |
| Part A: Placebo | Change in Fasting C Peptide From Baseline at Week 52 | 0.91 Ratio of fasting C peptide | Standard Deviation 0.23 |
| Part B: Liraglutide | Change in Fasting C Peptide From Baseline at Week 52 | 1.15 Ratio of fasting C peptide | Standard Deviation 0.45 |
| Part B: Placebo | Change in Fasting C Peptide From Baseline at Week 52 | 1.09 Ratio of fasting C peptide | Standard Deviation 0.3 |
| Part A+B: Liraglutide | Change in Fasting C Peptide From Baseline at Week 52 | 1.26 Ratio of fasting C peptide | Standard Deviation 0.75 |
| Part A+B: Placebo | Change in Fasting C Peptide From Baseline at Week 52 | 0.98 Ratio of fasting C peptide | Standard Deviation 0.26 |
Secondary
Change in Fasting Insulin From Baseline at Week 16
Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting Insulin From Baseline at Week 16 | 1.59 Ratio of fasting insulin | Standard Deviation 1.91 |
| Part A: Placebo | Change in Fasting Insulin From Baseline at Week 16 | 0.78 Ratio of fasting insulin | Standard Deviation 0.32 |
| Part B: Liraglutide | Change in Fasting Insulin From Baseline at Week 16 | 1.43 Ratio of fasting insulin | Standard Deviation 1.17 |
| Part B: Placebo | Change in Fasting Insulin From Baseline at Week 16 | 1.32 Ratio of fasting insulin | Standard Deviation 0.68 |
| Part A+B: Liraglutide | Change in Fasting Insulin From Baseline at Week 16 | 1.52 Ratio of fasting insulin | Standard Deviation 1.62 |
| Part A+B: Placebo | Change in Fasting Insulin From Baseline at Week 16 | 0.97 Ratio of fasting insulin | Standard Deviation 0.53 |
Secondary
Change in Fasting Insulin From Baseline at Week 52
Change in fasting insulin (measured as picomoles per litre (pmol/L)) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting Insulin From Baseline at Week 52 | 2.03 Ratio of fasting insulin | Standard Deviation 2.33 |
| Part A: Placebo | Change in Fasting Insulin From Baseline at Week 52 | 0.79 Ratio of fasting insulin | Standard Deviation 0.37 |
| Part B: Liraglutide | Change in Fasting Insulin From Baseline at Week 52 | 1.45 Ratio of fasting insulin | Standard Deviation 1.27 |
| Part B: Placebo | Change in Fasting Insulin From Baseline at Week 52 | 1.22 Ratio of fasting insulin | Standard Deviation 0.44 |
| Part A+B: Liraglutide | Change in Fasting Insulin From Baseline at Week 52 | 1.78 Ratio of fasting insulin | Standard Deviation 1.94 |
| Part A+B: Placebo | Change in Fasting Insulin From Baseline at Week 52 | 0.96 Ratio of fasting insulin | Standard Deviation 0.44 |
Secondary
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16
Change in free fatty acids (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | 1.52 Ratio of FFA | Standard Deviation 1.6 |
| Part A: Placebo | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | 1.31 Ratio of FFA | Standard Deviation 0.61 |
| Part B: Liraglutide | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | 1.04 Ratio of FFA | Standard Deviation 0.35 |
| Part B: Placebo | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | 0.99 Ratio of FFA | Standard Deviation 0.3 |
| Part A+B: Liraglutide | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | 1.31 Ratio of FFA | Standard Deviation 1.21 |
| Part A+B: Placebo | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 16 | 1.21 Ratio of FFA | Standard Deviation 0.55 |
Secondary
Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52
Change in free fatty acids (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | 1.15 Ratio of FFA | Standard Deviation 0.76 |
| Part A: Placebo | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | 1.45 Ratio of FFA | Standard Deviation 0.49 |
| Part B: Liraglutide | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | 0.85 Ratio of FFA | Standard Deviation 0.51 |
| Part B: Placebo | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | 1.05 Ratio of FFA | Standard Deviation 0.25 |
| Part A+B: Liraglutide | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | 1.01 Ratio of FFA | Standard Deviation 0.67 |
| Part A+B: Placebo | Change in Fasting Lipid: Free Fatty Acids (FFA) From Baseline at Week 52 | 1.32 Ratio of FFA | Standard Deviation 0.45 |
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16
Change in FPG from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | -0.2 mmol/L | Standard Deviation 0.5 |
| Part A: Placebo | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | 0.1 mmol/L | Standard Deviation 0.5 |
| Part B: Liraglutide | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | -0.1 mmol/L | Standard Deviation 0.5 |
| Part B: Placebo | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | 0.2 mmol/L | Standard Deviation 0.4 |
| Part A+B: Liraglutide | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | -0.2 mmol/L | Standard Deviation 0.5 |
| Part A+B: Placebo | Change in Fasting Plasma Glucose (FPG) From Baseline at Week 16 | 0.1 mmol/L | Standard Deviation 0.4 |
Secondary
Change in FPG From Baseline at Week 52
Change in FPG from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in FPG From Baseline at Week 52 | 0 mmol/L | Standard Deviation 0.7 |
| Part A: Placebo | Change in FPG From Baseline at Week 52 | 0.3 mmol/L | Standard Deviation 0.8 |
| Part B: Liraglutide | Change in FPG From Baseline at Week 52 | 0 mmol/L | Standard Deviation 0.4 |
| Part B: Placebo | Change in FPG From Baseline at Week 52 | 0 mmol/L | Standard Deviation 0.4 |
| Part A+B: Liraglutide | Change in FPG From Baseline at Week 52 | 0 mmol/L | Standard Deviation 0.6 |
| Part A+B: Placebo | Change in FPG From Baseline at Week 52 | 0.2 mmol/L | Standard Deviation 0.7 |
Secondary
Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16
Change in HbA1c from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | -0.2 Percentage point of HbA1c | Standard Deviation 0.1 |
| Part A: Placebo | Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | 0 Percentage point of HbA1c | Standard Deviation 0.3 |
| Part B: Liraglutide | Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | -0.2 Percentage point of HbA1c | Standard Deviation 0.3 |
| Part B: Placebo | Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | -0.2 Percentage point of HbA1c | Standard Deviation 0.3 |
| Part A+B: Liraglutide | Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | -0.2 Percentage point of HbA1c | Standard Deviation 0.2 |
| Part A+B: Placebo | Change in Glycosylated Haemoglobin (HbA1c) From Baseline at Week 16 | -0.1 Percentage point of HbA1c | Standard Deviation 0.3 |
Secondary
Change in Haematology: Erythrocytes From Baseline at Week 16
Change in erythrocytes from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Erythrocytes From Baseline at Week 16 | -0.1 10^12 cells per liter (10^12/L) | Standard Deviation 0.2 |
| Part A: Placebo | Change in Haematology: Erythrocytes From Baseline at Week 16 | 0 10^12 cells per liter (10^12/L) | Standard Deviation 0.2 |
| Part B: Liraglutide | Change in Haematology: Erythrocytes From Baseline at Week 16 | 0.1 10^12 cells per liter (10^12/L) | Standard Deviation 0.3 |
| Part B: Placebo | Change in Haematology: Erythrocytes From Baseline at Week 16 | 0 10^12 cells per liter (10^12/L) | Standard Deviation 0.3 |
| Part A+B: Liraglutide | Change in Haematology: Erythrocytes From Baseline at Week 16 | -0.1 10^12 cells per liter (10^12/L) | Standard Deviation 0.3 |
| Part A+B: Placebo | Change in Haematology: Erythrocytes From Baseline at Week 16 | 0 10^12 cells per liter (10^12/L) | Standard Deviation 0.2 |
Secondary
Change in Haematology: Erythrocytes From Baseline at Week 52
Change in erythrocytes from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Erythrocytes From Baseline at Week 52 | -0.1 10^12 cells per liter (10^12/L) | Standard Deviation 0.4 |
| Part A: Placebo | Change in Haematology: Erythrocytes From Baseline at Week 52 | 0 10^12 cells per liter (10^12/L) | Standard Deviation 0.2 |
| Part B: Liraglutide | Change in Haematology: Erythrocytes From Baseline at Week 52 | -0.1 10^12 cells per liter (10^12/L) | Standard Deviation 0.3 |
| Part B: Placebo | Change in Haematology: Erythrocytes From Baseline at Week 52 | 0 10^12 cells per liter (10^12/L) | Standard Deviation 0 |
| Part A+B: Liraglutide | Change in Haematology: Erythrocytes From Baseline at Week 52 | -0.1 10^12 cells per liter (10^12/L) | Standard Deviation 0.4 |
| Part A+B: Placebo | Change in Haematology: Erythrocytes From Baseline at Week 52 | 0 10^12 cells per liter (10^12/L) | Standard Deviation 0.1 |
Secondary
Change in Haematology: Haematocrit From Baseline at Week 16
Change in haematocrit from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Haematocrit From Baseline at Week 16 | -1.8 Percentage of haematocrit in blood | Standard Deviation 2.1 |
| Part A: Placebo | Change in Haematology: Haematocrit From Baseline at Week 16 | -0.5 Percentage of haematocrit in blood | Standard Deviation 1.3 |
| Part B: Liraglutide | Change in Haematology: Haematocrit From Baseline at Week 16 | 0.4 Percentage of haematocrit in blood | Standard Deviation 2.6 |
| Part B: Placebo | Change in Haematology: Haematocrit From Baseline at Week 16 | -0.6 Percentage of haematocrit in blood | Standard Deviation 3.3 |
| Part A+B: Liraglutide | Change in Haematology: Haematocrit From Baseline at Week 16 | -0.9 Percentage of haematocrit in blood | Standard Deviation 2.6 |
| Part A+B: Placebo | Change in Haematology: Haematocrit From Baseline at Week 16 | -0.5 Percentage of haematocrit in blood | Standard Deviation 2.1 |
Secondary
Change in Haematology: Haematocrit From Baseline at Week 52
Change in haematocrit from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Haematocrit From Baseline at Week 52 | -1.4 Percentage of haematocrit in blood | Standard Deviation 4 |
| Part A: Placebo | Change in Haematology: Haematocrit From Baseline at Week 52 | 0 Percentage of haematocrit in blood | Standard Deviation 1.7 |
| Part B: Liraglutide | Change in Haematology: Haematocrit From Baseline at Week 52 | -0.2 Percentage of haematocrit in blood | Standard Deviation 2.7 |
| Part B: Placebo | Change in Haematology: Haematocrit From Baseline at Week 52 | -0.8 Percentage of haematocrit in blood | Standard Deviation 2.6 |
| Part A+B: Liraglutide | Change in Haematology: Haematocrit From Baseline at Week 52 | -0.9 Percentage of haematocrit in blood | Standard Deviation 3.5 |
| Part A+B: Placebo | Change in Haematology: Haematocrit From Baseline at Week 52 | -0.3 Percentage of haematocrit in blood | Standard Deviation 1.9 |
Secondary
Change in Haematology: Haemoglobin From Baseline at Week 16
Change in haemoglobin from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Haemoglobin From Baseline at Week 16 | -0.18 millimoles per liter (mmol/L) | Standard Deviation 0.43 |
| Part A: Placebo | Change in Haematology: Haemoglobin From Baseline at Week 16 | 0.06 millimoles per liter (mmol/L) | Standard Deviation 0.28 |
| Part B: Liraglutide | Change in Haematology: Haemoglobin From Baseline at Week 16 | -0.20 millimoles per liter (mmol/L) | Standard Deviation 1.22 |
| Part B: Placebo | Change in Haematology: Haemoglobin From Baseline at Week 16 | -0.07 millimoles per liter (mmol/L) | Standard Deviation 0.55 |
| Part A+B: Liraglutide | Change in Haematology: Haemoglobin From Baseline at Week 16 | -0.19 millimoles per liter (mmol/L) | Standard Deviation 0.84 |
| Part A+B: Placebo | Change in Haematology: Haemoglobin From Baseline at Week 16 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.38 |
Secondary
Change in Haematology: Haemoglobin From Baseline at Week 52
Change in haemoglobin from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Haemoglobin From Baseline at Week 52 | -0.14 mmol/L | Standard Deviation 0.79 |
| Part A: Placebo | Change in Haematology: Haemoglobin From Baseline at Week 52 | -0.01 mmol/L | Standard Deviation 0.31 |
| Part B: Liraglutide | Change in Haematology: Haemoglobin From Baseline at Week 52 | -0.02 mmol/L | Standard Deviation 0.61 |
| Part B: Placebo | Change in Haematology: Haemoglobin From Baseline at Week 52 | -0.02 mmol/L | Standard Deviation 0.2 |
| Part A+B: Liraglutide | Change in Haematology: Haemoglobin From Baseline at Week 52 | -0.09 mmol/L | Standard Deviation 0.72 |
| Part A+B: Placebo | Change in Haematology: Haemoglobin From Baseline at Week 52 | -0.01 mmol/L | Standard Deviation 0.28 |
Secondary
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16
Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Thrombocytes: Change from week 0 to week 16 | 6 10^9 cells per liter (10^9/L) | Standard Deviation 35 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Basophils: Change from week 0 to week 16 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.02 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Leukocytes: Change from week 0 to week 16 | -0.1 10^9 cells per liter (10^9/L) | Standard Deviation 1.5 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Monocytes: Change from week 0 to week 16 | 0.06 10^9 cells per liter (10^9/L) | Standard Deviation 0.17 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Eosinophils: Change from week 0 to week 16 | -0.03 10^9 cells per liter (10^9/L) | Standard Deviation 0.09 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Lymphocytes: Change from week 0 to week 16 | -0.24 10^9 cells per liter (10^9/L) | Standard Deviation 0.66 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Neutrophils: Change from week 0 to week 16 | 0.11 10^9 cells per liter (10^9/L) | Standard Deviation 1.08 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Leukocytes: Change from week 0 to week 16 | -0.3 10^9 cells per liter (10^9/L) | Standard Deviation 1.6 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Neutrophils: Change from week 0 to week 16 | -0.22 10^9 cells per liter (10^9/L) | Standard Deviation 1.62 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Eosinophils: Change from week 0 to week 16 | 0.04 10^9 cells per liter (10^9/L) | Standard Deviation 0.07 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Basophils: Change from week 0 to week 16 | 0 10^9 cells per liter (10^9/L) | Standard Deviation 0.02 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Thrombocytes: Change from week 0 to week 16 | -21 10^9 cells per liter (10^9/L) | Standard Deviation 26 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Monocytes: Change from week 0 to week 16 | -0.04 10^9 cells per liter (10^9/L) | Standard Deviation 0.12 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Lymphocytes: Change from week 0 to week 16 | -0.09 10^9 cells per liter (10^9/L) | Standard Deviation 0.97 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Eosinophils: Change from week 0 to week 16 | -0.14 10^9 cells per liter (10^9/L) | Standard Deviation 0.27 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Leukocytes: Change from week 0 to week 16 | -0.8 10^9 cells per liter (10^9/L) | Standard Deviation 2.3 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Thrombocytes: Change from week 0 to week 16 | 8 10^9 cells per liter (10^9/L) | Standard Deviation 66 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Basophils: Change from week 0 to week 16 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Lymphocytes: Change from week 0 to week 16 | -0.36 10^9 cells per liter (10^9/L) | Standard Deviation 0.89 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Neutrophils: Change from week 0 to week 16 | -0.28 10^9 cells per liter (10^9/L) | Standard Deviation 1.59 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Monocytes: Change from week 0 to week 16 | -0.05 10^9 cells per liter (10^9/L) | Standard Deviation 0.17 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Neutrophils: Change from week 0 to week 16 | -1.35 10^9 cells per liter (10^9/L) | Standard Deviation 1.33 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Thrombocytes: Change from week 0 to week 16 | 19 10^9 cells per liter (10^9/L) | Standard Deviation 18 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Leukocytes: Change from week 0 to week 16 | -1.1 10^9 cells per liter (10^9/L) | Standard Deviation 1.7 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Eosinophils: Change from week 0 to week 16 | 0.07 10^9 cells per liter (10^9/L) | Standard Deviation 0.32 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Basophils: Change from week 0 to week 16 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Lymphocytes: Change from week 0 to week 16 | 0.09 10^9 cells per liter (10^9/L) | Standard Deviation 0.85 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Monocytes: Change from week 0 to week 16 | 0.05 10^9 cells per liter (10^9/L) | Standard Deviation 0.2 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Eosinophils: Change from week 0 to week 16 | -0.07 10^9 cells per liter (10^9/L) | Standard Deviation 0.2 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Leukocytes: Change from week 0 to week 16 | -0.4 10^9 cells per liter (10^9/L) | Standard Deviation 1.9 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Monocytes: Change from week 0 to week 16 | 0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.18 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Thrombocytes: Change from week 0 to week 16 | 7 10^9 cells per liter (10^9/L) | Standard Deviation 49 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Lymphocytes: Change from week 0 to week 16 | -0.29 10^9 cells per liter (10^9/L) | Standard Deviation 0.76 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Neutrophils: Change from week 0 to week 16 | -0.06 10^9 cells per liter (10^9/L) | Standard Deviation 1.31 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Basophils: Change from week 0 to week 16 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.03 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Monocytes: Change from week 0 to week 16 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.15 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Basophils: Change from week 0 to week 16 | 0 10^9 cells per liter (10^9/L) | Standard Deviation 0.03 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Eosinophils: Change from week 0 to week 16 | 0.05 10^9 cells per liter (10^9/L) | Standard Deviation 0.19 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Leukocytes: Change from week 0 to week 16 | -0.6 10^9 cells per liter (10^9/L) | Standard Deviation 1.6 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Lymphocytes: Change from week 0 to week 16 | -0.02 10^9 cells per liter (10^9/L) | Standard Deviation 0.91 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Thrombocytes: Change from week 0 to week 16 | -8 10^9 cells per liter (10^9/L) | Standard Deviation 30 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 16 | Neutrophils: Change from week 0 to week 16 | -0.62 10^9 cells per liter (10^9/L) | Standard Deviation 1.58 |
Secondary
Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52
Change in thrombocytes, leukocytes, eosinophils, neutrophils, basophils, lymphocytes, monocytes from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Thrombocytes: Change from week 0 to week 52 | 18 10^9 cells per liter (10^9/L) | Standard Deviation 44 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Basophils: Change from week 0 to week 52 | 0 10^9 cells per liter (10^9/L) | Standard Deviation 0.03 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Leukocytes: Change from week 0 to week 52 | -0.2 10^9 cells per liter (10^9/L) | Standard Deviation 1.1 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Monocytes: Change from week 0 to week 52 | -0.04 10^9 cells per liter (10^9/L) | Standard Deviation 0.19 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Eosinophils: Change from week 0 to week 52 | 0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.11 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Lymphocytes: Change from week 0 to week 52 | -0.28 10^9 cells per liter (10^9/L) | Standard Deviation 0.67 |
| Part A: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Neutrophils: Change from week 0 to week 52 | 0.11 10^9 cells per liter (10^9/L) | Standard Deviation 1.17 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Leukocytes: Change from week 0 to week 52 | -0.6 10^9 cells per liter (10^9/L) | Standard Deviation 1.7 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Neutrophils: Change from week 0 to week 52 | -0.76 10^9 cells per liter (10^9/L) | Standard Deviation 1.4 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Eosinophils: Change from week 0 to week 52 | 0.03 10^9 cells per liter (10^9/L) | Standard Deviation 0.19 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Basophils: Change from week 0 to week 52 | 0 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Thrombocytes: Change from week 0 to week 52 | -7 10^9 cells per liter (10^9/L) | Standard Deviation 39 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Monocytes: Change from week 0 to week 52 | -0.06 10^9 cells per liter (10^9/L) | Standard Deviation 0.22 |
| Part A: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Lymphocytes: Change from week 0 to week 52 | 0.19 10^9 cells per liter (10^9/L) | Standard Deviation 0.7 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Eosinophils: Change from week 0 to week 52 | -0.13 10^9 cells per liter (10^9/L) | Standard Deviation 0.36 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Leukocytes: Change from week 0 to week 52 | -0.7 10^9 cells per liter (10^9/L) | Standard Deviation 2.8 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Thrombocytes: Change from week 0 to week 52 | -2 10^9 cells per liter (10^9/L) | Standard Deviation 37 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Basophils: Change from week 0 to week 52 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Lymphocytes: Change from week 0 to week 52 | -0.47 10^9 cells per liter (10^9/L) | Standard Deviation 0.59 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Neutrophils: Change from week 0 to week 52 | -0.03 10^9 cells per liter (10^9/L) | Standard Deviation 2.03 |
| Part B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Monocytes: Change from week 0 to week 52 | -0.05 10^9 cells per liter (10^9/L) | Standard Deviation 0.19 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Neutrophils: Change from week 0 to week 52 | -0.07 10^9 cells per liter (10^9/L) | Standard Deviation 2.55 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Thrombocytes: Change from week 0 to week 52 | 37 10^9 cells per liter (10^9/L) | Standard Deviation 70 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Leukocytes: Change from week 0 to week 52 | 0.3 10^9 cells per liter (10^9/L) | Standard Deviation 3 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Eosinophils: Change from week 0 to week 52 | -0.17 10^9 cells per liter (10^9/L) | Standard Deviation 0.13 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Basophils: Change from week 0 to week 52 | 0.02 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Lymphocytes: Change from week 0 to week 52 | 0.39 10^9 cells per liter (10^9/L) | Standard Deviation 0.49 |
| Part B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Monocytes: Change from week 0 to week 52 | 0.14 10^9 cells per liter (10^9/L) | Standard Deviation 0.2 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Eosinophils: Change from week 0 to week 52 | -0.05 10^9 cells per liter (10^9/L) | Standard Deviation 0.24 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Leukocytes: Change from week 0 to week 52 | -0.4 10^9 cells per liter (10^9/L) | Standard Deviation 1.9 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Monocytes: Change from week 0 to week 52 | -0.04 10^9 cells per liter (10^9/L) | Standard Deviation 0.19 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Thrombocytes: Change from week 0 to week 52 | 10 10^9 cells per liter (10^9/L) | Standard Deviation 42 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Lymphocytes: Change from week 0 to week 52 | -0.36 10^9 cells per liter (10^9/L) | Standard Deviation 0.63 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Neutrophils: Change from week 0 to week 52 | 0.05 10^9 cells per liter (10^9/L) | Standard Deviation 1.53 |
| Part A+B: Liraglutide | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Basophils: Change from week 0 to week 52 | -0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Monocytes: Change from week 0 to week 52 | 0 10^9 cells per liter (10^9/L) | Standard Deviation 0.23 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Basophils: Change from week 0 to week 52 | 0.01 10^9 cells per liter (10^9/L) | Standard Deviation 0.04 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Eosinophils: Change from week 0 to week 52 | -0.03 10^9 cells per liter (10^9/L) | Standard Deviation 0.2 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Leukocytes: Change from week 0 to week 52 | -0.3 10^9 cells per liter (10^9/L) | Standard Deviation 2.1 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Lymphocytes: Change from week 0 to week 52 | 0.25 10^9 cells per liter (10^9/L) | Standard Deviation 0.63 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Thrombocytes: Change from week 0 to week 52 | 5 10^9 cells per liter (10^9/L) | Standard Deviation 49 |
| Part A+B: Placebo | Change in Haematology: Thrombocytes, Leukocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes, Monocytes From Baseline at Week 52 | Neutrophils: Change from week 0 to week 52 | -0.55 10^9 cells per liter (10^9/L) | Standard Deviation 1.75 |
Secondary
Change in HbA1c From Baseline at Week 52
Change in HbA1c from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in HbA1c From Baseline at Week 52 | -0.2 Percentage point of HbA1c | Standard Deviation 0.2 |
| Part A: Placebo | Change in HbA1c From Baseline at Week 52 | 0.1 Percentage point of HbA1c | Standard Deviation 0.3 |
| Part B: Liraglutide | Change in HbA1c From Baseline at Week 52 | -0.2 Percentage point of HbA1c | Standard Deviation 0.4 |
| Part B: Placebo | Change in HbA1c From Baseline at Week 52 | -0.1 Percentage point of HbA1c | Standard Deviation 0.3 |
| Part A+B: Liraglutide | Change in HbA1c From Baseline at Week 52 | -0.2 Percentage point of HbA1c | Standard Deviation 0.3 |
| Part A+B: Placebo | Change in HbA1c From Baseline at Week 52 | 0.1 Percentage point of HbA1c | Standard Deviation 0.3 |
Secondary
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16
Change in HDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | 0.96 Ratio of HDL-cholesterol | Standard Deviation 0.14 |
| Part A: Placebo | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | 1.00 Ratio of HDL-cholesterol | Standard Deviation 0.2 |
| Part B: Liraglutide | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | 1.01 Ratio of HDL-cholesterol | Standard Deviation 0.14 |
| Part B: Placebo | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | 1.12 Ratio of HDL-cholesterol | Standard Deviation 0.13 |
| Part A+B: Liraglutide | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | 0.98 Ratio of HDL-cholesterol | Standard Deviation 0.14 |
| Part A+B: Placebo | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 16 | 1.04 Ratio of HDL-cholesterol | Standard Deviation 0.19 |
Secondary
Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52
Change in HDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | 0.99 Ratio of HDL-cholesterol | Standard Deviation 0.19 |
| Part A: Placebo | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | 1.02 Ratio of HDL-cholesterol | Standard Deviation 0.17 |
| Part B: Liraglutide | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | 1.06 Ratio of HDL-cholesterol | Standard Deviation 0.16 |
| Part B: Placebo | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | 1.08 Ratio of HDL-cholesterol | Standard Deviation 0.12 |
| Part A+B: Liraglutide | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | 1.02 Ratio of HDL-cholesterol | Standard Deviation 0.18 |
| Part A+B: Placebo | Change in High Density Lipoprotein (HDL)-Cholesterol From Baseline at Week 52 | 1.04 Ratio of HDL-cholesterol | Standard Deviation 0.15 |
Secondary
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16
Change in hsCRP from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | 0.79 Milligram per liter (mg/L) | Standard Deviation 2.58 |
| Part A: Placebo | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | -0.57 Milligram per liter (mg/L) | Standard Deviation 6.61 |
| Part B: Liraglutide | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | -2.79 Milligram per liter (mg/L) | Standard Deviation 8.03 |
| Part B: Placebo | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | 1.87 Milligram per liter (mg/L) | Standard Deviation 2.12 |
| Part A+B: Liraglutide | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | -0.61 Milligram per liter (mg/L) | Standard Deviation 5.57 |
| Part A+B: Placebo | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 16 | 0.24 Milligram per liter (mg/L) | Standard Deviation 5.57 |
Secondary
Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52
Change in hsCRP from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | 0.25 mg/L | Standard Deviation 2.55 |
| Part A: Placebo | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | 0.14 mg/L | Standard Deviation 3.67 |
| Part B: Liraglutide | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | -2.42 mg/L | Standard Deviation 9.19 |
| Part B: Placebo | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | -0.37 mg/L | Standard Deviation 0.84 |
| Part A+B: Liraglutide | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | -0.89 mg/L | Standard Deviation 6.31 |
| Part A+B: Placebo | Change in High Sensitivity C Reactive Protein (hsCRP) From Baseline at Week 52 | -0.03 mg/L | Standard Deviation 2.99 |
Secondary
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16
Change in HOMA-B from baseline to week 16 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin\[mU/L\]/(FPG\[mmol/L\]-3.5).
