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 pubertal adolescent subjects with obesity.
Interventions
DRUGLiraglutide
Administered once daily subcutaneously (s.c., under the skin)
DRUGPlacebo
Administered once daily subcutaneously (s.c., under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 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 * Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation * BMI corresponding to equal to or above 30 kg/m\^2 for adults by international cut-off points 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 V2 (below 5 kg self-reported weight change) * History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record
Exclusion criteria
* Pre-pubertal subjects (Tanner stage 1) at screening V2 * Type 1 diabetes mellitus (T1DM) * Family or personal history of multiple endocrine neoplasia type 2 (MEN2) * Medullary thyroid carcinoma (MTC) * History of pancreatitis (acute or chronic) * Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes) * Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity) * Anti-diabetic treatment other than metformin * History of major depressive disorder within 2 years before screening V2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI SDS (Week 0, Week 56) | Week 0, week 56 | Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Weeks 30, 56 and 82 | Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. |
| Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | (Week 0, week 30); (Week 0, week 82); (Week 56, week 82) | Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively. |
| Change in BMI | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. |
| Change in Body Weight (kg) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. |
| Change in Body Weight (%) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. |
| Change in Body Weight (lb) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only. |
| Change in Waist Circumference | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Waist-to-hip Circumference Ratio | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in hsCRP | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting Lipid: FFA (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Systolic and Diastolic Blood Pressure | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in HbA1c | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in FPG | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82). |
| Change in Fasting Insulin (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Fasting C-peptide (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Glycaemic Category | Week -2, week 30, week 56 and week 82 | Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes (T2DM) at baseline (weeks -2), and weeks 30, 56 and 82 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 (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: TSH and Prolactin | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in hormone levels, thyroid stimulating hormone (TSH) and prolactin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in HOMA-B (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin\[mU/L\]/(FPG\[mmol/L\]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in HOMA-IR (Ratio to Baseline) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin \[mU/L\] x FPG \[mmol/L\]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in IWQOL-Kids | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in BMI SDS (%) | (Week 0, week 30); (Week 0, week 56) | Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56. |
| Change in Nutritional Compliance | Week 0, week 30 and week 56 | This outcome measure presents nutritional compliance results recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56. |
| Number of Treatment Emergent Adverse Events | Week 0-56 + 14 days | A treatment emergent adverse event (TEAE) was defined as an event that occurred in the on-treatment period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit). |
| Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Week 0-56 + 14 days | A hypoglycaemic episode was 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 episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia. |
| Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Week 0-56 + 14 days | Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. |
| Occurrence of Anti-liraglutide Antibodies | Weeks 0, 30, 56, 58, 70 and 82 | This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented. |
| Change in Pulse | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in ECG | Week -14, week 30, week 56 and week 82 | This outcome measure presents number of subjects with electrocardiogram findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56. |
| Change in Haematology: Haemoglobin | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Haematology: Haematocrit | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in haematological parameters, thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Haematology: Erythrocytes | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Biochemistry: Creatinine and Bilirubin (Total) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in biochemistry parameters, creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in biochemistry parameters, urea (blood urea nitrogen \[BUN\]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected was evaluated from baseline (week \[Wk\] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Biochemistry: Albumin | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Biochemistry: CEA | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: Calcitonin | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: Free T4 and ACTH | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in hormone levels, thyroxine (T4) and adrenocorticotropic hormone (ACTH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: IGF-1 and Cortisol | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in hormone levels, insulin-like growth factor-1 (IGF-1) and cortisol was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: DHEAS | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: LH and FSH | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in hormone levels, luteinising hormone (LH) and follicle stimulating hormone (FSH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: Estradiol (Females) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Hormone Level: Testosterone (Males) | Week 0, week 30, week 56 and week 82 | This outcome measure presents testosterone (only for males) results for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in NTX1 | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in nmol bone collagen equivalents (BCE)/L. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in CTX1 | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Weeks 30, 56 and 82 | Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. |
| Change in Alkaline Phosphatase (Bone) | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Pubertal Status | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | This outcome measure presents pubertal status results which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Physical Examination | Week 0, week 30, week 56 and week 82 | This outcome measure presents number of subjects with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 30, week 56 and week 82. 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. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in Height SDS | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively. |
| Change in C-SSRS | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | This outcome measure presents number of subjects with suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS) assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in PHQ-9 | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. 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. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
| Change in P1NP | (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) | Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82. |
Countries
Belgium, Mexico, Russia, Sweden, United States
Participant flow
Recruitment details
This trial was conducted at 32 sites in 5 countries: Belgium (6 sites), Sweden (4 sites), Russia (8 sites), Mexico (2 sites) and the United States of America (USA - 12 sites). Additionally, 1 site in the USA was approved by the independent review board, but did not randomise any participant.
Pre-assignment details
This trial consisted of a 12-week run-in period, during which participants received counselling on healthy nutrition and physical activity. Completed numbers include participants who completed the trial without prematurely discontinuing the trial product and participants who discontinued the trial product but came for the week 82 follow-up visit.
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide 3.0 mg Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals. | 125 |
| Placebo Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals. | 126 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 |
| Overall Study | Other | 3 | 1 |
| Overall Study | Withdrawal by parent/guardian | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 15 |
Baseline characteristics
| Characteristic | Placebo | Total | Liraglutide 3.0 mg |
|---|---|---|---|
| Age, Continuous | 14.5 Years STANDARD_DEVIATION 1.6 | 14.5 Years STANDARD_DEVIATION 1.6 | 14.6 Years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 56 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 195 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 20 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 115 Participants | 220 Participants | 105 Participants |
| Sex: Female, Male Female | 78 Participants | 149 Participants | 71 Participants |
| Sex: Female, Male Male | 48 Participants | 102 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 125 | 0 / 126 |
| other Total, other adverse events | 100 / 125 | 84 / 126 |
| serious Total, serious adverse events | 3 / 125 | 5 / 126 |
Outcome results
Primary
Change in BMI SDS (Week 0, Week 56)
Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.
Time frame: Week 0, week 56
Population: Results are based on the full analysis set (FAS) which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat \[ITT\] principle). Overall Number of Participants Analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in BMI SDS (Week 0, Week 56) | -0.25 SDS score | Standard Deviation 0.51 |
| Placebo | Change in BMI SDS (Week 0, Week 56) | -0.02 SDS score | Standard Deviation 0.54 |
Comparison: Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.p-value: 0.002295% CI: [-0.37, -0.08]ANCOVA
Secondary
Change in Alkaline Phosphatase (Bone)
Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Alkaline Phosphatase (Bone) | Change from week 0 to week 30 | -15 U/L | Standard Deviation 16 |
| Liraglutide 3.0 mg | Change in Alkaline Phosphatase (Bone) | Change from week 0 to week 56 | -17 U/L | Standard Deviation 18 |
| Liraglutide 3.0 mg | Change in Alkaline Phosphatase (Bone) | Change from week 56 to week 82 | -1 U/L | Standard Deviation 11 |
| Placebo | Change in Alkaline Phosphatase (Bone) | Change from week 0 to week 30 | -12 U/L | Standard Deviation 26 |
| Placebo | Change in Alkaline Phosphatase (Bone) | Change from week 0 to week 56 | -17 U/L | Standard Deviation 30 |
| Placebo | Change in Alkaline Phosphatase (Bone) | Change from week 56 to week 82 | -4 U/L | Standard Deviation 12 |
Secondary
Change in Biochemistry: Albumin
Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Biochemistry: Albumin | Change from week 0 to week 30 | 0.1 g/dL | Standard Deviation 0.2 |
| Liraglutide 3.0 mg | Change in Biochemistry: Albumin | Change from week 0 to week 56 | 0.1 g/dL | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change in Biochemistry: Albumin | Change from week 56 to week 82 | -0.0 g/dL | Standard Deviation 0.2 |
| Placebo | Change in Biochemistry: Albumin | Change from week 0 to week 30 | 0.0 g/dL | Standard Deviation 0.3 |
| Placebo | Change in Biochemistry: Albumin | Change from week 0 to week 56 | 0.1 g/dL | Standard Deviation 0.3 |
| Placebo | Change in Biochemistry: Albumin | Change from week 56 to week 82 | -0.0 g/dL | Standard Deviation 0.3 |
Secondary
Change in Biochemistry: CEA
Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Biochemistry: CEA | Change from week 0 to week 30 | -0.0 ng/mL | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change in Biochemistry: CEA | Change from week 0 to week 56 | 0.0 ng/mL | Standard Deviation 0.4 |
| Liraglutide 3.0 mg | Change in Biochemistry: CEA | Change from week 56 to week 82 | 0.0 ng/mL | Standard Deviation 0.4 |
| Placebo | Change in Biochemistry: CEA | Change from week 0 to week 30 | -0.1 ng/mL | Standard Deviation 0.6 |
| Placebo | Change in Biochemistry: CEA | Change from week 0 to week 56 | -0.0 ng/mL | Standard Deviation 0.6 |
| Placebo | Change in Biochemistry: CEA | Change from week 56 to week 82 | 0.0 ng/mL | Standard Deviation 0.3 |
Secondary
Change in Biochemistry: Creatinine and Bilirubin (Total)
Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine and Bilirubin (Total) | Creatinine: Change from week 0 to week 56 | 2 umol/L | Standard Deviation 7 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine and Bilirubin (Total) | Bilirubin (total): Change from week 0 to week 30 | 1 umol/L | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine and Bilirubin (Total) | Creatinine: Change from week 0 to week 30 | 1 umol/L | Standard Deviation 7 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine and Bilirubin (Total) | Bilirubin (total): Change from week 0 to week 56 | 1 umol/L | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine and Bilirubin (Total) | Creatinine: Change from week 56 to week 82 | 2 umol/L | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine and Bilirubin (Total) | Bilirubin (total): Change from week 56 to week 82 | 0 umol/L | Standard Deviation 5 |
| Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) | Creatinine: Change from week 56 to week 82 | 1 umol/L | Standard Deviation 10 |
| Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) | Creatinine: Change from week 0 to week 30 | 0 umol/L | Standard Deviation 8 |
| Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) | Creatinine: Change from week 0 to week 56 | 4 umol/L | Standard Deviation 9 |
| Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) | Bilirubin (total): Change from week 56 to week 82 | -0 umol/L | Standard Deviation 4 |
| Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) | Bilirubin (total): Change from week 0 to week 30 | 1 umol/L | Standard Deviation 5 |
| Placebo | Change in Biochemistry: Creatinine and Bilirubin (Total) | Bilirubin (total): Change from week 0 to week 56 | 1 umol/L | Standard Deviation 5 |
Secondary
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Change in biochemistry parameters, creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Creatinine kinase: Change from week 0 to week 30 | 13 U/L | Standard Deviation 251 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Creatinine kinase: Change from week 0 to week 56 | 32 U/L | Standard Deviation 228 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Creatinine kinase: Change from week 56 to week 82 | 28 U/L | Standard Deviation 321 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Amylase: Change from week 0 to week 30 | 4 U/L | Standard Deviation 12 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Amylase: Change from week 0 to week 56 | 2 U/L | Standard Deviation 10 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Amylase: Change from week 56 to week 82 | -1 U/L | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Lipase: Change from week 0 to week 30 | 6 U/L | Standard Deviation 13 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Lipase: Change from week 0 to week 56 | 3 U/L | Standard Deviation 13 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Lipase: Change from week 56 to week 82 | -4 U/L | Standard Deviation 9 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALT: Change from week 0 to week 30 | -2 U/L | Standard Deviation 15 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALT: Change from week 0 to week 56 | -2 U/L | Standard Deviation 16 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALT: Change from week 56 to week 82 | 1 U/L | Standard Deviation 12 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | AST: Change from week 0 to week 30 | -1 U/L | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | AST: Change from week 0 to week 56 | -1 U/L | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | AST: Change from week 56 to week 82 | 1 U/L | Standard Deviation 12 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALP: Change from week 0 to week 30 | -16 U/L | Standard Deviation 25 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALP: Change from week 0 to week 56 | -23 U/L | Standard Deviation 36 |
| Liraglutide 3.0 mg | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALP: Change from week 56 to week 82 | -2 U/L | Standard Deviation 22 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | AST: Change from week 0 to week 56 | -1 U/L | Standard Deviation 11 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Creatinine kinase: Change from week 0 to week 30 | 0 U/L | Standard Deviation 225 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALT: Change from week 0 to week 30 | -1 U/L | Standard Deviation 15 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Creatinine kinase: Change from week 0 to week 56 | 0 U/L | Standard Deviation 111 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALP: Change from week 56 to week 82 | -10 U/L | Standard Deviation 24 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Creatinine kinase: Change from week 56 to week 82 | 4 U/L | Standard Deviation 114 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALT: Change from week 0 to week 56 | -0 U/L | Standard Deviation 23 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Amylase: Change from week 0 to week 30 | 3 U/L | Standard Deviation 16 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | AST: Change from week 56 to week 82 | 1 U/L | Standard Deviation 11 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Amylase: Change from week 0 to week 56 | -0 U/L | Standard Deviation 9 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALT: Change from week 56 to week 82 | 2 U/L | Standard Deviation 20 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Amylase: Change from week 56 to week 82 | 1 U/L | Standard Deviation 11 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALP: Change from week 0 to week 56 | -19 U/L | Standard Deviation 53 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Lipase: Change from week 0 to week 30 | 1 U/L | Standard Deviation 19 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | AST: Change from week 0 to week 30 | -1 U/L | Standard Deviation 11 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Lipase: Change from week 0 to week 56 | -2 U/L | Standard Deviation 5 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | ALP: Change from week 0 to week 30 | -8 U/L | Standard Deviation 66 |
| Placebo | Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP | Lipase: Change from week 56 to week 82 | -0 U/L | Standard Deviation 5 |
Secondary
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected
Change in biochemistry parameters, urea (blood urea nitrogen \[BUN\]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected was evaluated from baseline (week \[Wk\] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Calcium total: Change from week 0 to week 56 | -0.04 mmol/L | Standard Deviation 0.1 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Urea (BUN): Change from week 0 to week 30 | -0.06 mmol/L | Standard Deviation 1.07 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Urea (BUN): Change from week 0 to week 56 | -0.26 mmol/L | Standard Deviation 1.01 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Urea (BUN): Change from week 56 to week 82 | 0.23 mmol/L | Standard Deviation 1.11 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Sodium: Change from week 0 to week 30 | 0 mmol/L | Standard Deviation 2 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Sodium: Change from week 0 to week 56 | 0 mmol/L | Standard Deviation 2 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Sodium: Change from week 56 to week 82 | -1 mmol/L | Standard Deviation 3 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Potassium: Change from week 0 to week 30 | -0.0 mmol/L | Standard Deviation 0.4 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Potassium: Change from week 0 to week 56 | -0.1 mmol/L | Standard Deviation 0.4 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Potassium: Change from week 56 to week 82 | 0.0 mmol/L | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Calcium total: Change from week 0 to week 30 | -0.01 mmol/L | Standard Deviation 0.09 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Calcium total: Change from week 56 to week 82 | -0.00 mmol/L | Standard Deviation 0.09 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Ca albumin-corrected:Change from week 0 to week 30 | -0.04 mmol/L | Standard Deviation 0.09 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Ca albumin-corrected:Change from week 0 to week 56 | -0.07 mmol/L | Standard Deviation 0.1 |
| Liraglutide 3.0 mg | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Ca albumin-corrected: Change from Wk 56 to Wk 82 | 0.01 mmol/L | Standard Deviation 0.07 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Calcium total: Change from week 56 to week 82 | -0.01 mmol/L | Standard Deviation 0.09 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Potassium: Change from week 0 to week 56 | -0.0 mmol/L | Standard Deviation 0.3 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Urea (BUN): Change from week 0 to week 30 | 0.00 mmol/L | Standard Deviation 1.14 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Ca albumin-corrected:Change from week 0 to week 56 | -0.07 mmol/L | Standard Deviation 0.08 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Urea (BUN): Change from week 0 to week 56 | -0.05 mmol/L | Standard Deviation 1.19 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Potassium: Change from week 56 to week 82 | -0.0 mmol/L | Standard Deviation 0.4 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Urea (BUN): Change from week 56 to week 82 | 0.00 mmol/L | Standard Deviation 1.07 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Ca albumin-corrected:Change from week 0 to week 30 | -0.03 mmol/L | Standard Deviation 0.09 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Sodium: Change from week 0 to week 30 | 0 mmol/L | Standard Deviation 2 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Calcium total: Change from week 0 to week 30 | -0.03 mmol/L | Standard Deviation 0.09 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Sodium: Change from week 0 to week 56 | 0 mmol/L | Standard Deviation 3 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Calcium total: Change from week 0 to week 56 | -0.04 mmol/L | Standard Deviation 0.09 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Sodium: Change from week 56 to week 82 | -1 mmol/L | Standard Deviation 3 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Ca albumin-corrected: Change from Wk 56 to Wk 82 | -0.00 mmol/L | Standard Deviation 0.09 |
| Placebo | Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected | Potassium: Change from week 0 to week 30 | 0.0 mmol/L | Standard Deviation 0.3 |
Secondary
Change in BMI
Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in BMI | Change from week 0 to week 30 | -1.8 kg/m^2 | Standard Deviation 2.1 |
| Liraglutide 3.0 mg | Change in BMI | Change from week 0 to week 56 | -1.6 kg/m^2 | Standard Deviation 3.1 |
| Liraglutide 3.0 mg | Change in BMI | Change from week 56 to week 82 | 1.5 kg/m^2 | Standard Deviation 1.7 |
| Placebo | Change in BMI | Change from week 0 to week 30 | -0.2 kg/m^2 | Standard Deviation 2.2 |
| Placebo | Change in BMI | Change from week 0 to week 56 | 0.1 kg/m^2 | Standard Deviation 3.4 |
| Placebo | Change in BMI | Change from week 56 to week 82 | 0.7 kg/m^2 | Standard Deviation 1.7 |
Secondary
Change in BMI SDS (%)
Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time frame: (Week 0, week 30); (Week 0, week 56)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat \[ITT\] principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in BMI SDS (%) | Change from week 0 to week 30 | -8.73 Percentage change | Standard Error 1.05 |
| Liraglutide 3.0 mg | Change in BMI SDS (%) | Change from week 0 to week 56 | -8.32 Percentage change | Standard Error 1.68 |
| Placebo | Change in BMI SDS (%) | Change from week 0 to week 30 | -1.70 Percentage change | Standard Error 1.07 |
| Placebo | Change in BMI SDS (%) | Change from week 0 to week 56 | -0.68 Percentage change | Standard Error 1.74 |
Secondary
Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.
Time frame: (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat \[ITT\] principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | Change from week 0 to week 30 | -0.26 SDS score | Standard Deviation 0.34 |
| Liraglutide 3.0 mg | Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | Change from week 0 to week 82 | -0.06 SDS score | Standard Deviation 0.53 |
| Liraglutide 3.0 mg | Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | Change from week 56 to week 82 | 0.22 SDS score | Standard Deviation 0.28 |
| Placebo | Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | Change from week 0 to week 30 | -0.04 SDS score | Standard Deviation 0.33 |
| Placebo | Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | Change from week 0 to week 82 | 0.07 SDS score | Standard Deviation 0.66 |
| Placebo | Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82)) | Change from week 56 to week 82 | 0.08 SDS score | Standard Deviation 0.27 |
Secondary
Change in Body Weight (%)
Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Body Weight (%) | Change from week 0 to week 30 | -4.3 Percentage change | Standard Deviation 6.5 |
| Liraglutide 3.0 mg | Change in Body Weight (%) | Change from week 0 to week 56 | -3.2 Percentage change | Standard Deviation 9.4 |
| Liraglutide 3.0 mg | Change in Body Weight (%) | Change from week 56 to week 82 | 5.3 Percentage change | Standard Deviation 5.7 |
| Placebo | Change in Body Weight (%) | Change from week 0 to week 30 | 0.4 Percentage change | Standard Deviation 6.2 |
| Placebo | Change in Body Weight (%) | Change from week 0 to week 56 | 2.2 Percentage change | Standard Deviation 9.5 |
| Placebo | Change in Body Weight (%) | Change from week 56 to week 82 | 2.3 Percentage change | Standard Deviation 4.9 |
Secondary
Change in Body Weight (kg)
Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Body Weight (kg) | Change from week 0 to week 56 | -2.7 kg | Standard Deviation 9.1 |
| Liraglutide 3.0 mg | Change in Body Weight (kg) | Change from week 0 to week 30 | -3.9 kg | Standard Deviation 6.1 |
| Liraglutide 3.0 mg | Change in Body Weight (kg) | Change from week 56 to week 82 | 4.7 kg | Standard Deviation 4.6 |
| Placebo | Change in Body Weight (kg) | Change from week 0 to week 30 | 0.4 kg | Standard Deviation 6.6 |
| Placebo | Change in Body Weight (kg) | Change from week 0 to week 56 | 2.1 kg | Standard Deviation 10.2 |
| Placebo | Change in Body Weight (kg) | Change from week 56 to week 82 | 2.4 kg | Standard Deviation 4.9 |
Secondary
Change in Body Weight (lb)
Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Body weight was not analysed in pounds (lb).