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | 1.69 Ratio of HOMA-B | Standard Deviation 1.93 |
| Part A: Placebo | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | 0.70 Ratio of HOMA-B | Standard Deviation 0.31 |
| Part B: Liraglutide | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | 1.55 Ratio of HOMA-B | Standard Deviation 1.04 |
| Part B: Placebo | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | 1.07 Ratio of HOMA-B | Standard Deviation 0.51 |
| Part A+B: Liraglutide | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | 1.63 Ratio of HOMA-B | Standard Deviation 1.59 |
| Part A+B: Placebo | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 16 | 0.82 Ratio of HOMA-B | Standard Deviation 0.41 |
Secondary
Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52
Change in HOMA-B from baseline to week 52 is presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin\[mU/L\]/(FPG\[mmol/L\]-3.5).
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | 2.24 Ratio of HOMA-B | Standard Deviation 1.85 |
| Part A: Placebo | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | 0.65 Ratio of HOMA-B | Standard Deviation 0.3 |
| Part B: Liraglutide | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | 1.50 Ratio of HOMA-B | Standard Deviation 1.5 |
| Part B: Placebo | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | 1.25 Ratio of HOMA-B | Standard Deviation 0.5 |
| Part A+B: Liraglutide | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | 1.91 Ratio of HOMA-B | Standard Deviation 1.71 |
| Part A+B: Placebo | Change in Homeostasis Model Assessment of Beta-cell Function (HOMA-B) From Baseline at Week 52 | 0.88 Ratio of HOMA-B | Standard Deviation 0.48 |
Secondary
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16
Change in HOMA-IR from baseline to week 16 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose \[mmol/L\] x fasting insulin \[mmol/L\]/ 22.5.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | 1.57 Ratio of HOMA-IR | Standard Deviation 1.92 |
| Part A: Placebo | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | 0.80 Ratio of HOMA-IR | Standard Deviation 0.35 |
| Part B: Liraglutide | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | 1.43 Ratio of HOMA-IR | Standard Deviation 1.26 |
| Part B: Placebo | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | 1.33 Ratio of HOMA-IR | Standard Deviation 0.82 |
| Part A+B: Liraglutide | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | 1.51 Ratio of HOMA-IR | Standard Deviation 1.65 |
| Part A+B: Placebo | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 16 | 0.97 Ratio of HOMA-IR | Standard Deviation 0.58 |
Secondary
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52
Change in HOMA-IR from baseline to week 52 is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose \[mmol/L\] x fasting insulin \[mmol/L\]/ 22.5.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | 2.26 Ratio of HOMA-IR | Standard Deviation 3.13 |
| Part A: Placebo | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | 0.88 Ratio of HOMA-IR | Standard Deviation 0.5 |
| Part B: Liraglutide | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | 1.45 Ratio of HOMA-IR | Standard Deviation 1.23 |
| Part B: Placebo | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | 1.24 Ratio of HOMA-IR | Standard Deviation 0.48 |
| Part A+B: Liraglutide | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | 1.90 Ratio of HOMA-IR | Standard Deviation 2.46 |
| Part A+B: Placebo | Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Baseline at Week 52 | 1.02 Ratio of HOMA-IR | Standard Deviation 0.51 |
Secondary
Change in Hormone Level: Calcitonin From Baseline at Week 16
Change in calcitonin from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Calcitonin From Baseline at Week 16 | 0 nanogram per liter (ng/L) | Standard Deviation 0 |
| Part A: Placebo | Change in Hormone Level: Calcitonin From Baseline at Week 16 | 0 nanogram per liter (ng/L) | Standard Deviation 0 |
| Part B: Liraglutide | Change in Hormone Level: Calcitonin From Baseline at Week 16 | 0.3 nanogram per liter (ng/L) | Standard Deviation 1.1 |
| Part B: Placebo | Change in Hormone Level: Calcitonin From Baseline at Week 16 | 0 nanogram per liter (ng/L) | Standard Deviation 0 |
| Part A+B: Liraglutide | Change in Hormone Level: Calcitonin From Baseline at Week 16 | 0.1 nanogram per liter (ng/L) | Standard Deviation 0.7 |
| Part A+B: Placebo | Change in Hormone Level: Calcitonin From Baseline at Week 16 | 0 nanogram per liter (ng/L) | Standard Deviation 0 |
Secondary
Change in Hormone Level: Calcitonin From Baseline at Week 52
Change in calcitonin from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Calcitonin From Baseline at Week 52 | 0.1 ng/L | Standard Deviation 0.6 |
| Part A: Placebo | Change in Hormone Level: Calcitonin From Baseline at Week 52 | 0 ng/L | Standard Deviation 0 |
| Part B: Liraglutide | Change in Hormone Level: Calcitonin From Baseline at Week 52 | 0.5 ng/L | Standard Deviation 1.2 |
| Part B: Placebo | Change in Hormone Level: Calcitonin From Baseline at Week 52 | 0 ng/L | Standard Deviation 0 |
| Part A+B: Liraglutide | Change in Hormone Level: Calcitonin From Baseline at Week 52 | 0.3 ng/L | Standard Deviation 0.9 |
| Part A+B: Placebo | Change in Hormone Level: Calcitonin From Baseline at Week 52 | 0 ng/L | Standard Deviation 0 |
Secondary
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16
Change in CEA serum from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | -0.01 nanogram per milliliter (ng/mL) | Standard Deviation 0.11 |
| Part A: Placebo | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | -0.17 nanogram per milliliter (ng/mL) | Standard Deviation 0.3 |
| Part B: Liraglutide | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | 0.17 nanogram per milliliter (ng/mL) | Standard Deviation 0.55 |
| Part B: Placebo | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | -0.04 nanogram per milliliter (ng/mL) | Standard Deviation 0.1 |
| Part A+B: Liraglutide | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | 0.07 nanogram per milliliter (ng/mL) | Standard Deviation 0.38 |
| Part A+B: Placebo | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 16 | -0.12 nanogram per milliliter (ng/mL) | Standard Deviation 0.24 |
Secondary
Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52
Change in CEA serum from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | 0.03 ng/mL | Standard Deviation 0.38 |
| Part A: Placebo | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | -0.14 ng/mL | Standard Deviation 0.26 |
| Part B: Liraglutide | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | -0.01 ng/mL | Standard Deviation 0.14 |
| Part B: Placebo | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | 0.17 ng/mL | Standard Deviation 0.24 |
| Part A+B: Liraglutide | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | 0.01 ng/mL | Standard Deviation 0.29 |
| Part A+B: Placebo | Change in Hormone Level: Carcinoembryonic Antigen (CEA) From Baseline at Week 52 | -0.01 ng/mL | Standard Deviation 0.29 |
Secondary
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16
Change in DHEAS from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | 0.16 umol/L | Standard Deviation 1.74 |
| Part A: Placebo | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | 0.21 umol/L | Standard Deviation 0.95 |
| Part B: Liraglutide | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | 0.25 umol/L | Standard Deviation 1.1 |
| Part B: Placebo | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | 1.00 umol/L | Standard Deviation 1.42 |
| Part A+B: Liraglutide | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | 0.20 umol/L | Standard Deviation 1.48 |
| Part A+B: Placebo | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 16 | 0.46 umol/L | Standard Deviation 1.13 |
Secondary
Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52
Change in DHEAS from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | 0.77 umol/L | Standard Deviation 1.18 |
| Part A: Placebo | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | 0.76 umol/L | Standard Deviation 0.97 |
| Part B: Liraglutide | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | 0.25 umol/L | Standard Deviation 0.66 |
| Part B: Placebo | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | 0.74 umol/L | Standard Deviation 1.26 |
| Part A+B: Liraglutide | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | 0.55 umol/L | Standard Deviation 1.01 |
| Part A+B: Placebo | Change in Hormone Level: Dehydroepiandrosterone Sulfate (DHEAS) From Baseline at Week 52 | 0.76 umol/L | Standard Deviation 1.01 |
Secondary
Change in Hormone Level: Estradiol (Females) From Baseline at Week 16
Change in estradiol (only for females) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of female participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | 0.9 picograms per milliliter (pg/mL) | Standard Deviation 15.8 |
| Part A: Placebo | Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | 9.2 picograms per milliliter (pg/mL) | Standard Deviation 11.9 |
| Part B: Liraglutide | Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | 1.6 picograms per milliliter (pg/mL) | Standard Deviation 3.8 |
| Part B: Placebo | Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | 0 picograms per milliliter (pg/mL) | Standard Deviation 0 |
| Part A+B: Liraglutide | Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | 1.2 picograms per milliliter (pg/mL) | Standard Deviation 12.2 |
| Part A+B: Placebo | Change in Hormone Level: Estradiol (Females) From Baseline at Week 16 | 6.1 picograms per milliliter (pg/mL) | Standard Deviation 10.4 |
Secondary
Change in Hormone Level: Estradiol (Females) From Baseline at Week 52
Change in estradiol (only for females) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of female participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | 7.0 pg/mL | Standard Deviation 32.6 |
| Part A: Placebo | Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | 13.7 pg/mL | Standard Deviation 21.6 |
| Part B: Liraglutide | Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | 1.6 pg/mL | Standard Deviation 4.5 |
| Part B: Placebo | Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | 0 pg/mL | — |
| Part A+B: Liraglutide | Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | 4.1 pg/mL | Standard Deviation 21.8 |
| Part A+B: Placebo | Change in Hormone Level: Estradiol (Females) From Baseline at Week 52 | 11.0 pg/mL | Standard Deviation 19.7 |
Secondary
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16
Change in free T4 and ACTH from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | T4: Change from week 0 to week 16 | -0.6 picomole per liter (pmol/L) | Standard Deviation 1.4 |
| Part A: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | ACTH: Change from week 0 to week 16 | 0.99 picomole per liter (pmol/L) | Standard Deviation 5.22 |
| Part A: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | T4: Change from week 0 to week 16 | 0.3 picomole per liter (pmol/L) | Standard Deviation 1.1 |
| Part A: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | ACTH: Change from week 0 to week 16 | -0.85 picomole per liter (pmol/L) | Standard Deviation 2.22 |
| Part B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | T4: Change from week 0 to week 16 | 0.7 picomole per liter (pmol/L) | Standard Deviation 2.3 |
| Part B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | ACTH: Change from week 0 to week 16 | -0.37 picomole per liter (pmol/L) | Standard Deviation 1.49 |
| Part B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | T4: Change from week 0 to week 16 | 0.1 picomole per liter (pmol/L) | Standard Deviation 1.7 |
| Part B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | ACTH: Change from week 0 to week 16 | -1.32 picomole per liter (pmol/L) | Standard Deviation 1.87 |
| Part A+B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | T4: Change from week 0 to week 16 | -0.1 picomole per liter (pmol/L) | Standard Deviation 1.9 |
| Part A+B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | ACTH: Change from week 0 to week 16 | 0.42 picomole per liter (pmol/L) | Standard Deviation 4.1 |
| Part A+B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | T4: Change from week 0 to week 16 | 0.2 picomole per liter (pmol/L) | Standard Deviation 1.3 |
| Part A+B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 16 | ACTH: Change from week 0 to week 16 | -1.02 picomole per liter (pmol/L) | Standard Deviation 2.04 |
Secondary
Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52
Change in free T4 and ACTH from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | T4: Change from week 0 to week 52 | -0.4 pmol/L | Standard Deviation 1.7 |
| Part A: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | ACTH: Change from week 0 to week 52 | -0.02 pmol/L | Standard Deviation 2.02 |
| Part A: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | T4: Change from week 0 to week 52 | 1.9 pmol/L | Standard Deviation 2.7 |
| Part A: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | ACTH: Change from week 0 to week 52 | 1.29 pmol/L | Standard Deviation 3.5 |
| Part B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | T4: Change from week 0 to week 52 | -0.1 pmol/L | Standard Deviation 2 |
| Part B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | ACTH: Change from week 0 to week 52 | 0.98 pmol/L | Standard Deviation 5.64 |
| Part B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | T4: Change from week 0 to week 52 | 0.8 pmol/L | Standard Deviation 2.3 |
| Part B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | ACTH: Change from week 0 to week 52 | 0.20 pmol/L | Standard Deviation 2.41 |
| Part A+B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | T4: Change from week 0 to week 52 | -0.3 pmol/L | Standard Deviation 1.8 |
| Part A+B: Liraglutide | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | ACTH: Change from week 0 to week 52 | 0.42 pmol/L | Standard Deviation 3.99 |
| Part A+B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | T4: Change from week 0 to week 52 | 1.5 pmol/L | Standard Deviation 2.5 |
| Part A+B: Placebo | Change in Hormone Level: Free Thyroxine (Free T4) and Adrenocorticotropic Hormone (ACTH) From Baseline at Week 52 | ACTH: Change from week 0 to week 52 | 0.89 pmol/L | Standard Deviation 3.07 |
Secondary
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16
Change in IGF-1 and cortisol from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | IGF-1: Change from week 0 to week 16 | -56.89 nanogram per milliliter (ng/mL) | Standard Deviation 126.46 |
| Part A: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Cortisol: Change from week 0 to week 16 | -22.94 nanogram per milliliter (ng/mL) | Standard Deviation 41.36 |
| Part A: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | IGF-1: Change from week 0 to week 16 | -28.23 nanogram per milliliter (ng/mL) | Standard Deviation 95.79 |
| Part A: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Cortisol: Change from week 0 to week 16 | 6.75 nanogram per milliliter (ng/mL) | Standard Deviation 38.72 |
| Part B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | IGF-1: Change from week 0 to week 16 | 2.41 nanogram per milliliter (ng/mL) | Standard Deviation 84.98 |
| Part B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Cortisol: Change from week 0 to week 16 | -8.09 nanogram per milliliter (ng/mL) | Standard Deviation 22.98 |
| Part B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | IGF-1: Change from week 0 to week 16 | -14.23 nanogram per milliliter (ng/mL) | Standard Deviation 75.01 |
| Part B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Cortisol: Change from week 0 to week 16 | -23.08 nanogram per milliliter (ng/mL) | Standard Deviation 59.02 |
| Part A+B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | IGF-1: Change from week 0 to week 16 | -30.31 nanogram per milliliter (ng/mL) | Standard Deviation 112.09 |
| Part A+B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Cortisol: Change from week 0 to week 16 | -16.71 nanogram per milliliter (ng/mL) | Standard Deviation 35.16 |
| Part A+B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | IGF-1: Change from week 0 to week 16 | -23.86 nanogram per milliliter (ng/mL) | Standard Deviation 87.54 |
| Part A+B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 16 | Cortisol: Change from week 0 to week 16 | -4.85 nanogram per milliliter (ng/mL) | Standard Deviation 48.33 |
Secondary
Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52
Change in IGF-1 and cortisol from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | IGF-1: Change from week 0 to week 52 | -25.90 ng/mL | Standard Deviation 195.61 |
| Part A: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Cortisol: Change from week 0 to week 52 | 3.60 ng/mL | Standard Deviation 50.63 |
| Part A: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | IGF-1: Change from week 0 to week 52 | -103.45 ng/mL | Standard Deviation 136.61 |
| Part A: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Cortisol: Change from week 0 to week 52 | 7.54 ng/mL | Standard Deviation 33.71 |
| Part B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | IGF-1: Change from week 0 to week 52 | -1.47 ng/mL | Standard Deviation 112.93 |
| Part B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Cortisol: Change from week 0 to week 52 | -14.15 ng/mL | Standard Deviation 43.84 |
| Part B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | IGF-1: Change from week 0 to week 52 | 10.40 ng/mL | Standard Deviation 56.69 |
| Part B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Cortisol: Change from week 0 to week 52 | 21.67 ng/mL | Standard Deviation 46.62 |
| Part A+B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | IGF-1: Change from week 0 to week 52 | -15.04 ng/mL | Standard Deviation 161.72 |
| Part A+B: Liraglutide | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Cortisol: Change from week 0 to week 52 | -4.01 ng/mL | Standard Deviation 47.82 |
| Part A+B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | IGF-1: Change from week 0 to week 52 | -59.66 ng/mL | Standard Deviation 123.62 |
| Part A+B: Placebo | Change in Hormone Level: Insulin-like Growth Factor-1 (IGF-1) and Cortisol From Baseline at Week 52 | Cortisol: Change from week 0 to week 52 | 12.59 ng/mL | Standard Deviation 37.65 |
Secondary
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16
Change in LH and FSH from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | LH: Change from week 0 to week 16 | -0.04 IU/L | Standard Deviation 1.28 |
| Part A: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | FSH: Change from week 0 to week 16 | -0.2 IU/L | Standard Deviation 2.5 |
| Part A: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | LH: Change from week 0 to week 16 | 0.06 IU/L | Standard Deviation 0.74 |
| Part A: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | FSH: Change from week 0 to week 16 | 0.2 IU/L | Standard Deviation 1 |
| Part B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | LH: Change from week 0 to week 16 | -0.07 IU/L | Standard Deviation 0.25 |
| Part B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | FSH: Change from week 0 to week 16 | -0.1 IU/L | Standard Deviation 1.3 |
| Part B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | LH: Change from week 0 to week 16 | 0.22 IU/L | Standard Deviation 0.42 |
| Part B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | FSH: Change from week 0 to week 16 | 1.0 IU/L | Standard Deviation 1.1 |
| Part A+B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | LH: Change from week 0 to week 16 | -0.05 IU/L | Standard Deviation 0.97 |
| Part A+B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | FSH: Change from week 0 to week 16 | -0.2 IU/L | Standard Deviation 2.1 |
| Part A+B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | LH: Change from week 0 to week 16 | 0.12 IU/L | Standard Deviation 0.63 |
| Part A+B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 16 | FSH: Change from week 0 to week 16 | 0.5 IU/L | Standard Deviation 1.1 |
Secondary
Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52
Change in LH and FSH from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | LH: Change from week 0 to week 52 | 0.16 IU/L | Standard Deviation 2.33 |
| Part A: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | FSH: Change from week 0 to week 52 | 1.1 IU/L | Standard Deviation 3.9 |
| Part A: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | LH: Change from week 0 to week 52 | 0.06 IU/L | Standard Deviation 0.79 |
| Part A: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | FSH: Change from week 0 to week 52 | 0.4 IU/L | Standard Deviation 1.6 |
| Part B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | LH: Change from week 0 to week 52 | 0.37 IU/L | Standard Deviation 0.96 |
| Part B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | FSH: Change from week 0 to week 52 | 0.4 IU/L | Standard Deviation 1.8 |
| Part B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | LH: Change from week 0 to week 52 | 0.30 IU/L | Standard Deviation 0.51 |
| Part B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | FSH: Change from week 0 to week 52 | 0.7 IU/L | Standard Deviation 1.6 |
| Part A+B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | LH: Change from week 0 to week 52 | 0.24 IU/L | Standard Deviation 1.87 |
| Part A+B: Liraglutide | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | FSH: Change from week 0 to week 52 | 0.8 IU/L | Standard Deviation 3.1 |
| Part A+B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | LH: Change from week 0 to week 52 | 0.14 IU/L | Standard Deviation 0.7 |
| Part A+B: Placebo | Change in Hormone Level: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH) From Baseline at Week 52 | FSH: Change from week 0 to week 52 | 0.6 IU/L | Standard Deviation 1.5 |
Secondary
Change in Hormone Level: Testosterone (Males) From Baseline at Week 16
Change in testosterone (only for males) from baseline to week 16 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of male participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Testosterone (Males) From Baseline at Week 16 | 1.55 nanomoles per liter (nmol/L) | Standard Deviation 2.01 |
| Part A: Placebo | Change in Hormone Level: Testosterone (Males) From Baseline at Week 16 | 0.61 nanomoles per liter (nmol/L) | Standard Deviation 1.66 |
Secondary
Change in Hormone Level: Testosterone (Males) From Baseline at Week 52
Change in testosterone (only for males) from baseline to week 52 is presented. The testosterone analysis for Part B could not be performed due to an unforeseen change in the assay used by the central laboratory to measure testosterone during the trial. This change in methodology prevented a direct comparison of values measured at different time points during the trial.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of male participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Testosterone (Males) From Baseline at Week 52 | 0.62 nmol/L | Standard Deviation 1.4 |
| Part A: Placebo | Change in Hormone Level: Testosterone (Males) From Baseline at Week 52 | -0.34 nmol/L | Standard Deviation 1.51 |
Secondary
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16
Change in TSH and prolactin from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | TSH: Change from week 0 to week 16 | -0.34 Milli-international units/liter (mIU/L) | Standard Deviation 0.68 |
| Part A: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Prolactin: Change from week 0 to week 16 | 7 Milli-international units/liter (mIU/L) | Standard Deviation 27 |
| Part A: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | TSH: Change from week 0 to week 16 | -0.01 Milli-international units/liter (mIU/L) | Standard Deviation 0.72 |
| Part A: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Prolactin: Change from week 0 to week 16 | -6 Milli-international units/liter (mIU/L) | Standard Deviation 33 |
| Part B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | TSH: Change from week 0 to week 16 | -0.09 Milli-international units/liter (mIU/L) | Standard Deviation 1.13 |
| Part B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Prolactin: Change from week 0 to week 16 | 0 Milli-international units/liter (mIU/L) | Standard Deviation 13 |
| Part B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | TSH: Change from week 0 to week 16 | -0.59 Milli-international units/liter (mIU/L) | Standard Deviation 0.67 |
| Part B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Prolactin: Change from week 0 to week 16 | -22 Milli-international units/liter (mIU/L) | Standard Deviation 63 |
| Part A+B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | TSH: Change from week 0 to week 16 | -0.23 Milli-international units/liter (mIU/L) | Standard Deviation 0.89 |
| Part A+B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Prolactin: Change from week 0 to week 16 | 4 Milli-international units/liter (mIU/L) | Standard Deviation 22 |
| Part A+B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | TSH: Change from week 0 to week 16 | -0.23 Milli-international units/liter (mIU/L) | Standard Deviation 0.74 |
| Part A+B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 16 | Prolactin: Change from week 0 to week 16 | -12 Milli-international units/liter (mIU/L) | Standard Deviation 45 |
Secondary
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52
Change in TSH and prolactin from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | TSH: Change from week 0 to week 52 | 0.02 mIU/L | Standard Deviation 1.59 |
| Part A: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Prolactin: Change from week 0 to week 52 | 10 mIU/L | Standard Deviation 38 |
| Part A: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | TSH: Change from week 0 to week 52 | -0.48 mIU/L | Standard Deviation 0.63 |
| Part A: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Prolactin: Change from week 0 to week 52 | 8 mIU/L | Standard Deviation 37 |
| Part B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | TSH: Change from week 0 to week 52 | -0.75 mIU/L | Standard Deviation 2.13 |
| Part B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Prolactin: Change from week 0 to week 52 | -3 mIU/L | Standard Deviation 37 |
| Part B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | TSH: Change from week 0 to week 52 | -0.17 mIU/L | Standard Deviation 1.08 |
| Part B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Prolactin: Change from week 0 to week 52 | 29 mIU/L | Standard Deviation 33 |