Secondary
Change in C-SSRS
This outcome measure presents number of subjects with suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS) assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 0: Suicidal behaviour | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 56: Suicidal ideation | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 30: Suicidal ideation | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 56: Suicidal behaviour | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 0: Suicidal ideation | 2 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk56: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 30: Suicidal behaviour | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 82: Suicidal ideation | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk0: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk 82: Suicidal behaviour | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk30: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Liraglutide 3.0 mg | Change in C-SSRS | Wk82: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Placebo | Change in C-SSRS | Wk82: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Placebo | Change in C-SSRS | Wk 0: Suicidal ideation | 2 Participants |
| Placebo | Change in C-SSRS | Wk 0: Suicidal behaviour | 1 Participants |
| Placebo | Change in C-SSRS | Wk0: Self-injurious behaviour, no suicidal intent | 1 Participants |
| Placebo | Change in C-SSRS | Wk 30: Suicidal ideation | 0 Participants |
| Placebo | Change in C-SSRS | Wk 30: Suicidal behaviour | 0 Participants |
| Placebo | Change in C-SSRS | Wk30: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Placebo | Change in C-SSRS | Wk 56: Suicidal ideation | 0 Participants |
| Placebo | Change in C-SSRS | Wk 56: Suicidal behaviour | 0 Participants |
| Placebo | Change in C-SSRS | Wk56: Self-injurious behaviour, no suicidal intent | 0 Participants |
| Placebo | Change in C-SSRS | Wk 82: Suicidal ideation | 0 Participants |
| Placebo | Change in C-SSRS | Wk 82: Suicidal behaviour | 0 Participants |
Secondary
Change in CTX1
Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in CTX1 | Change from week 0 to week 30 | -7 pg/mL | Standard Deviation 358 |
| Liraglutide 3.0 mg | Change in CTX1 | Change from week 0 to week 56 | -36 pg/mL | Standard Deviation 353 |
| Liraglutide 3.0 mg | Change in CTX1 | Change from week 56 to week 82 | -107 pg/mL | Standard Deviation 359 |
| Placebo | Change in CTX1 | Change from week 0 to week 30 | -84 pg/mL | Standard Deviation 404 |
| Placebo | Change in CTX1 | Change from week 0 to week 56 | -97 pg/mL | Standard Deviation 473 |
| Placebo | Change in CTX1 | Change from week 56 to week 82 | -162 pg/mL | Standard Deviation 318 |
Secondary
Change in ECG
This outcome measure presents number of subjects with electrocardiogram findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time frame: Week -14, week 30, week 56 and week 82
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in ECG | Week 56 | Normal | 83 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week -14 | Abnormal, NCS | 23 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week -14 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week 30 | Normal | 97 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week -14 | Normal | 102 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week 30 | Abnormal, NCS | 20 Participants |
| Liraglutide 3.0 mg | Change in ECG | Week 56 | Abnormal, NCS | 21 Participants |
| Placebo | Change in ECG | Week 30 | Abnormal, NCS | 21 Participants |
| Placebo | Change in ECG | Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in ECG | Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in ECG | Week 56 | Normal | 80 Participants |
| Placebo | Change in ECG | Week 56 | Abnormal, NCS | 23 Participants |
| Placebo | Change in ECG | Week -14 | Normal | 100 Participants |
| Placebo | Change in ECG | Week -14 | Abnormal, NCS | 26 Participants |
| Placebo | Change in ECG | Week -14 | Abnormal, CS | 0 Participants |
| Placebo | Change in ECG | Week 30 | Normal | 95 Participants |
Secondary
Change in Fasting C-peptide (Ratio to Baseline)
Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting C-peptide (Ratio to Baseline) | Change from week 0 to week 56 | 0.98 Ratio of fasting C-peptide | Geometric Coefficient of Variation 44.9 |
| Liraglutide 3.0 mg | Change in Fasting C-peptide (Ratio to Baseline) | Change from week 0 to week 30 | 1.12 Ratio of fasting C-peptide | Geometric Coefficient of Variation 42.6 |
| Liraglutide 3.0 mg | Change in Fasting C-peptide (Ratio to Baseline) | Change from week 56 to week 82 | 0.92 Ratio of fasting C-peptide | Geometric Coefficient of Variation 43.6 |
| Placebo | Change in Fasting C-peptide (Ratio to Baseline) | Change from week 0 to week 30 | 1.04 Ratio of fasting C-peptide | Geometric Coefficient of Variation 35.1 |
| Placebo | Change in Fasting C-peptide (Ratio to Baseline) | Change from week 0 to week 56 | 0.97 Ratio of fasting C-peptide | Geometric Coefficient of Variation 47.4 |
| Placebo | Change in Fasting C-peptide (Ratio to Baseline) | Change from week 56 to week 82 | 0.94 Ratio of fasting C-peptide | Geometric Coefficient of Variation 32.9 |
Secondary
Change in Fasting Insulin (Ratio to Baseline)
Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Insulin (Ratio to Baseline) | Change from week 0 to week 56 | 1.06 Ratio of fasting insulin | Geometric Coefficient of Variation 69.4 |
| Liraglutide 3.0 mg | Change in Fasting Insulin (Ratio to Baseline) | Change from week 56 to week 82 | 1.00 Ratio of fasting insulin | Geometric Coefficient of Variation 60.9 |
| Liraglutide 3.0 mg | Change in Fasting Insulin (Ratio to Baseline) | Change from week 0 to week 30 | 1.13 Ratio of fasting insulin | Geometric Coefficient of Variation 70.9 |
| Placebo | Change in Fasting Insulin (Ratio to Baseline) | Change from week 0 to week 56 | 1.10 Ratio of fasting insulin | Geometric Coefficient of Variation 73.8 |
| Placebo | Change in Fasting Insulin (Ratio to Baseline) | Change from week 0 to week 30 | 1.14 Ratio of fasting insulin | Geometric Coefficient of Variation 53.7 |
| Placebo | Change in Fasting Insulin (Ratio to Baseline) | Change from week 56 to week 82 | 1.08 Ratio of fasting insulin | Geometric Coefficient of Variation 55.2 |
Secondary
Change in Fasting Lipid: FFA (Ratio to Baseline)
Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: FFA (Ratio to Baseline) | Change from week 0 to week 30 | 0.96 Ratio of FFA | Geometric Coefficient of Variation 57.7 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: FFA (Ratio to Baseline) | Change from week 0 to week 56 | 1.00 Ratio of FFA | Geometric Coefficient of Variation 48.9 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: FFA (Ratio to Baseline) | Change from week 56 to week 82 | 0.99 Ratio of FFA | Geometric Coefficient of Variation 55.2 |
| Placebo | Change in Fasting Lipid: FFA (Ratio to Baseline) | Change from week 0 to week 30 | 0.83 Ratio of FFA | Geometric Coefficient of Variation 56.4 |
| Placebo | Change in Fasting Lipid: FFA (Ratio to Baseline) | Change from week 0 to week 56 | 0.95 Ratio of FFA | Geometric Coefficient of Variation 50.8 |
| Placebo | Change in Fasting Lipid: FFA (Ratio to Baseline) | Change from week 56 to week 82 | 0.94 Ratio of FFA | Geometric Coefficient of Variation 38 |
Secondary
Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)
Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 1.04 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 15.3 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 1.04 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 17.4 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 0.99 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 15.8 |
| Placebo | Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 1.01 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 20.5 |
| Placebo | Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 1.02 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 18.9 |
| Placebo | Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.00 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 15.2 |
Secondary
Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)
Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 1.00 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 19.8 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 0.99 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 21.8 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.03 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 22.5 |
| Placebo | Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 1.00 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 26.1 |
| Placebo | Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 1.02 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 23.6 |
| Placebo | Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.04 Ratio of LDL-cholesterol | Geometric Coefficient of Variation 20.6 |
Secondary
Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)
Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 0.98 Ratio of non-HDL cholesterol | Geometric Coefficient of Variation 16.8 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 0.98 Ratio of non-HDL cholesterol | Geometric Coefficient of Variation 18.4 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.03 Ratio of non-HDL cholesterol | Geometric Coefficient of Variation 19.8 |
| Placebo | Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 0.97 Ratio of non-HDL cholesterol | Geometric Coefficient of Variation 18 |
| Placebo | Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 0.99 Ratio of non-HDL cholesterol | Geometric Coefficient of Variation 16.7 |
| Placebo | Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.02 Ratio of non-HDL cholesterol | Geometric Coefficient of Variation 18.6 |
Secondary
Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)
Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 14.2 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 12.8 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.02 Ratio of total cholesterol | Geometric Coefficient of Variation 14.7 |
| Placebo | Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.02 Ratio of total cholesterol | Geometric Coefficient of Variation 14.9 |
| Placebo | Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 13 |
| Placebo | Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 13 |
Secondary
Change in Fasting Lipid: Triglycerides (Ratio to Baseline)
Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | Change from week 0 to week 30 | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 36.9 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | Change from week 0 to week 56 | 0.92 Ratio of triglycerides | Geometric Coefficient of Variation 43.2 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | Change from week 56 to week 82 | 1.04 Ratio of triglycerides | Geometric Coefficient of Variation 50.4 |
| Placebo | Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | Change from week 0 to week 30 | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 42.9 |
| Placebo | Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | Change from week 0 to week 56 | 0.93 Ratio of triglycerides | Geometric Coefficient of Variation 34.4 |
| Placebo | Change in Fasting Lipid: Triglycerides (Ratio to Baseline) | Change from week 56 to week 82 | 0.97 Ratio of triglycerides | Geometric Coefficient of Variation 34 |
Secondary
Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)
Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 0.91 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.8 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 0.92 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 43.7 |
| Liraglutide 3.0 mg | Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 1.04 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 51 |
| Placebo | Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 30 | 0.90 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 42.7 |
| Placebo | Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | Change from week 0 to week 56 | 0.93 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 34.6 |
| Placebo | Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline) | Change from week 56 to week 82 | 0.97 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 34.1 |
Secondary
Change in FPG
Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in FPG | Change from week 0 to week 30 | -0.2 mmol/L | Standard Deviation 0.4 |
| Liraglutide 3.0 mg | Change in FPG | Change from week 0 to week 56 | -0.1 mmol/L | Standard Deviation 0.5 |
| Liraglutide 3.0 mg | Change in FPG | Change from week 56 to week 82 | 0.1 mmol/L | Standard Deviation 0.6 |
| Placebo | Change in FPG | Change from week 0 to week 30 | -0.0 mmol/L | Standard Deviation 0.5 |
| Placebo | Change in FPG | Change from week 0 to week 56 | -0.0 mmol/L | Standard Deviation 0.6 |
| Placebo | Change in FPG | Change from week 56 to week 82 | 0.1 mmol/L | Standard Deviation 0.5 |
Secondary
Change in Glycaemic Category
Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes (T2DM) at baseline (weeks -2), and weeks 30, 56 and 82 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 (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: Week -2, week 30, week 56 and week 82
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 56 | Normoglycaemia | 86 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 30 | Normoglycaemia | 95 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 56 | Pre-diabetes | 17 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week -2 | Normoglycaemia | 93 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 56 | Type 2 diabetes | 2 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 30 | Pre-diabetes | 19 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 82 | Normoglycaemia | 79 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week -2 | Type 2 diabetes | 1 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 82 | Pre-diabetes | 20 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 30 | Type 2 diabetes | 2 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week 82 | Type 2 diabetes | 1 Participants |
| Liraglutide 3.0 mg | Change in Glycaemic Category | Week -2 | Pre-diabetes | 31 Participants |
| Placebo | Change in Glycaemic Category | Week 82 | Type 2 diabetes | 4 Participants |
| Placebo | Change in Glycaemic Category | Week -2 | Pre-diabetes | 32 Participants |
| Placebo | Change in Glycaemic Category | Week -2 | Type 2 diabetes | 1 Participants |
| Placebo | Change in Glycaemic Category | Week 30 | Normoglycaemia | 86 Participants |
| Placebo | Change in Glycaemic Category | Week 30 | Pre-diabetes | 29 Participants |
| Placebo | Change in Glycaemic Category | Week 30 | Type 2 diabetes | 1 Participants |
| Placebo | Change in Glycaemic Category | Week 56 | Normoglycaemia | 75 Participants |
| Placebo | Change in Glycaemic Category | Week 56 | Pre-diabetes | 24 Participants |
| Placebo | Change in Glycaemic Category | Week 56 | Type 2 diabetes | 2 Participants |
| Placebo | Change in Glycaemic Category | Week 82 | Normoglycaemia | 65 Participants |
| Placebo | Change in Glycaemic Category | Week 82 | Pre-diabetes | 30 Participants |
| Placebo | Change in Glycaemic Category | Week -2 | Normoglycaemia | 93 Participants |
Secondary
Change in Haematology: Erythrocytes
Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Haematology: Erythrocytes | Change from week 0 to week 30 | 0.0 10^12 cells/L | Standard Deviation 0.2 |
| Liraglutide 3.0 mg | Change in Haematology: Erythrocytes | Change from week 0 to week 56 | -0.0 10^12 cells/L | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change in Haematology: Erythrocytes | Change from week 56 to week 82 | -0.1 10^12 cells/L | Standard Deviation 0.3 |
| Placebo | Change in Haematology: Erythrocytes | Change from week 0 to week 30 | -0.0 10^12 cells/L | Standard Deviation 0.3 |
| Placebo | Change in Haematology: Erythrocytes | Change from week 0 to week 56 | -0.1 10^12 cells/L | Standard Deviation 0.3 |
| Placebo | Change in Haematology: Erythrocytes | Change from week 56 to week 82 | 0.0 10^12 cells/L | Standard Deviation 0.2 |
Secondary
Change in Haematology: Haematocrit
Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Haematology: Haematocrit | Change from week 0 to week 30 | 0.7 % of red blood cells | Standard Deviation 2.3 |
| Liraglutide 3.0 mg | Change in Haematology: Haematocrit | Change from week 0 to week 56 | 1.2 % of red blood cells | Standard Deviation 2.7 |
| Liraglutide 3.0 mg | Change in Haematology: Haematocrit | Change from week 56 to week 82 | -0.4 % of red blood cells | Standard Deviation 2.9 |
| Placebo | Change in Haematology: Haematocrit | Change from week 0 to week 30 | 0.1 % of red blood cells | Standard Deviation 2.4 |
| Placebo | Change in Haematology: Haematocrit | Change from week 0 to week 56 | 0.4 % of red blood cells | Standard Deviation 2.8 |
| Placebo | Change in Haematology: Haematocrit | Change from week 56 to week 82 | -0.4 % of red blood cells | Standard Deviation 1.9 |
Secondary
Change in Haematology: Haemoglobin
Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Haematology: Haemoglobin | Change from week 0 to week 30 | 0.2 mmol/L | Standard Deviation 0.5 |
| Liraglutide 3.0 mg | Change in Haematology: Haemoglobin | Change from week 0 to week 56 | 0.3 mmol/L | Standard Deviation 0.6 |
| Liraglutide 3.0 mg | Change in Haematology: Haemoglobin | Change from week 56 to week 82 | -0.1 mmol/L | Standard Deviation 0.6 |
| Placebo | Change in Haematology: Haemoglobin | Change from week 0 to week 30 | 0.0 mmol/L | Standard Deviation 0.4 |
| Placebo | Change in Haematology: Haemoglobin | Change from week 0 to week 56 | 0.1 mmol/L | Standard Deviation 0.6 |
| Placebo | Change in Haematology: Haemoglobin | Change from week 56 to week 82 | -0.0 mmol/L | Standard Deviation 0.4 |
Secondary
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes
Change in haematological parameters, thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Thrombocytes: Change from week 0 to week 30 | 9 10^9 cells/L | Standard Deviation 37 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Thrombocytes: Change from week 0 to week 56 | 7 10^9 cells/L | Standard Deviation 46 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Thrombocytes: Change from week 56 to week 82 | -2 10^9 cells/L | Standard Deviation 31 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Leucocytes: Change from week 0 to week 30 | 0.1 10^9 cells/L | Standard Deviation 1.6 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Leucocytes: Change from week 0 to week 56 | -0.2 10^9 cells/L | Standard Deviation 1.6 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Leucocytes: Change from week 56 to week 82 | 0.2 10^9 cells/L | Standard Deviation 1.5 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Eosinophils: Change from week 0 to week 30 | 0.03 10^9 cells/L | Standard Deviation 0.15 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Eosinophils: Change from week 0 to week 56 | 0.01 10^9 cells/L | Standard Deviation 0.15 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Eosinophils: Change from week 56 to week 82 | -0.01 10^9 cells/L | Standard Deviation 0.12 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Neutrophils: Change from week 0 to week 30 | 0.18 10^9 cells/L | Standard Deviation 1.33 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Neutrophils: Change from week 0 to week 56 | -0.01 10^9 cells/L | Standard Deviation 1.49 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Neutrophils: Change from week 56 to week 82 | 0.21 10^9 cells/L | Standard Deviation 1.35 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Basophils: Change from week 0 to week 30 | 0.01 10^9 cells/L | Standard Deviation 0.03 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Basophils: Change from week 0 to week 56 | 0.01 10^9 cells/L | Standard Deviation 0.03 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Basophils: Change from week 56 to week 82 | 0.00 10^9 cells/L | Standard Deviation 0.03 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Lymphocytes: Change from week 0 to week 30 | -0.18 10^9 cells/L | Standard Deviation 0.69 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Lymphocytes: Change from week 0 to week 56 | -0.28 10^9 cells/L | Standard Deviation 0.59 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Lymphocytes: Change from week 56 to week 82 | -0.03 10^9 cells/L | Standard Deviation 0.48 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Monocytes: Change from week 0 to week 30 | 0.04 10^9 cells/L | Standard Deviation 0.16 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Monocytes: Change from week 0 to week 56 | 0.06 10^9 cells/L | Standard Deviation 0.13 |
| Liraglutide 3.0 mg | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Monocytes: Change from week 56 to week 82 | -0.00 10^9 cells/L | Standard Deviation 0.15 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Neutrophils: Change from week 0 to week 56 | -0.13 10^9 cells/L | Standard Deviation 1.5 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Thrombocytes: Change from week 0 to week 30 | 14 10^9 cells/L | Standard Deviation 38 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Monocytes: Change from week 0 to week 30 | 0.00 10^9 cells/L | Standard Deviation 0.18 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Thrombocytes: Change from week 0 to week 56 | 7 10^9 cells/L | Standard Deviation 39 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Neutrophils: Change from week 56 to week 82 | -0.00 10^9 cells/L | Standard Deviation 1.71 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Thrombocytes: Change from week 56 to week 82 | 3 10^9 cells/L | Standard Deviation 37 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Lymphocytes: Change from week 0 to week 56 | -0.27 10^9 cells/L | Standard Deviation 0.72 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Leucocytes: Change from week 0 to week 30 | -0.1 10^9 cells/L | Standard Deviation 2 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Basophils: Change from week 0 to week 30 | 0.01 10^9 cells/L | Standard Deviation 0.03 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Leucocytes: Change from week 0 to week 56 | -0.4 10^9 cells/L | Standard Deviation 1.7 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Monocytes: Change from week 56 to week 82 | 0.04 10^9 cells/L | Standard Deviation 0.18 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Leucocytes: Change from week 56 to week 82 | 0.0 10^9 cells/L | Standard Deviation 2 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Basophils: Change from week 0 to week 56 | 0.02 10^9 cells/L | Standard Deviation 0.03 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Eosinophils: Change from week 0 to week 30 | 0.04 10^9 cells/L | Standard Deviation 0.29 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Lymphocytes: Change from week 56 to week 82 | -0.00 10^9 cells/L | Standard Deviation 0.61 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Eosinophils: Change from week 0 to week 56 | 0.00 10^9 cells/L | Standard Deviation 0.23 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Basophils: Change from week 56 to week 82 | 0.00 10^9 cells/L | Standard Deviation 0.03 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Eosinophils: Change from week 56 to week 82 | 0.00 10^9 cells/L | Standard Deviation 0.15 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Monocytes: Change from week 0 to week 56 | 0.01 10^9 cells/L | Standard Deviation 0.17 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Neutrophils: Change from week 0 to week 30 | -0.01 10^9 cells/L | Standard Deviation 1.71 |
| Placebo | Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes | Lymphocytes: Change from week 0 to week 30 | -0.14 10^9 cells/L | Standard Deviation 0.62 |
Secondary
Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in HbA1c | Change from week 0 to week 30 | -0.1 Percentage of HbA1c | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change in HbA1c | Change from week 0 to week 56 | -0.1 Percentage of HbA1c | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change in HbA1c | Change from week 56 to week 82 | 0.1 Percentage of HbA1c | Standard Deviation 0.2 |
| Placebo | Change in HbA1c | Change from week 0 to week 30 | -0.0 Percentage of HbA1c | Standard Deviation 0.3 |
| Placebo | Change in HbA1c | Change from week 0 to week 56 | -0.0 Percentage of HbA1c | Standard Deviation 0.2 |
| Placebo | Change in HbA1c | Change from week 56 to week 82 | 0.1 Percentage of HbA1c | Standard Deviation 0.3 |
Secondary
Change in Height SDS
Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Height SDS | Change from week 0 to week 30 | 0.11 SDS | Standard Deviation 0.17 |
| Liraglutide 3.0 mg | Change in Height SDS | Change from week 0 to week 56 | 0.20 SDS | Standard Deviation 0.27 |
| Liraglutide 3.0 mg | Change in Height SDS | Change from week 56 to week 82 | 0.07 SDS | Standard Deviation 0.16 |
| Placebo | Change in Height SDS | Change from week 0 to week 56 | 0.24 SDS | Standard Deviation 0.3 |
| Placebo | Change in Height SDS | Change from week 0 to week 30 | 0.13 SDS | Standard Deviation 0.18 |
| Placebo | Change in Height SDS | Change from week 56 to week 82 | 0.06 SDS | Standard Deviation 0.12 |
Secondary
Change in HOMA-B (Ratio to Baseline)
Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin\[mU/L\]/(FPG\[mmol/L\]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in HOMA-B (Ratio to Baseline) | Change from week 0 to week 30 | 1.32 Ratio of HOMA-B | Geometric Coefficient of Variation 70.8 |
| Liraglutide 3.0 mg | Change in HOMA-B (Ratio to Baseline) | Change from week 0 to week 56 | 1.13 Ratio of HOMA-B | Geometric Coefficient of Variation 67 |
| Liraglutide 3.0 mg | Change in HOMA-B (Ratio to Baseline) | Change from week 56 to week 82 | 0.92 Ratio of HOMA-B | Geometric Coefficient of Variation 65.9 |