| Part A+B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | TSH: Change from week 0 to week 52 | -0.30 mIU/L | Standard Deviation 1.83 |
| Part A+B: Liraglutide | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Prolactin: Change from week 0 to week 52 | 5 mIU/L | Standard Deviation 37 |
| Part A+B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | TSH: Change from week 0 to week 52 | -0.38 mIU/L | Standard Deviation 0.78 |
| Part A+B: Placebo | Change in Hormone Level: Thyroid Stimulating Hormone (TSH) and Prolactin From Baseline at Week 52 | Prolactin: Change from week 0 to week 52 | 15 mIU/L | Standard Deviation 36 |
Secondary
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16
Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 16 is presented. The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia drive score | -0.9 Score on a scale | Standard Deviation 2.8 |
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia behaviour score | -0.8 Score on a scale | Standard Deviation 2.01 |
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia total score | -2.4 Score on a scale | Standard Deviation 5.55 |
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia severity score | -0.6 Score on a scale | Standard Deviation 1.54 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia behaviour score | -1.7 Score on a scale | Standard Deviation 4.14 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia total score | -2.9 Score on a scale | Standard Deviation 5.79 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia drive score | -0.9 Score on a scale | Standard Deviation 2.61 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia severity score | -0.3 Score on a scale | Standard Deviation 2.46 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia severity score | -0.1 Score on a scale | Standard Deviation 1.65 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia drive score | -1.8 Score on a scale | Standard Deviation 2.97 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia total score | -3.1 Score on a scale | Standard Deviation 7.28 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia behaviour score | -1.2 Score on a scale | Standard Deviation 3.83 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia behaviour score | -2.6 Score on a scale | Standard Deviation 2.07 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia severity score | 0.1 Score on a scale | Standard Deviation 1.46 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia drive score | -2.0 Score on a scale | Standard Deviation 2.89 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia total score | -4.4 Score on a scale | Standard Deviation 5.65 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia drive score | -1.3 Score on a scale | Standard Deviation 2.87 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia behaviour score | -1.0 Score on a scale | Standard Deviation 2.97 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia severity score | -0.4 Score on a scale | Standard Deviation 1.59 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia total score | -2.7 Score on a scale | Standard Deviation 6.34 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia drive score | -1.3 Score on a scale | Standard Deviation 2.69 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia behaviour score | -2.0 Score on a scale | Standard Deviation 3.48 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia total score | -3.5 Score on a scale | Standard Deviation 5.63 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 16 | Hyperphagia severity score | -0.2 Score on a scale | Standard Deviation 2.12 |
Secondary
Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52
Change in hyperphagia score (hyperphagia total score and hyperphagic behaviour, drive and severity score respectively), from baseline to week 52 is presented.The Hyperphagia Questionnaire (HQ)- Total Score. It contains 11 questions which are categorised into 3 subscales; Hyperphagic Behaviour, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. The HQ-Behaviour Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviours and a worse outcome. The HQ- Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome. The HQ- Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia behaviour score | -0.9 Score on a scale | Standard Deviation 3.2 |
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia drive score | -2.2 Score on a scale | Standard Deviation 2.9 |
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia severity score | -1.3 Score on a scale | Standard Deviation 1.81 |
| Part A: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia total score | -4.4 Score on a scale | Standard Deviation 6.57 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia severity score | -0.9 Score on a scale | Standard Deviation 2.51 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia drive score | -0.5 Score on a scale | Standard Deviation 2.42 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia behaviour score | -0.6 Score on a scale | Standard Deviation 2.62 |
| Part A: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia total score | -2.1 Score on a scale | Standard Deviation 6.11 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia total score | -2.1 Score on a scale | Standard Deviation 10.11 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia severity score | -0.4 Score on a scale | Standard Deviation 2.73 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia drive score | -1.1 Score on a scale | Standard Deviation 3.99 |
| Part B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia behaviour score | -0.7 Score on a scale | Standard Deviation 4.63 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia behaviour score | -2.6 Score on a scale | Standard Deviation 3.65 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia total score | -5.4 Score on a scale | Standard Deviation 8.32 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia drive score | -1.4 Score on a scale | Standard Deviation 4.45 |
| Part B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia severity score | -1.4 Score on a scale | Standard Deviation 1.82 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia severity score | -0.9 Score on a scale | Standard Deviation 2.27 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia total score | -3.4 Score on a scale | Standard Deviation 8.23 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia drive score | -1.7 Score on a scale | Standard Deviation 3.41 |
| Part A+B: Liraglutide | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia behaviour score | -0.8 Score on a scale | Standard Deviation 3.82 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia drive score | -0.8 Score on a scale | Standard Deviation 3.06 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia severity score | -1.1 Score on a scale | Standard Deviation 2.26 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia total score | -3.1 Score on a scale | Standard Deviation 6.77 |
| Part A+B: Placebo | Change in Hyperphagia Score: Total Score and Hyperphagic Behaviour, Drive and Severity Score From Baseline at Week 52 | Hyperphagia behaviour score | -1.3 Score on a scale | Standard Deviation 3 |
Secondary
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16
Change in LDL-cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | 1.01 Ratio of LDL-cholesterol | Standard Deviation 0.15 |
| Part A: Placebo | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | 1.13 Ratio of LDL-cholesterol | Standard Deviation 0.19 |
| Part B: Liraglutide | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | 1.04 Ratio of LDL-cholesterol | Standard Deviation 0.17 |
| Part B: Placebo | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | 0.96 Ratio of LDL-cholesterol | Standard Deviation 0.14 |
| Part A+B: Liraglutide | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | 1.02 Ratio of LDL-cholesterol | Standard Deviation 0.16 |
| Part A+B: Placebo | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 16 | 1.07 Ratio of LDL-cholesterol | Standard Deviation 0.19 |
Secondary
Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52
Change in LDL-cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | 1.02 Ratio of LDL-cholesterol | Standard Deviation 0.22 |
| Part A: Placebo | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | 1.12 Ratio of LDL-cholesterol | Standard Deviation 0.23 |
| Part B: Liraglutide | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | 0.99 Ratio of LDL-cholesterol | Standard Deviation 0.19 |
| Part B: Placebo | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | 1.06 Ratio of LDL-cholesterol | Standard Deviation 0.1 |
| Part A+B: Liraglutide | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | 1.01 Ratio of LDL-cholesterol | Standard Deviation 0.2 |
| Part A+B: Placebo | Change in Low Density Lipoprotein (LDL)-Cholesterol From Baseline at Week 52 | 1.10 Ratio of LDL-cholesterol | Standard Deviation 0.19 |
Secondary
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16
Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | 1.02 Ratio of non-HDL cholesterol | Standard Deviation 0.16 |
| Part A: Placebo | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | 1.09 Ratio of non-HDL cholesterol | Standard Deviation 0.15 |
| Part B: Liraglutide | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | 1.03 Ratio of non-HDL cholesterol | Standard Deviation 0.16 |
| Part B: Placebo | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | 0.93 Ratio of non-HDL cholesterol | Standard Deviation 0.12 |
| Part A+B: Liraglutide | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | 1.02 Ratio of non-HDL cholesterol | Standard Deviation 0.15 |
| Part A+B: Placebo | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 16 | 1.04 Ratio of non-HDL cholesterol | Standard Deviation 0.16 |
Secondary
Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52
Change in non-HDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | 1.02 Ratio of non-HDL cholesterol | Standard Deviation 0.22 |
| Part A: Placebo | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | 1.07 Ratio of non-HDL cholesterol | Standard Deviation 0.19 |
| Part B: Liraglutide | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | 1.00 Ratio of non-HDL cholesterol | Standard Deviation 0.16 |
| Part B: Placebo | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | 1.07 Ratio of non-HDL cholesterol | Standard Deviation 0.13 |
| Part A+B: Liraglutide | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | 1.01 Ratio of non-HDL cholesterol | Standard Deviation 0.19 |
| Part A+B: Placebo | Change in Non-high Density Lipoprotein (Non-HDL) Cholesterol From Baseline at Week 52 | 1.07 Ratio of non-HDL cholesterol | Standard Deviation 0.17 |
Secondary
Change in Pulse From Baseline at Week 16
Change in pulse from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Pulse From Baseline at Week 16 | 2 Beats/minute | Standard Deviation 12 |
| Part A: Placebo | Change in Pulse From Baseline at Week 16 | -2 Beats/minute | Standard Deviation 5 |
| Part B: Liraglutide | Change in Pulse From Baseline at Week 16 | 1 Beats/minute | Standard Deviation 16 |
| Part B: Placebo | Change in Pulse From Baseline at Week 16 | -9 Beats/minute | Standard Deviation 10 |
| Part A+B: Liraglutide | Change in Pulse From Baseline at Week 16 | 2 Beats/minute | Standard Deviation 14 |
| Part A+B: Placebo | Change in Pulse From Baseline at Week 16 | -4 Beats/minute | Standard Deviation 8 |
Secondary
Change in Pulse From Baseline at Week 52
Change in pulse from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Pulse From Baseline at Week 52 | 1 Beats/minute | Standard Deviation 13 |
| Part A: Placebo | Change in Pulse From Baseline at Week 52 | -8 Beats/minute | Standard Deviation 10 |
| Part B: Liraglutide | Change in Pulse From Baseline at Week 52 | 10 Beats/minute | Standard Deviation 11 |
| Part B: Placebo | Change in Pulse From Baseline at Week 52 | -6 Beats/minute | Standard Deviation 8 |
| Part A+B: Liraglutide | Change in Pulse From Baseline at Week 52 | 5 Beats/minute | Standard Deviation 13 |
| Part A+B: Placebo | Change in Pulse From Baseline at Week 52 | -7 Beats/minute | Standard Deviation 10 |
Secondary
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | SBP: Change from week 0 to week 16 | -5 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Part A: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | DBP: Change from week 0 to week 16 | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Part A: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | SBP: Change from week 0 to week 16 | -2 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Part A: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | DBP: Change from week 0 to week 16 | 0 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Part B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | SBP: Change from week 0 to week 16 | 2 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Part B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | DBP: Change from week 0 to week 16 | 1 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Part B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | SBP: Change from week 0 to week 16 | 2 Millimeters of mercury (mmHg) | Standard Deviation 6 |
| Part B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | DBP: Change from week 0 to week 16 | -1 Millimeters of mercury (mmHg) | Standard Deviation 17 |
| Part A+B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | SBP: Change from week 0 to week 16 | -1 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Part A+B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | DBP: Change from week 0 to week 16 | 0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Part A+B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | SBP: Change from week 0 to week 16 | -1 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| Part A+B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 16 | DBP: Change from week 0 to week 16 | 0 Millimeters of mercury (mmHg) | Standard Deviation 11 |
Secondary
Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | SBP: Change from week 0 to week 52 | -5 Millimeters of mercury (mmHg) | Standard Deviation 6 |
| Part A: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | DBP: Change from week 0 to week 52 | -3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Part A: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | SBP: Change from week 0 to week 52 | 4 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| Part A: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | DBP: Change from week 0 to week 52 | 5 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Part B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | SBP: Change from week 0 to week 52 | 4 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Part B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | DBP: Change from week 0 to week 52 | 4 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Part B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | SBP: Change from week 0 to week 52 | 7 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Part B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | DBP: Change from week 0 to week 52 | 1 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Part A+B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | SBP: Change from week 0 to week 52 | -1 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| Part A+B: Liraglutide | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | DBP: Change from week 0 to week 52 | 0 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| Part A+B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | SBP: Change from week 0 to week 52 | 5 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| Part A+B: Placebo | Change in Systolic and Diastolic Blood Pressure From Baseline at Week 52 | DBP: Change from week 0 to week 52 | 4 Millimeters of mercury (mmHg) | Standard Deviation 12 |
Secondary
Change in Total Cholesterol From Baseline at Week 16
Change in Total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Total Cholesterol From Baseline at Week 16 | 0.99 Ratio of total cholesterol | Standard Deviation 0.1 |
| Part A: Placebo | Change in Total Cholesterol From Baseline at Week 16 | 1.06 Ratio of total cholesterol | Standard Deviation 0.14 |
| Part B: Liraglutide | Change in Total Cholesterol From Baseline at Week 16 | 1.02 Ratio of total cholesterol | Standard Deviation 0.11 |
| Part B: Placebo | Change in Total Cholesterol From Baseline at Week 16 | 0.97 Ratio of total cholesterol | Standard Deviation 0.1 |
| Part A+B: Liraglutide | Change in Total Cholesterol From Baseline at Week 16 | 1.00 Ratio of total cholesterol | Standard Deviation 0.1 |
| Part A+B: Placebo | Change in Total Cholesterol From Baseline at Week 16 | 1.03 Ratio of total cholesterol | Standard Deviation 0.14 |
Secondary
Change in Total Cholesterol From Baseline at Week 52
Change in total cholesterol (measured as millimoles per liter (mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Total Cholesterol From Baseline at Week 52 | 1.00 Ratio of total cholesterol | Standard Deviation 0.18 |
| Part A: Placebo | Change in Total Cholesterol From Baseline at Week 52 | 1.06 Ratio of total cholesterol | Standard Deviation 0.15 |
| Part B: Liraglutide | Change in Total Cholesterol From Baseline at Week 52 | 1.01 Ratio of total cholesterol | Standard Deviation 0.12 |
| Part B: Placebo | Change in Total Cholesterol From Baseline at Week 52 | 1.07 Ratio of total cholesterol | Standard Deviation 0.07 |
| Part A+B: Liraglutide | Change in Total Cholesterol From Baseline at Week 52 | 1.01 Ratio of total cholesterol | Standard Deviation 0.15 |
| Part A+B: Placebo | Change in Total Cholesterol From Baseline at Week 52 | 1.06 Ratio of total cholesterol | Standard Deviation 0.13 |
Secondary
Change in Triglycerides From Baseline at Week 16
Change in triglycerides (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Triglycerides From Baseline at Week 16 | 1.04 Ratio of triglycerides | Standard Deviation 0.36 |
| Part A: Placebo | Change in Triglycerides From Baseline at Week 16 | 0.99 Ratio of triglycerides | Standard Deviation 0.26 |
| Part B: Liraglutide | Change in Triglycerides From Baseline at Week 16 | 1.05 Ratio of triglycerides | Standard Deviation 0.44 |
| Part B: Placebo | Change in Triglycerides From Baseline at Week 16 | 0.80 Ratio of triglycerides | Standard Deviation 0.18 |
| Part A+B: Liraglutide | Change in Triglycerides From Baseline at Week 16 | 1.05 Ratio of triglycerides | Standard Deviation 0.39 |
| Part A+B: Placebo | Change in Triglycerides From Baseline at Week 16 | 0.93 Ratio of triglycerides | Standard Deviation 0.25 |
Secondary
Change in Triglycerides From Baseline at Week 52
Change in triglycerides (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Triglycerides From Baseline at Week 52 | 1.07 Ratio of triglycerides | Standard Deviation 0.36 |
| Part A: Placebo | Change in Triglycerides From Baseline at Week 52 | 0.94 Ratio of triglycerides | Standard Deviation 0.36 |
| Part B: Liraglutide | Change in Triglycerides From Baseline at Week 52 | 1.04 Ratio of triglycerides | Standard Deviation 0.29 |
| Part B: Placebo | Change in Triglycerides From Baseline at Week 52 | 1.12 Ratio of triglycerides | Standard Deviation 0.32 |
| Part A+B: Liraglutide | Change in Triglycerides From Baseline at Week 52 | 1.06 Ratio of triglycerides | Standard Deviation 0.32 |
| Part A+B: Placebo | Change in Triglycerides From Baseline at Week 52 | 1.00 Ratio of triglycerides | Standard Deviation 0.35 |
Secondary
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16
Change in VLDL cholesterol (measured as mmol/L) from baseline to week 16 is presented as ratio to baseline.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | 1.05 Ratio of VLDL cholesterol | Standard Deviation 0.36 |
| Part A: Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | 0.98 Ratio of VLDL cholesterol | Standard Deviation 0.27 |
| Part B: Liraglutide | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | 1.05 Ratio of VLDL cholesterol | Standard Deviation 0.46 |
| Part B: Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | 0.80 Ratio of VLDL cholesterol | Standard Deviation 0.17 |
| Part A+B: Liraglutide | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | 1.05 Ratio of VLDL cholesterol | Standard Deviation 0.4 |
| Part A+B: Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 16 | 0.93 Ratio of VLDL cholesterol | Standard Deviation 0.25 |
Secondary
Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52
Change in VLDL cholesterol (measured as mmol/L) from baseline to week 52 is presented as ratio to baseline.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | 1.06 Ratio of VLDL cholesterol | Standard Deviation 0.35 |
| Part A: Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | 0.95 Ratio of VLDL cholesterol | Standard Deviation 0.36 |
| Part B: Liraglutide | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | 1.03 Ratio of VLDL cholesterol | Standard Deviation 0.26 |
| Part B: Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | 1.13 Ratio of VLDL cholesterol | Standard Deviation 0.31 |
| Part A+B: Liraglutide | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | 1.04 Ratio of VLDL cholesterol | Standard Deviation 0.31 |
| Part A+B: Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol From Baseline at Week 52 | 1.01 Ratio of VLDL cholesterol | Standard Deviation 0.34 |
Secondary
Change in Waist Circumference From Baseline at Week 16
Change in waist circumference from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Waist Circumference From Baseline at Week 16 | -2.50 centimeters (cm) | Standard Deviation 4.52 |
| Part A: Placebo | Change in Waist Circumference From Baseline at Week 16 | -2.44 centimeters (cm) | Standard Deviation 7.84 |
| Part B: Liraglutide | Change in Waist Circumference From Baseline at Week 16 | -0.73 centimeters (cm) | Standard Deviation 6.14 |
| Part B: Placebo | Change in Waist Circumference From Baseline at Week 16 | -1.04 centimeters (cm) | Standard Deviation 4.53 |
| Part A+B: Liraglutide | Change in Waist Circumference From Baseline at Week 16 | -1.70 centimeters (cm) | Standard Deviation 5.31 |
| Part A+B: Placebo | Change in Waist Circumference From Baseline at Week 16 | -1.92 centimeters (cm) | Standard Deviation 6.7 |
Secondary
Change in Waist Circumference From Baseline at Week 52
Change in waist circumference from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Waist Circumference From Baseline at Week 52 | -2.98 centimeter | Standard Deviation 8.68 |
| Part A: Placebo | Change in Waist Circumference From Baseline at Week 52 | -3.48 centimeter | Standard Deviation 7.32 |
| Part B: Liraglutide | Change in Waist Circumference From Baseline at Week 52 | 0.45 centimeter | Standard Deviation 8.05 |
| Part B: Placebo | Change in Waist Circumference From Baseline at Week 52 | 0.97 centimeter | Standard Deviation 5.99 |
| Part A+B: Liraglutide | Change in Waist Circumference From Baseline at Week 52 | -1.49 centimeter | Standard Deviation 8.45 |
| Part A+B: Placebo | Change in Waist Circumference From Baseline at Week 52 | -2.09 centimeter | Standard Deviation 7.06 |
Secondary
Change in Waist-to-hip Circumference Ratio From Baseline at Week 16
Change in waist-to-hip circumference ratio from baseline to week 16 is presented.
Time frame: Week 0, week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | -0.01 Waist-to-hip circumference ratio | Standard Deviation 0.04 |
| Part A: Placebo | Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | -0.02 Waist-to-hip circumference ratio | Standard Deviation 0.06 |
| Part B: Liraglutide | Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | 0.00 Waist-to-hip circumference ratio | Standard Deviation 0.06 |
| Part B: Placebo | Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | 0.01 Waist-to-hip circumference ratio | Standard Deviation 0.04 |
| Part A+B: Liraglutide | Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | -0.01 Waist-to-hip circumference ratio | Standard Deviation 0.05 |
| Part A+B: Placebo | Change in Waist-to-hip Circumference Ratio From Baseline at Week 16 | -0.01 Waist-to-hip circumference ratio | Standard Deviation 0.05 |
Secondary
Change in Waist-to-hip Circumference Ratio From Baseline at Week 52
Change in waist-to-hip circumference ratio from baseline to week 52 is presented.
Time frame: Week 0, week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | -0.01 waist-to-hip circumference ratio | Standard Deviation 0.06 |
| Part A: Placebo | Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | -0.04 waist-to-hip circumference ratio | Standard Deviation 0.06 |
| Part B: Liraglutide | Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | -0.02 waist-to-hip circumference ratio | Standard Deviation 0.05 |
| Part B: Placebo | Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | -0.01 waist-to-hip circumference ratio | Standard Deviation 0.07 |
| Part A+B: Liraglutide | Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | -0.02 waist-to-hip circumference ratio | Standard Deviation 0.06 |
| Part A+B: Placebo | Change in Waist-to-hip Circumference Ratio From Baseline at Week 52 | -0.03 waist-to-hip circumference ratio | Standard Deviation 0.06 |
Secondary
Height Velocity at Week 16
Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Weeks 16 is presented.
Time frame: Week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Height Velocity at Week 16 | 2.113 Centimeters/year (cm/yr) | Standard Deviation 3.084 |
| Part A: Placebo | Height Velocity at Week 16 | 2.718 Centimeters/year (cm/yr) | Standard Deviation 4.281 |
| Part B: Liraglutide | Height Velocity at Week 16 | 4.190 Centimeters/year (cm/yr) | Standard Deviation 2.604 |
| Part B: Placebo | Height Velocity at Week 16 | 6.898 Centimeters/year (cm/yr) | Standard Deviation 2.886 |
| Part A+B: Liraglutide | Height Velocity at Week 16 | 3.090 Centimeters/year (cm/yr) | Standard Deviation 3.014 |
| Part A+B: Placebo | Height Velocity at Week 16 | 4.258 Centimeters/year (cm/yr) | Standard Deviation 4.274 |
Secondary
Height Velocity at Week 52
Height velocity was the change in height per year. The height velocity was calculated as the difference between current height and baseline divided by by time duration in days between those measurement time points and multiplied by 365 days. Height velocity calculated at Week 52 are presented.