| Placebo | Change in HOMA-B (Ratio to Baseline) | Change from week 0 to week 30 | 1.17 Ratio of HOMA-B | Geometric Coefficient of Variation 59.5 |
| Placebo | Change in HOMA-B (Ratio to Baseline) | Change from week 0 to week 56 | 1.11 Ratio of HOMA-B | Geometric Coefficient of Variation 58 |
| Placebo | Change in HOMA-B (Ratio to Baseline) | Change from week 56 to week 82 | 1.02 Ratio of HOMA-B | Geometric Coefficient of Variation 50.2 |
Secondary
Change in HOMA-IR (Ratio to Baseline)
Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin \[mU/L\] x FPG \[mmol/L\]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in HOMA-IR (Ratio to Baseline) | Change from week 0 to week 56 | 1.04 Ratio of HOMA-IR | Geometric Coefficient of Variation 75.3 |
| Liraglutide 3.0 mg | Change in HOMA-IR (Ratio to Baseline) | Change from week 0 to week 30 | 1.08 Ratio of HOMA-IR | Geometric Coefficient of Variation 75.2 |
| Liraglutide 3.0 mg | Change in HOMA-IR (Ratio to Baseline) | Change from week 56 to week 82 | 1.03 Ratio of HOMA-IR | Geometric Coefficient of Variation 64.2 |
| Placebo | Change in HOMA-IR (Ratio to Baseline) | Change from week 0 to week 30 | 1.14 Ratio of HOMA-IR | Geometric Coefficient of Variation 55.6 |
| Placebo | Change in HOMA-IR (Ratio to Baseline) | Change from week 0 to week 56 | 1.09 Ratio of HOMA-IR | Geometric Coefficient of Variation 80 |
| Placebo | Change in HOMA-IR (Ratio to Baseline) | Change from week 56 to week 82 | 1.11 Ratio of HOMA-IR | Geometric Coefficient of Variation 60.5 |
Secondary
Change in Hormone Level: Calcitonin
Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: Calcitonin | Change from week 0 to week 56 | 0.0 ng/L | Standard Deviation 0.7 |
| Liraglutide 3.0 mg | Change in Hormone Level: Calcitonin | Change from week 0 to week 30 | 0.1 ng/L | Standard Deviation 0.8 |
| Liraglutide 3.0 mg | Change in Hormone Level: Calcitonin | Change from week 56 to week 82 | -0.1 ng/L | Standard Deviation 0.6 |
| Placebo | Change in Hormone Level: Calcitonin | Change from week 0 to week 30 | 0.1 ng/L | Standard Deviation 0.7 |
| Placebo | Change in Hormone Level: Calcitonin | Change from week 56 to week 82 | 0.2 ng/L | Standard Deviation 1.5 |
| Placebo | Change in Hormone Level: Calcitonin | Change from week 0 to week 56 | -0.0 ng/L | Standard Deviation 0.8 |
Secondary
Change in Hormone Level: DHEAS
Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: DHEAS | Change from week 0 to week 30 | 0.94 umol/L | Standard Deviation 1.66 |
| Liraglutide 3.0 mg | Change in Hormone Level: DHEAS | Change from week 0 to week 56 | 0.95 umol/L | Standard Deviation 1.91 |
| Liraglutide 3.0 mg | Change in Hormone Level: DHEAS | Change from week 56 to week 82 | -0.08 umol/L | Standard Deviation 2.11 |
| Placebo | Change in Hormone Level: DHEAS | Change from week 0 to week 30 | 0.57 umol/L | Standard Deviation 1.78 |
| Placebo | Change in Hormone Level: DHEAS | Change from week 0 to week 56 | 0.89 umol/L | Standard Deviation 2.05 |
| Placebo | Change in Hormone Level: DHEAS | Change from week 56 to week 82 | -0.05 umol/L | Standard Deviation 1.27 |
Secondary
Change in Hormone Level: Estradiol (Females)
Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: Estradiol (Females) | Change from week 56 to week 82 | -2.3 pg/mL | Standard Deviation 89.1 |
| Liraglutide 3.0 mg | Change in Hormone Level: Estradiol (Females) | Change from week 0 to week 30 | -5.0 pg/mL | Standard Deviation 81 |
| Liraglutide 3.0 mg | Change in Hormone Level: Estradiol (Females) | Change from week 0 to week 56 | 11.6 pg/mL | Standard Deviation 94.4 |
| Placebo | Change in Hormone Level: Estradiol (Females) | Change from week 56 to week 82 | -1.7 pg/mL | Standard Deviation 65.3 |
| Placebo | Change in Hormone Level: Estradiol (Females) | Change from week 0 to week 30 | 20.2 pg/mL | Standard Deviation 67.6 |
| Placebo | Change in Hormone Level: Estradiol (Females) | Change from week 0 to week 56 | 14.1 pg/mL | Standard Deviation 63.6 |
Secondary
Change in Hormone Level: Free T4 and ACTH
Change in hormone levels, thyroxine (T4) and adrenocorticotropic hormone (ACTH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: Free T4 and ACTH | ACTH: Change from week 0 to week 56 | 0.6 pmol/L | Standard Deviation 4.9 |
| Liraglutide 3.0 mg | Change in Hormone Level: Free T4 and ACTH | ACTH: Change from week 56 to week 82 | -0.8 pmol/L | Standard Deviation 4.7 |
| Liraglutide 3.0 mg | Change in Hormone Level: Free T4 and ACTH | T4: Change from week 0 to week 30 | 0.6 pmol/L | Standard Deviation 1.9 |
| Liraglutide 3.0 mg | Change in Hormone Level: Free T4 and ACTH | T4: Change from week 0 to week 56 | 0.3 pmol/L | Standard Deviation 1.8 |
| Liraglutide 3.0 mg | Change in Hormone Level: Free T4 and ACTH | T4: Change from week 56 to week 82 | 0.0 pmol/L | Standard Deviation 1.6 |
| Liraglutide 3.0 mg | Change in Hormone Level: Free T4 and ACTH | ACTH: Change from week 0 to week 30 | 0.4 pmol/L | Standard Deviation 4.4 |
| Placebo | Change in Hormone Level: Free T4 and ACTH | T4: Change from week 56 to week 82 | 0.2 pmol/L | Standard Deviation 2.3 |
| Placebo | Change in Hormone Level: Free T4 and ACTH | ACTH: Change from week 0 to week 56 | 0.6 pmol/L | Standard Deviation 3.8 |
| Placebo | Change in Hormone Level: Free T4 and ACTH | T4: Change from week 0 to week 56 | 0.6 pmol/L | Standard Deviation 2.1 |
| Placebo | Change in Hormone Level: Free T4 and ACTH | ACTH: Change from week 56 to week 82 | -0.4 pmol/L | Standard Deviation 2.9 |
| Placebo | Change in Hormone Level: Free T4 and ACTH | ACTH: Change from week 0 to week 30 | 0.5 pmol/L | Standard Deviation 3.9 |
| Placebo | Change in Hormone Level: Free T4 and ACTH | T4: Change from week 0 to week 30 | 0.8 pmol/L | Standard Deviation 2.1 |
Secondary
Change in Hormone Level: IGF-1 and Cortisol
Change in hormone levels, insulin-like growth factor-1 (IGF-1) and cortisol was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: IGF-1 and Cortisol | IGF-1: Change from week 0 to week 30 | 10.61 ng/mL | Standard Deviation 89.83 |
| Liraglutide 3.0 mg | Change in Hormone Level: IGF-1 and Cortisol | IGF-1: Change from week 0 to week 56 | -4.60 ng/mL | Standard Deviation 84.51 |
| Liraglutide 3.0 mg | Change in Hormone Level: IGF-1 and Cortisol | Cortisol: Change from week 0 to week 56 | 5.1 ng/mL | Standard Deviation 65.2 |
| Liraglutide 3.0 mg | Change in Hormone Level: IGF-1 and Cortisol | IGF-1: Change from week 56 to week 82 | -14.60 ng/mL | Standard Deviation 80.82 |
| Liraglutide 3.0 mg | Change in Hormone Level: IGF-1 and Cortisol | Cortisol: Change from week 0 to week 30 | 6.9 ng/mL | Standard Deviation 66.9 |
| Liraglutide 3.0 mg | Change in Hormone Level: IGF-1 and Cortisol | Cortisol: Change from week 56 to week 82 | 0.6 ng/mL | Standard Deviation 66.6 |
| Placebo | Change in Hormone Level: IGF-1 and Cortisol | Cortisol: Change from week 56 to week 82 | 10.4 ng/mL | Standard Deviation 61.2 |
| Placebo | Change in Hormone Level: IGF-1 and Cortisol | IGF-1: Change from week 0 to week 30 | 3.79 ng/mL | Standard Deviation 101.12 |
| Placebo | Change in Hormone Level: IGF-1 and Cortisol | IGF-1: Change from week 0 to week 56 | 3.69 ng/mL | Standard Deviation 111.63 |
| Placebo | Change in Hormone Level: IGF-1 and Cortisol | IGF-1: Change from week 56 to week 82 | -16.35 ng/mL | Standard Deviation 65.89 |
| Placebo | Change in Hormone Level: IGF-1 and Cortisol | Cortisol: Change from week 0 to week 30 | 8.6 ng/mL | Standard Deviation 60.1 |
| Placebo | Change in Hormone Level: IGF-1 and Cortisol | Cortisol: Change from week 0 to week 56 | 8.5 ng/mL | Standard Deviation 57.9 |
Secondary
Change in Hormone Level: LH and FSH
Change in hormone levels, luteinising hormone (LH) and follicle stimulating hormone (FSH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: LH and FSH | FSH: Change from week 56 to week 82 | -0.1 IU/L | Standard Deviation 3.6 |
| Liraglutide 3.0 mg | Change in Hormone Level: LH and FSH | LH: Change from week 0 to week 30 | 0.4 IU/L | Standard Deviation 9.1 |
| Liraglutide 3.0 mg | Change in Hormone Level: LH and FSH | LH: Change from week 56 to week 82 | 0.4 IU/L | Standard Deviation 8.7 |
| Liraglutide 3.0 mg | Change in Hormone Level: LH and FSH | FSH: Change from week 0 to week 30 | 0.2 IU/L | Standard Deviation 2.6 |
| Liraglutide 3.0 mg | Change in Hormone Level: LH and FSH | FSH: Change from week 0 to week 56 | 0.6 IU/L | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change in Hormone Level: LH and FSH | LH: Change from week 0 to week 56 | 0.2 IU/L | Standard Deviation 9.1 |
| Placebo | Change in Hormone Level: LH and FSH | FSH: Change from week 56 to week 82 | -0.1 IU/L | Standard Deviation 3.1 |
| Placebo | Change in Hormone Level: LH and FSH | LH: Change from week 0 to week 56 | 0.6 IU/L | Standard Deviation 6.6 |
| Placebo | Change in Hormone Level: LH and FSH | LH: Change from week 56 to week 82 | -0.5 IU/L | Standard Deviation 8 |
| Placebo | Change in Hormone Level: LH and FSH | FSH: Change from week 0 to week 56 | 0.1 IU/L | Standard Deviation 2.5 |
| Placebo | Change in Hormone Level: LH and FSH | FSH: Change from week 0 to week 30 | -0.2 IU/L | Standard Deviation 2.7 |
| Placebo | Change in Hormone Level: LH and FSH | LH: Change from week 0 to week 30 | 0.7 IU/L | Standard Deviation 7.9 |
Secondary
Change in Hormone Level: Testosterone (Males)
This outcome measure presents testosterone (only for males) results for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: Week 0, week 30, week 56 and week 82
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: Testosterone (Males) | Week 0 | 8.13 nmol/L | Standard Deviation 3.45 |
| Liraglutide 3.0 mg | Change in Hormone Level: Testosterone (Males) | Week 56 | 10.55 nmol/L | Standard Deviation 4.14 |
| Liraglutide 3.0 mg | Change in Hormone Level: Testosterone (Males) | Week 30 | 10.00 nmol/L | Standard Deviation 4.02 |
| Liraglutide 3.0 mg | Change in Hormone Level: Testosterone (Males) | Week 82 | 11.36 nmol/L | Standard Deviation 5.27 |
| Placebo | Change in Hormone Level: Testosterone (Males) | Week 82 | 6.16 nmol/L | Standard Deviation 3.27 |
| Placebo | Change in Hormone Level: Testosterone (Males) | Week 0 | 8.06 nmol/L | Standard Deviation 3.66 |
| Placebo | Change in Hormone Level: Testosterone (Males) | Week 30 | 9.33 nmol/L | Standard Deviation 5.27 |
| Placebo | Change in Hormone Level: Testosterone (Males) | Week 56 | 9.51 nmol/L | Standard Deviation 3.31 |
Secondary
Change in Hormone Level: TSH and Prolactin
Change in hormone levels, thyroid stimulating hormone (TSH) and prolactin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Hormone Level: TSH and Prolactin | TSH: Change from week 56 to week 82 | 0.38 mIU/L | Standard Deviation 1.91 |
| Liraglutide 3.0 mg | Change in Hormone Level: TSH and Prolactin | Prolactin: Change from week 0 to week 30 | 23 mIU/L | Standard Deviation 165 |
| Liraglutide 3.0 mg | Change in Hormone Level: TSH and Prolactin | Prolactin: Change from week 0 to week 56 | 63 mIU/L | Standard Deviation 312 |
| Liraglutide 3.0 mg | Change in Hormone Level: TSH and Prolactin | TSH: Change from week 0 to week 30 | -0.35 mIU/L | Standard Deviation 1.37 |
| Liraglutide 3.0 mg | Change in Hormone Level: TSH and Prolactin | TSH: Change from week 0 to week 56 | -0.42 mIU/L | Standard Deviation 1.36 |
| Liraglutide 3.0 mg | Change in Hormone Level: TSH and Prolactin | Prolactin: Change from week 56 to week 82 | -29 mIU/L | Standard Deviation 396 |
| Placebo | Change in Hormone Level: TSH and Prolactin | Prolactin: Change from week 56 to week 82 | 13 mIU/L | Standard Deviation 98 |
| Placebo | Change in Hormone Level: TSH and Prolactin | TSH: Change from week 0 to week 56 | -0.14 mIU/L | Standard Deviation 1.28 |
| Placebo | Change in Hormone Level: TSH and Prolactin | Prolactin: Change from week 0 to week 30 | -47 mIU/L | Standard Deviation 452 |
| Placebo | Change in Hormone Level: TSH and Prolactin | TSH: Change from week 56 to week 82 | 0.13 mIU/L | Standard Deviation 1.57 |
| Placebo | Change in Hormone Level: TSH and Prolactin | Prolactin: Change from week 0 to week 56 | -63 mIU/L | Standard Deviation 684 |
| Placebo | Change in Hormone Level: TSH and Prolactin | TSH: Change from week 0 to week 30 | -0.08 mIU/L | Standard Deviation 1.17 |
Secondary
Change in hsCRP
Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the safety analysis set (SAS) which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in hsCRP | Change from week 56 to week 82 | 1.51 mg/L | Standard Deviation 7.61 |
| Liraglutide 3.0 mg | Change in hsCRP | Change from week 0 to week 30 | -0.22 mg/L | Standard Deviation 5.04 |
| Liraglutide 3.0 mg | Change in hsCRP | Change from week 0 to week 56 | -0.25 mg/L | Standard Deviation 4.54 |
| Placebo | Change in hsCRP | Change from week 0 to week 56 | -0.14 mg/L | Standard Deviation 3.44 |
| Placebo | Change in hsCRP | Change from week 0 to week 30 | -0.56 mg/L | Standard Deviation 4.68 |
| Placebo | Change in hsCRP | Change from week 56 to week 82 | 1.00 mg/L | Standard Deviation 4.22 |
Secondary
Change in IWQOL-Kids
Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Family Relation: Change from week 0 to week 30 | 2.53 Scores on a scale | Standard Deviation 9.66 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Physical Function: Change from week 0 to week 56 | 6.17 Scores on a scale | Standard Deviation 15.44 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Body Esteem: Change from week 0 to week 56 | 13.33 Scores on a scale | Standard Deviation 19.47 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Social Life: Change from week 0 to week 30 | 5.32 Scores on a scale | Standard Deviation 10.56 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Family Relation: Change from week 0 to week 56 | 1.44 Scores on a scale | Standard Deviation 14.31 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Body Esteem: Change from week 0 to week 30 | 10.62 Scores on a scale | Standard Deviation 19.88 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Total: Change from week 0 to week 30 | 6.16 Scores on a scale | Standard Deviation 11.04 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Physical Function: Change from week 0 to week 30 | 3.94 Scores on a scale | Standard Deviation 15.34 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Total: Change from week 0 to week 56 | 7.46 Scores on a scale | Standard Deviation 13.7 |
| Liraglutide 3.0 mg | Change in IWQOL-Kids | Social Life: Change from week 0 to week 56 | 5.97 Scores on a scale | Standard Deviation 19.48 |
| Placebo | Change in IWQOL-Kids | Total: Change from week 0 to week 56 | 6.72 Scores on a scale | Standard Deviation 11.62 |
| Placebo | Change in IWQOL-Kids | Body Esteem: Change from week 0 to week 30 | 6.73 Scores on a scale | Standard Deviation 26.87 |
| Placebo | Change in IWQOL-Kids | Body Esteem: Change from week 0 to week 56 | 13.24 Scores on a scale | Standard Deviation 22.72 |
| Placebo | Change in IWQOL-Kids | Family Relation: Change from week 0 to week 30 | -2.19 Scores on a scale | Standard Deviation 17.53 |
| Placebo | Change in IWQOL-Kids | Family Relation: Change from week 0 to week 56 | 0.97 Scores on a scale | Standard Deviation 5.61 |
| Placebo | Change in IWQOL-Kids | Physical Function: Change from week 0 to week 30 | 0.43 Scores on a scale | Standard Deviation 22.02 |
| Placebo | Change in IWQOL-Kids | Physical Function: Change from week 0 to week 56 | 3.32 Scores on a scale | Standard Deviation 16.6 |
| Placebo | Change in IWQOL-Kids | Social Life: Change from week 0 to week 30 | 1.76 Scores on a scale | Standard Deviation 21.98 |
| Placebo | Change in IWQOL-Kids | Social Life: Change from week 0 to week 56 | 6.06 Scores on a scale | Standard Deviation 14.04 |
| Placebo | Change in IWQOL-Kids | Total: Change from week 0 to week 30 | 2.24 Scores on a scale | Standard Deviation 19.69 |
Secondary
Change in NTX1
Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in nmol bone collagen equivalents (BCE)/L. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in NTX1 | Change from week 56 to week 82 | -2.8 nmol BCE/L | Standard Deviation 12.8 |
| Liraglutide 3.0 mg | Change in NTX1 | Change from week 0 to week 30 | -2.4 nmol BCE/L | Standard Deviation 10.4 |
| Liraglutide 3.0 mg | Change in NTX1 | Change from week 0 to week 56 | -3.7 nmol BCE/L | Standard Deviation 14.1 |
| Placebo | Change in NTX1 | Change from week 0 to week 56 | -2.9 nmol BCE/L | Standard Deviation 15.1 |
| Placebo | Change in NTX1 | Change from week 56 to week 82 | -4.6 nmol BCE/L | Standard Deviation 10 |
| Placebo | Change in NTX1 | Change from week 0 to week 30 | -3.2 nmol BCE/L | Standard Deviation 12 |
Secondary
Change in Nutritional Compliance
This outcome measure presents nutritional compliance results recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time frame: Week 0, week 30 and week 56
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat \[ITT\] principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Nutritional Compliance | Week 0 | 7.10 Score on a scale | Standard Deviation 1.74 |
| Liraglutide 3.0 mg | Change in Nutritional Compliance | Week 30 | 6.74 Score on a scale | Standard Deviation 2.08 |
| Liraglutide 3.0 mg | Change in Nutritional Compliance | Week 56 | 6.87 Score on a scale | Standard Deviation 1.87 |
| Placebo | Change in Nutritional Compliance | Week 0 | 7.07 Score on a scale | Standard Deviation 1.69 |
| Placebo | Change in Nutritional Compliance | Week 30 | 6.51 Score on a scale | Standard Deviation 1.91 |
| Placebo | Change in Nutritional Compliance | Week 56 | 6.45 Score on a scale | Standard Deviation 1.84 |
Secondary
Change in P1NP
Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in P1NP | Change from week 0 to week 56 | -55 ng/mL | Standard Deviation 151 |
| Liraglutide 3.0 mg | Change in P1NP | Change from week 0 to week 30 | -35 ng/mL | Standard Deviation 124 |
| Liraglutide 3.0 mg | Change in P1NP | Change from week 56 to week 82 | -30 ng/mL | Standard Deviation 107 |
| Placebo | Change in P1NP | Change from week 0 to week 30 | -30 ng/mL | Standard Deviation 184 |
| Placebo | Change in P1NP | Change from week 0 to week 56 | -63 ng/mL | Standard Deviation 192 |
| Placebo | Change in P1NP | Change from week 56 to week 82 | -47 ng/mL | Standard Deviation 84 |
Secondary
Change in PHQ-9
Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. 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. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in PHQ-9 | Change from week 0 to week 30 | -1 Score on a scale | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change in PHQ-9 | Change from week 0 to week 56 | -1 Score on a scale | Standard Deviation 3 |
| Liraglutide 3.0 mg | Change in PHQ-9 | Change from week 56 to week 82 | 0 Score on a scale | Standard Deviation 2 |
| Placebo | Change in PHQ-9 | Change from week 0 to week 30 | -1 Score on a scale | Standard Deviation 4 |
| Placebo | Change in PHQ-9 | Change from week 0 to week 56 | -2 Score on a scale | Standard Deviation 3 |
| Placebo | Change in PHQ-9 | Change from week 56 to week 82 | -0 Score on a scale | Standard Deviation 3 |
Secondary
Change in Physical Examination
This outcome measure presents number of subjects with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 30, week 56 and week 82. 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. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: Week 0, week 30, week 56 and week 82
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 82 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 30 | Abnormal, NCS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 0 | Normal | 119 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 0 | Abnormal, NCS | 30 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 0 | Abnormal, NCS | 5 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 56 | Normal | 101 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 0 | Abnormal, CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 82 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 30 | Normal | 111 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 56 | Abnormal, NCS | 3 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 30 | Abnormal, NCS | 5 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 0 | Abnormal, CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 56 | Normal | 102 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 56 | Abnormal, NCS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 82 | Normal | 98 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 30 | Normal | 94 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 82 | Normal | 96 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 30 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 82 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 82 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | GI system including mouth: Week 82 | Abnormal, CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 30 | Abnormal, NCS | 21 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 0 | Normal | 121 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 0 | Normal | 125 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 0 | Abnormal, NCS | 4 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 0 | Abnormal, NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 30 | Normal | 113 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 30 | Abnormal, CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 30 | Abnormal, NCS | 3 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 56 | Normal | 102 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 30 | Normal | 116 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 56 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 56 | Normal | 84 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 56 | Abnormal, CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 30 | Abnormal, NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 82 | Normal | 97 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 0 | Normal | 124 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 82 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Musculoskeletal system: Week 82 | Abnormal, CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 56 | Abnormal, NCS | 18 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 0 | Normal | 124 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 56 | Normal | 104 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 0 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 56 | Normal | 103 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 56 | Abnormal, NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 30 | Normal | 115 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 56 | Abnormal, CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 30 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 82 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 56 | Normal | 104 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 82 | Normal | 99 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 56 | Abnormal, NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 82 | Normal | 80 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 82 | Abnormal, NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 82 | Normal | 99 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 56 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 82 | Abnormal, NCS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Respiratory system: Week 82 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | CNS and PNS: Week 82 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 82 | Abnormal, NCS | 18 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 0 | Normal | 76 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 0 | Normal | 124 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 0 | Abnormal, NCS | 47 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 82 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 0 | Abnormal, CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 82 | Abnormal, CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 30 | Normal | 71 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 0 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 30 | Abnormal, NCS | 44 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 30 | Abnormal, CS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 56 | Normal | 65 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 120 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 56 | Abnormal, NCS | 35 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 30 | Normal | 115 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 56 | Abnormal, CS | 4 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 30 | Normal | 115 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 82 | Normal | 57 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 30 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 82 | Abnormal, NCS | 40 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 5 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Skin: Week 82 | Abnormal, CS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 0 | Normal | 124 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 82 | Normal | 98 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 0 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 56 | Normal | 102 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 30 | Normal | 115 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 56 | Abnormal, NCS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 30 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | General Appearance: Week 0 | Normal | 93 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 30 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 56 | Normal | 103 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 82 | Normal | 97 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 56 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 30 | Normal | 114 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 56 | Abnormal, CS | 0 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Cardiovascular system: Week 82 | Abnormal, NCS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 82 | Normal | 97 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Lymph node palpation: Week 0 | Abnormal, NCS | 1 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 82 | Abnormal, NCS | 2 Participants |