Time frame: week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Height Velocity at Week 52 | 1.564 Centimeters/year (cm/yr) | Standard Deviation 1.285 |
| Part A: Placebo | Height Velocity at Week 52 | 1.839 Centimeters/year (cm/yr) | Standard Deviation 1.658 |
| Part B: Liraglutide | Height Velocity at Week 52 | 4.752 Centimeters/year (cm/yr) | Standard Deviation 2.25 |
| Part B: Placebo | Height Velocity at Week 52 | 5.620 Centimeters/year (cm/yr) | Standard Deviation 1.69 |
| Part A+B: Liraglutide | Height Velocity at Week 52 | 3.004 Centimeters/year (cm/yr) | Standard Deviation 2.383 |
| Part A+B: Placebo | Height Velocity at Week 52 | 3.173 Centimeters/year (cm/yr) | Standard Deviation 2.466 |
Secondary
Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia
Symptomatic blood glucose confirmed hypoglycaemia: An episode that is blood glucose confirmed by plasma glucose value \< 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).
Time frame: From week 0 to week 54
Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Liraglutide | Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | 0 Episodes |
| Part A: Placebo | Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | 0 Episodes |
| Part B: Liraglutide | Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | 0 Episodes |
| Part B: Placebo | Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | 0 Episodes |
| Part A+B: Liraglutide | Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | 0 Episodes |
| Part A+B: Placebo | Number of Blood Glucose Confirmed Symptomatic Episodes of Hypoglycaemia | 0 Episodes |
Secondary
Number of Participants in Glycaemic Category at Week 16
Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 16 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG \<5.6 mmol/L (\<100 mg/dL) and/or HbA1c \<5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.
Time frame: week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Pre-diabetes | 2 Participants |
| Part A: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Normoglycaemia | 16 Participants |
| Part A: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Type 2 diabetes | 0 Participants |
| Part A: Placebo | Number of Participants in Glycaemic Category at Week 16 | Pre-diabetes | 4 Participants |
| Part A: Placebo | Number of Participants in Glycaemic Category at Week 16 | Normoglycaemia | 8 Participants |
| Part A: Placebo | Number of Participants in Glycaemic Category at Week 16 | Type 2 diabetes | 0 Participants |
| Part B: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Pre-diabetes | 2 Participants |
| Part B: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Normoglycaemia | 11 Participants |
| Part B: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Type 2 diabetes | 0 Participants |
| Part B: Placebo | Number of Participants in Glycaemic Category at Week 16 | Pre-diabetes | 2 Participants |
| Part B: Placebo | Number of Participants in Glycaemic Category at Week 16 | Normoglycaemia | 5 Participants |
| Part B: Placebo | Number of Participants in Glycaemic Category at Week 16 | Type 2 diabetes | 0 Participants |
| Part A+B: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Pre-diabetes | 4 Participants |
| Part A+B: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Normoglycaemia | 27 Participants |
| Part A+B: Liraglutide | Number of Participants in Glycaemic Category at Week 16 | Type 2 diabetes | 0 Participants |
| Part A+B: Placebo | Number of Participants in Glycaemic Category at Week 16 | Normoglycaemia | 13 Participants |
| Part A+B: Placebo | Number of Participants in Glycaemic Category at Week 16 | Type 2 diabetes | 0 Participants |
| Part A+B: Placebo | Number of Participants in Glycaemic Category at Week 16 | Pre-diabetes | 6 Participants |
Secondary
Number of Participants in Glycaemic Category at Week 52
Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG \<5.6 mmol/L (\<100 mg/dL) and/or HbA1c \<5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes: FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.
Time frame: Week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Pre-diabetes | 2 Participants |
| Part A: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Type 2 diabetes | 1 Participants |
| Part A: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Normoglycaemia | 13 Participants |
| Part A: Placebo | Number of Participants in Glycaemic Category at Week 52 | Type 2 diabetes | 1 Participants |
| Part A: Placebo | Number of Participants in Glycaemic Category at Week 52 | Pre-diabetes | 4 Participants |
| Part A: Placebo | Number of Participants in Glycaemic Category at Week 52 | Normoglycaemia | 4 Participants |
| Part B: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Normoglycaemia | 10 Participants |
| Part B: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Pre-diabetes | 2 Participants |
| Part B: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Type 2 diabetes | 0 Participants |
| Part B: Placebo | Number of Participants in Glycaemic Category at Week 52 | Pre-diabetes | 3 Participants |
| Part B: Placebo | Number of Participants in Glycaemic Category at Week 52 | Normoglycaemia | 2 Participants |
| Part B: Placebo | Number of Participants in Glycaemic Category at Week 52 | Type 2 diabetes | 0 Participants |
| Part A+B: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Pre-diabetes | 4 Participants |
| Part A+B: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Normoglycaemia | 23 Participants |
| Part A+B: Liraglutide | Number of Participants in Glycaemic Category at Week 52 | Type 2 diabetes | 1 Participants |
| Part A+B: Placebo | Number of Participants in Glycaemic Category at Week 52 | Normoglycaemia | 6 Participants |
| Part A+B: Placebo | Number of Participants in Glycaemic Category at Week 52 | Type 2 diabetes | 1 Participants |
| Part A+B: Placebo | Number of Participants in Glycaemic Category at Week 52 | Pre-diabetes | 7 Participants |
Secondary
Number of Participants With Change in ECG From Baseline at Week 52
A 12-lead ECG was performed at baseline (week 0) and week 52 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and week 52 are presented.
Time frame: Week 0, Week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Normal | 20 Participants |
| Part A: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Normal | 17 Participants |
| Part A: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Normal | 9 Participants |
| Part A: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Normal | 13 Participants |
| Part B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Normal | 4 Participants |
| Part B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Normal | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Normal | 37 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Normal | 30 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Normal | 13 Participants |
| Part A+B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 52: Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in ECG From Baseline at Week 52 | Week 0: Normal | 18 Participants |
Secondary
Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16
A 12-lead ECG was performed at baseline (week 0) and week 16 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Number of participants in each ECG category at week 0 and weeks 16 are presented.
Time frame: Week 0, Week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Normal | 20 Participants |
| Part A: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Normal | 17 Participants |
| Part A: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Normal | 13 Participants |
| Part B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Normal | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Normal | 37 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Normal | 30 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 16: Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Electrocardiogram (ECG) From Baseline at Week 16 | Week 0: Normal | 18 Participants |
Secondary
Number of Participants With Change in Physical Examination From Baseline at Week 16
This outcome measure presents number of participants with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 16. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, CS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, NCS | 5 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Normal | 20 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Normal | 16 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, CS | 4 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Normal | 16 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, NCS | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Normal | 15 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Normal | 18 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Normal | 14 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Normal | 17 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Normal | 20 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Normal | 11 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Normal | 15 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, CS | 4 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, NCS | 6 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, CS | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Normal | 18 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Normal | 12 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Normal | 14 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Normal | 11 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, NCS | 3 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Normal | 8 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Normal | 11 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, NCS | 4 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, CS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, NCS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, CS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Normal | 7 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Normal | 9 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Normal | 9 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, NCS | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, CS | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Normal | 11 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, NCS | 4 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Normal | 16 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Normal | 10 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, NCS | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, CS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Normal | 10 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, NCS | 5 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Normal | 14 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, NCS | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Normal | 11 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, NCS | 4 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, CS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Normal | 14 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, CS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, CS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, CS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Normal | 34 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 34 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Normal | 34 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Normal | 22 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, CS | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Normal | 31 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Normal | 32 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, CS | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, CS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, CS | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Normal | 33 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Normal | 34 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Normal | 26 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Normal | 25 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, CS | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, NCS | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, CS | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Normal | 29 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, NCS | 12 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Normal | 37 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Normal | 27 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, NCS | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, CS | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Normal | 29 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, NCS | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, CS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, NCS | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, NCS | 10 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Normal | 33 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Normal | 21 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, NCS | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, NCS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 16 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | GI system including mouth: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Normal | 18 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Abnormal, NCS | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 0 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 0 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | General Appearance: Week 16 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Abnormal, NCS | 5 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Cardiovascular system: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 16 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Respiratory system: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 16 | Normal | 14 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Musculoskeletal system: Week 16 | Abnormal, NCS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Skin: Week 0 | Normal | 13 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 16 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
Secondary
Number of Participants With Change in Physical Examination From Baseline at Week 52
This outcome measure presents number of participants with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0) and week 52. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, CS | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Normal | 17 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Normal | 15 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Normal | 11 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Normal | 17 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Normal | 16 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, CS | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Normal | 15 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Normal | 15 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, CS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, CS | 4 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Normal | 17 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Normal | 20 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Normal | 20 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, NCS | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Normal | 16 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, NCS | 6 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, CS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, CS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Normal | 14 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, NCS | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, NCS | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Normal | 19 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Normal | 13 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Normal | 13 Participants |
| Part A: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Normal | 13 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, NCS | 4 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Normal | 7 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, CS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, NCS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Normal | 11 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Normal | 11 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Normal | 11 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Normal | 11 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Normal | 10 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Normal | 9 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, NCS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, CS | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, NCS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, NCS | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Normal | 12 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, CS | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Normal | 8 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, CS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Normal | 14 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, NCS | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, CS | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, NCS | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Normal | 9 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, NCS | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, CS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 15 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Normal | 16 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, NCS | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Normal | 9 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, CS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, NCS | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Normal | 10 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Normal | 10 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Normal | 17 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, CS | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Normal | 11 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Normal | 12 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, NCS | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Normal | 4 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, CS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Normal | 4 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Normal | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Normal | 6 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, NCS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Normal | 4 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, CS | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Normal | 7 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, NCS | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Normal | 27 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Normal | 24 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, CS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 34 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Normal | 22 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Normal | 29 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Normal | 21 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, CS | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, CS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Normal | 22 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, NCS | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Normal | 29 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, CS | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, NCS | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, NCS | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Normal | 29 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Normal | 36 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, NCS | 12 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Normal | 25 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, CS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, NCS | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, CS | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Normal | 26 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Normal | 31 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, CS | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Normal | 29 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Normal | 37 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, NCS | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Normal | 28 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, CS | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Normal | 14 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 52 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Normal | 13 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 52 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, NCS | 5 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 0 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Cardiovascular system: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Normal | 12 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, NCS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Respiratory system: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Skin: Week 52 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 52 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Normal | 16 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 52 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, CS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 52 | Abnormal, NCS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Thyroid gland: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Abnormal, NCS | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Lymph node palpation: Week 0 | Normal | 19 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | General Appearance: Week 0 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, CS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Abnormal, NCS | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | Musculoskeletal system: Week 0 | Normal | 15 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, CS | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Physical Examination From Baseline at Week 52 | GI system including mouth: Week 52 | Abnormal, NCS | 0 Participants |
Secondary
Number of Participants With Change in Pubertal Status From Baseline at Week 16
This outcome measure presents pubertal status results which is based on Tanner staging recorded at baseline (week 0), week 16. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 2 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 3 | 7 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 4 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 2 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 3 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 2 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 3 | 4 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 2 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 2 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 5 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 2 | 4 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 5 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 2 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 3 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 4 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 5 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 2 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 3 | 8 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 2 | 3 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 1 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 3 | 3 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 3 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 4 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 4 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 3 | 3 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 2 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 1 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 3 | 4 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 5 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 4 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 5 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 4 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 4 | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 2 | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 1 | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 2 | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 2 | 5 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 1 | 5 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 2 | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 1 | 11 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 1 | 2 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 1 | 3 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 1 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 2 | 3 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 1 | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 1 | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 1 | 2 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 1 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 2 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 4 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 5 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 2 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 1 | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 1 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 4 | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 2 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 5 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 3 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 1 | 11 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 4 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 2 | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 1 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 1 | 7 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 3 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 2 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 4 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 2 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 3 | 7 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 2 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 3 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 4 | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 5 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 2 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 1 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 3 | 8 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 1 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 2 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 3 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 5 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 5 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 1 | 6 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 1 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 3 | 5 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 3 | 4 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for male) | Stage 1 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 1 | 6 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 4 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 2 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 1 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 2 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Pubic hair development (for female) | Stage 3 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 1 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Breast development (for female) | Stage 3 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 4 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Penis development (for male) | Stage 3 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 0: Breast development (for female) | Stage 4 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 16 | Week 16: Pubic hair development (for male) | Stage 5 | 2 Participants |
Secondary
Number of Participants With Change in Pubertal Status From Baseline at Week 52
This outcome measure presents pubertal status results which is based on Tanner staging recorded at baseline (week 0) and week 52. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Results are presented for the following categories: 1) For female: breast development and pubic hair development, 2) For male: penis development and pubic hair development. Each category shows number of participants in stages 1 to 5, where stage 1 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 2 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 3 | 8 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 2 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 3 | 5 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 4 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 5 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 2 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 3 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 2 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 2 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 5 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 3 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 5 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 2 | 4 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 5 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 1 | 0 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 2 | 1 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 3 | 2 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 4 | 3 Participants |
| Part A: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 5 | 3 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 3 | 4 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 5 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 5 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 4 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 1 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 3 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 4 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 2 | 3 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 1 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 1 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 2 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 5 | 1 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 4 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 4 | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 4 | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 3 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 1 | 4 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 3 | 4 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 2 | 4 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 2 | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 1 | 6 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 1 | 3 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 2 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 3 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 2 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 1 | 11 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 1 | 2 Participants |
| Part B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 1 | 2 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 1 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 2 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 1 | 3 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 3 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 4 | 1 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 1 | 5 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 1 | 2 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 3 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 5 | 0 Participants |
| Part B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 1 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 1 | 7 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 2 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 3 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 5 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 4 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 4 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 3 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 5 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 2 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 1 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 1 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 4 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 2 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 4 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 5 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 1 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 4 | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 2 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 1 | 11 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 1 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 3 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 2 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 4 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 2 | 5 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 3 | 8 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 3 | 7 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 3 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 4 | 0 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 5 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 2 | 3 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 1 | 4 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 3 | 2 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 1 | 6 Participants |
| Part A+B: Liraglutide | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 5 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 4 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 3 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 5 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 3 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 3 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 4 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 1 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 1 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 4 | 4 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 3 | 5 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 1 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for male) | Stage 5 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 2 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Pubic hair development (for female) | Stage 1 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 2 | 0 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 1 | 6 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 2 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 1 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 5 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 1 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 2 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Breast development (for female) | Stage 3 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for female) | Stage 5 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 1 | 3 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Breast development (for female) | Stage 3 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Penis development (for male) | Stage 3 | 1 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 52: Penis development (for male) | Stage 4 | 2 Participants |
| Part A+B: Placebo | Number of Participants With Change in Pubertal Status From Baseline at Week 52 | Week 0: Pubic hair development (for male) | Stage 5 | 1 Participants |
Secondary
Number of Participants With Occurrence of Anti-liraglutide Antibodies
Number of participants with occurrence of anti-liraglutide antibodies is presented. In the below table, 'Yes' infers number of participants with occurrence of anti- liraglutide antibodies and 'No' infers number of participants without anti- liraglutide antibodies.