| Liraglutide 3.0 mg | Change in Physical Examination | Thyroid gland: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 82 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 82 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 0 | Normal | 125 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 0 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 82 | Normal | 98 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 30 | Normal | 116 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 30 | Abnormal, NCS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 56 | Normal | 102 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 56 | Abnormal, NCS | 0 Participants |
| Placebo | Change in Physical Examination | Lymph node palpation: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 0 | Normal | 101 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 0 | Abnormal, NCS | 23 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 0 | Abnormal, CS | 2 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 30 | Normal | 95 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 30 | Abnormal, NCS | 20 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 30 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 56 | Normal | 85 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 56 | Abnormal, NCS | 16 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 56 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 82 | Normal | 81 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 82 | Abnormal, NCS | 17 Participants |
| Placebo | Change in Physical Examination | General Appearance: Week 82 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 0 | Normal | 116 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, NCS | 10 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 30 | Normal | 107 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 30 | Abnormal, NCS | 9 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 56 | Normal | 98 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 56 | Abnormal, NCS | 4 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 82 | Normal | 94 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 82 | Abnormal, NCS | 5 Participants |
| Placebo | Change in Physical Examination | Head, ears, eyes, nose, throat, neck: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 0 | Normal | 123 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 0 | Abnormal, NCS | 3 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 30 | Normal | 115 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 30 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 56 | Normal | 101 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 56 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 82 | Normal | 96 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 82 | Abnormal, NCS | 3 Participants |
| Placebo | Change in Physical Examination | Respiratory system: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 0 | Normal | 125 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 0 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 30 | Normal | 112 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 30 | Abnormal, NCS | 4 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 56 | Normal | 100 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 56 | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 82 | Normal | 98 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 82 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Cardiovascular system: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 0 | Normal | 119 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 0 | Abnormal, NCS | 6 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 0 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 30 | Normal | 109 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 30 | Abnormal, NCS | 6 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 30 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 56 | Normal | 98 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 56 | Abnormal, NCS | 4 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 82 | Normal | 94 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 82 | Abnormal, NCS | 5 Participants |
| Placebo | Change in Physical Examination | GI system including mouth: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 0 | Normal | 119 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 0 | Abnormal, NCS | 7 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 30 | Normal | 106 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 30 | Abnormal, NCS | 10 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 56 | Normal | 97 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 56 | Abnormal, NCS | 5 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 82 | Normal | 92 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 82 | Abnormal, NCS | 7 Participants |
| Placebo | Change in Physical Examination | Musculoskeletal system: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 0 | Normal | 124 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 0 | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 30 | Normal | 115 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 30 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 56 | Normal | 101 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 56 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 82 | Normal | 98 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 82 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | CNS and PNS: Week 82 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Skin: Week 0 | Normal | 58 Participants |
| Placebo | Change in Physical Examination | Skin: Week 0 | Abnormal, NCS | 64 Participants |
| Placebo | Change in Physical Examination | Skin: Week 0 | Abnormal, CS | 4 Participants |
| Placebo | Change in Physical Examination | Skin: Week 30 | Normal | 56 Participants |
| Placebo | Change in Physical Examination | Skin: Week 30 | Abnormal, NCS | 56 Participants |
| Placebo | Change in Physical Examination | Skin: Week 30 | Abnormal, CS | 4 Participants |
| Placebo | Change in Physical Examination | Skin: Week 56 | Normal | 48 Participants |
| Placebo | Change in Physical Examination | Skin: Week 56 | Abnormal, NCS | 53 Participants |
| Placebo | Change in Physical Examination | Skin: Week 56 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | Skin: Week 82 | Normal | 50 Participants |
| Placebo | Change in Physical Examination | Skin: Week 82 | Abnormal, NCS | 48 Participants |
| Placebo | Change in Physical Examination | Skin: Week 82 | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 0 | Normal | 124 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 0 | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 0 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 30 | Normal | 114 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 30 | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 30 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 56 | Normal | 101 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 56 | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 56 | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination | Thyroid gland: Week 82 | Normal | 98 Participants |
Secondary
Change in Pubertal Status
This outcome measure presents pubertal status results which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: penis development (male) | Stage 2 | 4 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 3 | 6 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: penis development (male) | Stage 3 | 11 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 4 | 7 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: penis development (male) | Stage 4 | 16 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: penis development (male) | Stage 5 | 23 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 5 | 46 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 3 | 4 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: penis development (male) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 2 | 2 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: penis development (male) | Stage 3 | 11 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: penis development (male) | Stage 4 | 14 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 2 | 2 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: penis development (male) | Stage 5 | 25 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 4 | 22 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: penis development (male) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 4 | 22 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: penis development (male) | Stage 3 | 6 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 3 | 6 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: penis development (male) | Stage 4 | 15 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 5 | 41 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: penis development (male) | Stage 5 | 26 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 5 | 39 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: penis development (male) | Stage 2 | 0 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: penis development (male) | Stage 3 | 3 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 3 | 4 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: penis development (male) | Stage 4 | 11 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 2 | 0 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: penis development (male) | Stage 5 | 31 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 4 | 20 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 2 | 6 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 4 | 14 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 3 | 8 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 5 | 41 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 4 | 19 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 4 | 23 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 5 | 21 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 5 | 41 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 4 | 13 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 3 | 10 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 5 | 41 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 4 | 15 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 5 | 24 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 2 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 3 | 7 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 3 | 2 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 4 | 15 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 3 | 1 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 5 | 24 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 2 | 0 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 2 | 0 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 4 | 7 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 3 | 3 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 5 | 40 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 4 | 10 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 5 | 45 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 5 | 30 Participants |
| Liraglutide 3.0 mg | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 3 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 5 | 28 Participants |
| Placebo | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 3 | 2 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 3 | 4 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 3 | 8 Participants |
| Placebo | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 4 | 30 Participants |
| Placebo | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 5 | 39 Participants |
| Placebo | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 3 | 6 Participants |
| Placebo | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 4 | 25 Participants |
| Placebo | Change in Pubertal Status | Week 30: Breast development (for female) | Stage 5 | 43 Participants |
| Placebo | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 4 | 20 Participants |
| Placebo | Change in Pubertal Status | Week 56: Breast development (for female) | Stage 5 | 41 Participants |
| Placebo | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 3 | 2 Participants |
| Placebo | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 4 | 13 Participants |