Time frame: From week 0 to week 54
Population: SAS which included all participants exposed to at least one dose of trial product. Overall number of participants analysed = Number of participants with available data. Combined data of Part A and B for liraglutide was planned to be reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Number of Participants With Occurrence of Anti-liraglutide Antibodies | Yes | 2 Participants |
| Part A: Liraglutide | Number of Participants With Occurrence of Anti-liraglutide Antibodies | No | 14 Participants |
| Part A: Placebo | Number of Participants With Occurrence of Anti-liraglutide Antibodies | Yes | 1 Participants |
| Part A: Placebo | Number of Participants With Occurrence of Anti-liraglutide Antibodies | No | 8 Participants |
| Part B: Liraglutide | Number of Participants With Occurrence of Anti-liraglutide Antibodies | Yes | 3 Participants |
| Part B: Liraglutide | Number of Participants With Occurrence of Anti-liraglutide Antibodies | No | 22 Participants |
Secondary
Number of Severe Treatment Emergent Episodes of Hypoglycaemia
Hypoglycaemic episode (blood glucose less than or equal to (\<=) 3.9 mmol/L (70 mg/dL) Or greater than (\>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia defined by American Diabetes Association (ADA) 2013 and International Society for Paediatric and Adolescent Diabetes (ISPAD) 2018: hypoglycaemic episode associated with severe cognitive impairment requiring external assistance for recovery. Endpoint was evaluated based on data from in-trial period which was defined as events with onset date on or after the first day of trial product administration and no later than the last study visit (week 54).
Time frame: From week 0 to week 54
Population: SAS which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Liraglutide | Number of Severe Treatment Emergent Episodes of Hypoglycaemia | 0 Episodes |
| Part A: Placebo | Number of Severe Treatment Emergent Episodes of Hypoglycaemia | 0 Episodes |
| Part B: Liraglutide | Number of Severe Treatment Emergent Episodes of Hypoglycaemia | 1 Episodes |
| Part B: Placebo | Number of Severe Treatment Emergent Episodes of Hypoglycaemia | 0 Episodes |
| Part A+B: Liraglutide | Number of Severe Treatment Emergent Episodes of Hypoglycaemia | 1 Episodes |
| Part A+B: Placebo | Number of Severe Treatment Emergent Episodes of Hypoglycaemia | 0 Episodes |
Secondary
Number of Treatment Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period included AEs are with an onset date on or after the first day of trial product administration and any of the following dates, whichever came first: a) 14 days after the last day on trial product, or b) Follow-up visit (week 54) for participants with trial product discontinuation, or c) Last study visit (participants withdrawn without follow-up visit (week 54)).
Time frame: From week 0 to week 54
Population: Safety analysis set (SAS) which included all participants exposed to at least one dose of trial product. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Liraglutide | Number of Treatment Emergent Adverse Events | 134 Events |
| Part A: Placebo | Number of Treatment Emergent Adverse Events | 37 Events |
| Part B: Liraglutide | Number of Treatment Emergent Adverse Events | 159 Events |
| Part B: Placebo | Number of Treatment Emergent Adverse Events | 8 Events |
| Part A+B: Liraglutide | Number of Treatment Emergent Adverse Events | 293 Events |
| Part A+B: Placebo | Number of Treatment Emergent Adverse Events | 45 Events |
Secondary
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16
Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 16. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. This outcome measure was planned to be analyzed for Part A only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16 | -2 Score on a scale | Standard Deviation 4 |
| Part A: Placebo | Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 16 | 1 Score on a scale | Standard Deviation 5 |
Secondary
Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52
Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. This outcome measure was planned to be analyzed for Part A only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Liraglutide | Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52 | -2 Score on a scale | Standard Deviation 3 |
| Part A: Placebo | Part A: Change in Patient Reported Health Questionnaire-9 (PHQ-9) From Baseline at Week 52 | 0 Score on a scale | Standard Deviation 3 |
Secondary
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16
C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is yes for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is yes for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with suicidal ideation or suicidal behaviour on C-SSRS assessed at baseline (week 0), week 16. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time frame: Week 0, week 16
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. This outcome measure was planned to be analyzed for Part A only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 0: Suicidal ideation | 1 Participants |
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 0: Suicidal behaviour | 0 Participants |
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 16: Suicidal ideation | 1 Participants |
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 16: Suicidal behaviour | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 16: Suicidal behaviour | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 0: Suicidal behaviour | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 16: Suicidal ideation | 1 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 16 | Week 0: Suicidal ideation | 3 Participants |
Secondary
Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52
C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidality, suicidal behaviour, suicidal ideation. Suicidality: emergence of any suicidal ideation or suicidal behaviour. Suicidal behaviour: when response is yes for any of the questions- actual attempt to suicide, engaged in non-suicidal self-injurious behaviour, interrupted attempt, aborted attempt, preparatory acts. Suicidal ideation: when response is yes for any of the questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. This outcome measure presents number of participants with suicidal ideation or suicidal behaviour on C-SSRS assessed at baseline (week 0), week 52. The questionnaire was not used in Part B due to the young age of the participants in Part B.
Time frame: Week 0, week 52
Population: SAS which included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Number Analyzed = number of participants with available data. This outcome measure was planned to be analyzed for Part A only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 0: Suicidal ideation | 1 Participants |
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 52: Suicidal ideation | 1 Participants |
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 52: Suicidal behaviour | 0 Participants |
| Part A: Liraglutide | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 0: Suicidal behaviour | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 0: Suicidal behaviour | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 0: Suicidal ideation | 3 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 52: Suicidal behaviour | 0 Participants |
| Part A: Placebo | Part A: Number of Participants With Change in Columbia Suicidality Severity Rating Scale (C-SSRS) at Week 52 | Week 52: Suicidal ideation | 0 Participants |
Secondary
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16
Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16.
Time frame: At week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | Yes | 0 Percentage of participants |
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | No | 100 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | Yes | 0 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | No | 100 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | Yes | 6.3 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | No | 93.8 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | Yes | 14.3 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | No | 85.7 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | Yes | 2.9 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | No | 97.1 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | Yes | 5.3 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16 | No | 94.7 Percentage of participants |
Secondary
Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52
Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52.
Time frame: At week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | No | 88.2 Percentage of participants |
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | Yes | 11.8 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | Yes | 0 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | No | 100 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | Yes | 14.3 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | No | 85.7 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | Yes | 28.6 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | No | 71.4 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | Yes | 12.9 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | No | 87.1 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | No | 88.9 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52 | Yes | 11.1 Percentage of participants |
Secondary
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16
Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16.
Time frame: At week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | Yes | 27.8 Percentage of participants |
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | No | 72.2 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | Yes | 8.3 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | No | 91.7 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | Yes | 37.5 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | No | 62.5 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | Yes | 57.1 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | No | 42.9 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | Yes | 32.4 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | No | 67.6 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | Yes | 26.3 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16 | No | 73.7 Percentage of participants |
Secondary
Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52
Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52.
Time frame: At week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | Yes | 29.4 Percentage of participants |
| Part A: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | No | 70.6 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | Yes | 18.2 Percentage of participants |
| Part A: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | No | 81.8 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | Yes | 35.7 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | No | 64.3 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | Yes | 42.9 Percentage of participants |
| Part B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | No | 57.1 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | Yes | 32.3 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | No | 67.7 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | Yes | 27.8 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52 | No | 72.2 Percentage of participants |
Secondary
Percentage of Participants With no Increase in BMI SDS at Week 16
Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16.
Time frame: At week 16
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 16 | Yes | 66.7 Percentage of participants |
| Part A: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 16 | No | 33.3 Percentage of participants |
| Part A: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 16 | Yes | 75.0 Percentage of participants |
| Part A: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 16 | No | 25.0 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 16 | Yes | 87.5 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 16 | No | 12.5 Percentage of participants |
| Part B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 16 | Yes | 100 Percentage of participants |
| Part B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 16 | No | 0 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 16 | Yes | 76.5 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 16 | No | 23.5 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 16 | Yes | 84.2 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 16 | No | 15.8 Percentage of participants |
Secondary
Percentage of Participants With no Increase in BMI SDS at Week 52
Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52.
Time frame: At week 52
Population: FAS which included all randomised participants who received at least one dose of trial product and had any post-randomisation data. Overall Number of Participants Analyzed = number of participants who contributed to the analysis. Combined data of Part A and B for liraglutide and placebo was planned to be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 52 | No | 29.4 Percentage of participants |
| Part A: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 52 | Yes | 70.6 Percentage of participants |
| Part A: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 52 | No | 27.3 Percentage of participants |
| Part A: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 52 | Yes | 72.7 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 52 | No | 21.4 Percentage of participants |
| Part B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 52 | Yes | 78.6 Percentage of participants |
| Part B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 52 | No | 0 Percentage of participants |
| Part B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 52 | Yes | 100 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 52 | Yes | 73.3 Percentage of participants |
| Part A+B: Liraglutide | Percentage of Participants With no Increase in BMI SDS at Week 52 | No | 26.7 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 52 | No | 18.8 Percentage of participants |
| Part A+B: Placebo | Percentage of Participants With no Increase in BMI SDS at Week 52 | Yes | 81.3 Percentage of participants |