| Placebo | Change in Pubertal Status | Week 82: Breast development (for female) | Stage 5 | 46 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 2 | 3 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 3 | 5 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 4 | 26 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (for female) | Stage 5 | 44 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 4 | 21 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 4 | 25 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (for female) | Stage 5 | 45 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (for female) | Stage 5 | 40 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 3 | 2 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 4 | 14 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (for female) | Stage 5 | 45 Participants |
| Placebo | Change in Pubertal Status | Week 0: penis development (male) | Stage 2 | 7 Participants |
| Placebo | Change in Pubertal Status | Week 0: penis development (male) | Stage 3 | 8 Participants |
| Placebo | Change in Pubertal Status | Week 0: penis development (male) | Stage 4 | 14 Participants |
| Placebo | Change in Pubertal Status | Week 0: penis development (male) | Stage 5 | 19 Participants |
| Placebo | Change in Pubertal Status | Week 30: penis development (male) | Stage 3 | 7 Participants |
| Placebo | Change in Pubertal Status | Week 30: penis development (male) | Stage 2 | 2 Participants |
| Placebo | Change in Pubertal Status | Week 30: penis development (male) | Stage 4 | 11 Participants |
| Placebo | Change in Pubertal Status | Week 30: penis development (male) | Stage 5 | 25 Participants |
| Placebo | Change in Pubertal Status | Week 56: penis development (male) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 56: penis development (male) | Stage 3 | 6 Participants |
| Placebo | Change in Pubertal Status | Week 56: penis development (male) | Stage 4 | 6 Participants |
| Placebo | Change in Pubertal Status | Week 56: penis development (male) | Stage 5 | 29 Participants |
| Placebo | Change in Pubertal Status | Week 82: penis development (male) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 82: penis development (male) | Stage 3 | 3 Participants |
| Placebo | Change in Pubertal Status | Week 82: penis development (male) | Stage 4 | 6 Participants |
| Placebo | Change in Pubertal Status | Week 82: penis development (male) | Stage 5 | 29 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 2 | 9 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 3 | 5 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 4 | 13 Participants |
| Placebo | Change in Pubertal Status | Week 0: Pubic hair development (male) | Stage 5 | 21 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 5 | 26 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 2 | 3 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 3 | 7 Participants |
| Placebo | Change in Pubertal Status | Week 30: Pubic hair development (male) | Stage 4 | 9 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 3 | 6 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 4 | 7 Participants |
| Placebo | Change in Pubertal Status | Week 56: Pubic hair development (male) | Stage 5 | 28 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 2 | 0 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 3 | 2 Participants |
| Placebo | Change in Pubertal Status | Week 82: Pubic hair development (male) | Stage 4 | 8 Participants |
| Placebo | Change in Pubertal Status | Week 0: Breast development (for female) | Stage 2 | 1 Participants |
Secondary
Change in Pulse
Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Pulse | Change from week 0 to week 30 | 4 Beats/minute | Standard Deviation 12 |
| Liraglutide 3.0 mg | Change in Pulse | Change from week 0 to week 56 | 4 Beats/minute | Standard Deviation 11 |
| Liraglutide 3.0 mg | Change in Pulse | Change from week 56 to week 82 | -3 Beats/minute | Standard Deviation 9 |
| Placebo | Change in Pulse | Change from week 0 to week 30 | -1 Beats/minute | Standard Deviation 12 |
| Placebo | Change in Pulse | Change from week 0 to week 56 | -1 Beats/minute | Standard Deviation 12 |
| Placebo | Change in Pulse | Change from week 56 to week 82 | 2 Beats/minute | Standard Deviation 11 |
Secondary
Change in Systolic and Diastolic Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Systolic and Diastolic Blood Pressure | DBP: Change from week 56 to week 82 | 2 mmHg | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Systolic and Diastolic Blood Pressure | SBP: Change from week 0 to week 30 | -2 mmHg | Standard Deviation 9 |
| Liraglutide 3.0 mg | Change in Systolic and Diastolic Blood Pressure | SBP: Change from week 0 to week 56 | -2 mmHg | Standard Deviation 10 |
| Liraglutide 3.0 mg | Change in Systolic and Diastolic Blood Pressure | SBP: Change from week 56 to week 82 | 2 mmHg | Standard Deviation 9 |
| Liraglutide 3.0 mg | Change in Systolic and Diastolic Blood Pressure | DBP: Change from week 0 to week 30 | -0 mmHg | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Systolic and Diastolic Blood Pressure | DBP: Change from week 0 to week 56 | 1 mmHg | Standard Deviation 9 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | DBP: Change from week 0 to week 30 | -1 mmHg | Standard Deviation 10 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | DBP: Change from week 0 to week 56 | -1 mmHg | Standard Deviation 9 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | SBP: Change from week 56 to week 82 | 1 mmHg | Standard Deviation 10 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | SBP: Change from week 0 to week 30 | -1 mmHg | Standard Deviation 10 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | DBP: Change from week 56 to week 82 | 2 mmHg | Standard Deviation 7 |
| Placebo | Change in Systolic and Diastolic Blood Pressure | SBP: Change from week 0 to week 56 | 1 mmHg | Standard Deviation 10 |
Secondary
Change in Waist Circumference
Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Waist Circumference | Change from week 56 to week 82 | 3.58 cm | Standard Deviation 4.3 |
| Liraglutide 3.0 mg | Change in Waist Circumference | Change from week 0 to week 30 | -4.63 cm | Standard Deviation 6.24 |
| Liraglutide 3.0 mg | Change in Waist Circumference | Change from week 0 to week 56 | -5.12 cm | Standard Deviation 7.87 |
| Placebo | Change in Waist Circumference | Change from week 0 to week 30 | -2.01 cm | Standard Deviation 5.94 |
| Placebo | Change in Waist Circumference | Change from week 0 to week 56 | -1.51 cm | Standard Deviation 8.2 |
| Placebo | Change in Waist Circumference | Change from week 56 to week 82 | 1.24 cm | Standard Deviation 5.6 |
Secondary
Change in Waist-to-hip Circumference Ratio
Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time frame: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide 3.0 mg | Change in Waist-to-hip Circumference Ratio | Change from week 0 to week 30 | -0.015 Ratio | Standard Deviation 0.042 |
| Liraglutide 3.0 mg | Change in Waist-to-hip Circumference Ratio | Change from week 0 to week 56 | -0.022 Ratio | Standard Deviation 0.053 |
| Liraglutide 3.0 mg | Change in Waist-to-hip Circumference Ratio | Change from week 56 to week 82 | 0.010 Ratio | Standard Deviation 0.031 |
| Placebo | Change in Waist-to-hip Circumference Ratio | Change from week 0 to week 30 | -0.018 Ratio | Standard Deviation 0.042 |
| Placebo | Change in Waist-to-hip Circumference Ratio | Change from week 0 to week 56 | -0.023 Ratio | Standard Deviation 0.051 |
| Placebo | Change in Waist-to-hip Circumference Ratio | Change from week 56 to week 82 | 0.003 Ratio | Standard Deviation 0.049 |
Secondary
Number of Treatment Emergent Adverse Events
A treatment emergent adverse event (TEAE) was defined as an event that occurred in the on-treatment period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).
Time frame: Week 0-56 + 14 days
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liraglutide 3.0 mg | Number of Treatment Emergent Adverse Events | 777 Events |
| Placebo | Number of Treatment Emergent Adverse Events | 627 Events |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)
A hypoglycaemic episode was 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 episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.
Time frame: Week 0-56 + 14 days
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Probable symptomatic hypoglycaemia | 1 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Severe hypoglycaemia | 0 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Pseudo-hypoglycaemia | 30 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Documented symptomatic hypoglycaemia | 31 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Unclassifiable | 4 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Asymptomatic hypoglycaemia | 12 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Unclassifiable | 0 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Asymptomatic hypoglycaemia | 17 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Documented symptomatic hypoglycaemia | 6 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Probable symptomatic hypoglycaemia | 2 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Pseudo-hypoglycaemia | 3 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification) | Severe hypoglycaemia | 0 Episodes |
Secondary
Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)
Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Time frame: Week 0-56 + 14 days
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Severe hypoglycaemia | 0 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Asymptomatic BG-confirmed hypoglycaemia | 1 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Symptomatic BG-confirmed hypoglycaemia | 4 Episodes |
| Liraglutide 3.0 mg | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Unclassifiable | 73 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Unclassifiable | 27 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Severe hypoglycaemia | 0 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Symptomatic BG-confirmed hypoglycaemia | 0 Episodes |
| Placebo | Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification) | Asymptomatic BG-confirmed hypoglycaemia | 1 Episodes |
Secondary
Occurrence of Anti-liraglutide Antibodies
This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.
Time frame: Weeks 0, 30, 56, 58, 70 and 82
Population: Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = SAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide 3.0 mg | Occurrence of Anti-liraglutide Antibodies | Weeks 82 | 2 Participants |
| Liraglutide 3.0 mg | Occurrence of Anti-liraglutide Antibodies | Weeks 0 | 0 Participants |
| Liraglutide 3.0 mg | Occurrence of Anti-liraglutide Antibodies | Weeks 30 | 6 Participants |
| Liraglutide 3.0 mg | Occurrence of Anti-liraglutide Antibodies | Weeks 56 | 5 Participants |
| Liraglutide 3.0 mg | Occurrence of Anti-liraglutide Antibodies | Weeks 58 | 11 Participants |
| Liraglutide 3.0 mg | Occurrence of Anti-liraglutide Antibodies | Weeks 70 | 6 Participants |
Secondary
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time frame: Weeks 30, 56 and 82
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat \[ITT\] principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 30 (Yes) | 24.4 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 30 (No) | 75.6 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 56 (Yes) | 29.2 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 56 (No) | 70.8 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 82 (Yes) | 18.8 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 82 (No) | 81.3 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 82 (Yes) | 10.8 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 30 (Yes) | 5.2 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 56 (No) | 91.4 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 30 (No) | 94.8 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 82 (No) | 89.2 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥10% Reduction in Baseline BMI | Week 56 (Yes) | 8.6 Percentage of participants |
Secondary
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time frame: Weeks 30, 56 and 82
Population: Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat \[ITT\] principle). Overall Number of Participants Analyzed = FAS. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 82 (Yes) | 29.5 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 56 (No) | 54.9 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 30 (Yes) | 46.2 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 30 (No) | 53.8 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 82 (No) | 70.5 Percentage of participants |
| Liraglutide 3.0 mg | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 56 (Yes) | 45.1 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 82 (No) | 81.4 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 30 (No) | 85.3 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 56 (Yes) | 19.0 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 56 (No) | 81.0 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 82 (Yes) | 18.6 Percentage of participants |
| Placebo | Percent of Subjects Achieving ≥5% Reduction in Baseline BMI | Week 30 (Yes) | 14.7 Percentage of participants |