Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.
Interventions
DRUGsomapacitan
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
DRUGsomatropin
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.
DRUGplacebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent * Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included) * If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator * FOR ALL COUNTRIES EXCEPT JAPAN: Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test): 1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L) 2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m\^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m\^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m\^2, a peak GH less than 4 ng/mL (4 mcg/L) 3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria): a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)
Exclusion criteria
* Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin * Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Truncal Fat Percentage (Week 34) | Week -3, week 34 | Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Truncal Fat Mass (Week 34) | Week -3, week 34 | Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Truncal Fat Mass (Week 87) | week -3, week 87 | Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Truncal Lean Body Mass (Week 34) | Week -3, week 34 | Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Truncal Lean Body Mass (Week 87) | week -3, week 87 | Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Total Fat Mass (Week 34) | Week -3, week 34 | Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Total Fat Mass (Week 87) | Week -3, week 87 | Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Visceral Adipose Tissue (Week 34) | Week -3, week 34 | Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Visceral Adipose Tissue (Week 87) | Week -3, week 87 | Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Android Fat Mass (Week 34) | Week -3, week 34 | Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Android Fat Mass (Week 87) | week -3, week 87 | Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Gynoid Fat Mass (Week 34) | Week -3, week 34 | Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Gynoid Fat Mass (Week 87) | week -3, week 87 | Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Appendicular Skeletal Muscle Mass (Week 34) | Week -3, week 34 | Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Appendicular Skeletal Muscle Mass (Week 87) | week -3, week 87 | Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Lean Body Mass (Week 34) | Week -3, week 34 | Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Lean Body Mass (Week 87) | week -3, week 87 | Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Bone Mineral Content (Week 87) | week -3, week 87 | Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Bone Mineral Density (Week 87) | week -3, week 87 | Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in IGF-I SDS (Week 34) | Week -3, week 34 | Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome. |
| Change in IGF-I SDS (Week 87) | Week -3, week 87 | Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome. |
| Change in IGFBP 3 SDS (Week 34) | Week -3, week 34 | Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in IGFBP 3 SDS (Week 87) | Week -3, week 87 | Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Week 0, week 34 | Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome. |
| Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | week 0, week 87 | Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome. |
| Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Week 0, week 34 | SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. |
| Change in SF-36v2 (Summary and Domain Scores) (Week 87) | week 0, week 87 | SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. |
| TSQM-9 Scores (Domain Scores) (Week 34) | Week 34 | Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100. |
| TSQM-9 Scores (Domain Scores) (Week 87) | Week 87 | Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100. |
| Change in Total Cholesterol (Week 34) | Week -3, week 34 | Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Total Cholesterol (Week 87) | week -3, week 87 | Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in HDL-cholesterol (Week 34) | Week -3, week 34 | Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in HDL-cholesterol (Week 87) | week -3, week 87 | Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in LDL-cholesterol (Week 34) | Week -3, week 34 | Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in LDL-cholesterol (Week 87) | week -3, week 87 | Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Triglycerides (Week 34) | Week -3, week 34 | Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Triglycerides (Week 87) | week -3, week 87 | Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Hs-CRP (Week 34) | Week -3, week 34 | Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Hs-CRP (Week 87) | week -3, week 87 | Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in IL-6 (Week 34) | Week -3, week 34 | Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in IL-6 (Week 87) | week -3, week 87 | Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Body Weight (Week 34) | Week -3, week 34 | Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Body Weight (Week 87) | week -3, week 87 | Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Waist Circumference (Week 34) | Week -3, week 34 | Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Waist Circumference (Week 87) | week -3, week 87 | Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Number of Adverse Events (Weeks 0-35) | Weeks 0-35 | Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions. |
| Number of Adverse Events (Weeks 0-88) | Weeks 0-88 | Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions. |
| Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) | Weeks 0 to 35 | Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies. |
| Change in Alkaline Phosphatase (ALP) (Week 34) | Week -3, week 34 | Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | Weeks 0 to 88 | Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies. |
| Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) | Weeks 0 to 35 | Incidence of technical complaints were recorded from baseline (week 0) until week 35. |
| Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) | Weeks 0 to 88 | Incidence of technical complaints were recorded from baseline (week 0) until week 88. |
| Change in Physical Examination During Exposure to Trial Product (Week 35) | Week 0 and week 35 | Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation |
| Change in Physical Examination During Exposure to Trial Product (Week 88) | Week 0 and week 88 | Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation |
| Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 and week 35 | Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported. |
| Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 and week 88 | Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported. |
| Change in Diastolic Blood Pressure (Week 35) | Week -3, week 35 | Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35). |
| Change in Diastolic Blood Pressure (Week 88) | Week -3, week 88 | Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88. |
| Change in Systolic Blood Pressure (Week 35) | Week -3, week 35 | Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35). |
| Change in Systolic Blood Pressure (Week 88) | Week -3, week 88 | Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88). |
| Change in Pulse (Week 35) | Week -3, week 35 | Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35). |
| Change in Pulse (Week 88) | Week -3, week 88 | Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88). |
| Change in Haemoglobin (Week 34) | Week -3, week 34 | Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Haemoglobin (Week 87) | week -3, week 87 | Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87. |
| Change in Haematocrit (Week 34) | Week -3, week 34 | Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Haematocrit (Week 87) | week -3, week 87 | Change in Haematocrit was measured from baseline (week -3) until the end of the week 87. |
| Change in Erythrocytes (Week 34) | Week -3, week 34 | Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Erythrocytes (Week 87) | week -3, week 87 | Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87. |
| Change in Mean Corpuscular Volume (MCV) (Week 34) | Week -3, week 34 | Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Mean Corpuscular Volume (MCV) (Week 87) | week -3, week 87 | Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87. |
| Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) | Week -3, week 34 | Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) | week -3, week 87 | Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87. |
| Change in Thrombocytes (Week 34) | Week -3, week 34 | Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Thrombocytes (Week 87) | week -3, week 87 | Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87. |
| Change in Leucocytes (Week 34) | Week -3, week 34 | Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Leucocytes (Week 87) | week -3, week 87 | Change in Leucocytes was measured from baseline (week -3) until the end of the week 87. |
| Change in Alanine Aminotransferase (ALT) (Week 34) | Week -3, week 34 | Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Alanine Aminotransferase (ALT) (Week 87) | week -3, week 87 | Change in ALT was measured from baseline (week -3) until the end of the week 87. |
| Change in Albumin (Week 34) | Week -3, week 34 | Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Albumin (Week 87) | week -3, week 87 | Change in Albumin was measured from baseline (week -3) until the end of the week 87. |
| Change in Alkaline Phosphatase (AP) (Week 87) | Week -3, week 87 | Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87. |
| Change in Aspartate Aminotransferase (AST) (Week 34) | Week -3, week 34 | Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Aspartate Aminotransferase (AST) (Week 87) | Week -3, week 87 | Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Bilirubin (Week 34) | Week -3, week 34 | Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Bilirubin (Week 87) | week -3, week 87 | Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Calcium (Week 34) | Week -3, week 34 | Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Calcium (Week 87) | week -3, week 87 | Change in Calcium was measured from baseline (week -3) until the end of the week 87. |
| Change in Chloride (Week 34) | Week -3, week 34 | Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Chloride (Week 87) | week -3, week 87 | Change in Chloride was measured from baseline (week -3) until the end of the week 87. |
| Change in Creatinine (Week 34) | Week -3, week 34 | Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Creatinine (Week 87) | week -3, week 87 | Change in Creatinine was measured from baseline (week -3) until the end of the week 87. |
| Change in Creatine Kinase (Week 34) | Week -3, week 34 | Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Creatine Kinase (Week 87) | week -3, week 87 | Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87. |
| Change in Gamma-glutamyl Transferase (GGT) (Week 34) | Week -3, week 34 | Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Gamma-glutamyl Transferase (GGT) (Week 87) | week -3, week 87 | Change in GGT was measured from baseline (week -3) until the end of the week 87. |
| Change in Phosphate (Inorganic) (Week 34) | Week -3, week 34 | Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Phosphate (Inorganic)(Week 87) | week -3, week 87 | Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87. |
| Change in Potassium (Week 34) | Week -3, week 34 | Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Potassium (Week 87) | week -3, week 87 | Change in Potassium was measured from baseline (week -3) until the end of the week 87. |
| Change in Sodium (Week 34) | Week -3, week 34 | Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Sodium (Week 87) | week -3, week 87 | Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Total Protein (Week 34) | Week -3, week 34 | Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Total Protein (Week 87) | week -3, week 87 | Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87). |
| Change in Urea (Week 34) | Week -3, week 34 | Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Truncal Fat Percentage (Week 87) | week -3, week 87 | Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Uric Acid (Week 34) | Week -3, week 34 | Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Uric Acid (Week 87) | week -3, week 87 | Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) | Week -3, week 34 | Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) | week -3, week 87 | Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Fasting Plasma Glucose (Week 34) | Week -3, week 34 | Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Fasting Plasma Glucose (Week 87) | week -3, week 87 | Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Fasting Insulin (Week 34) | Week -3, week 34 | Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Fasting Insulin (Week 87) | week -3, week 87 | Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Steady State Beta Cell Function (%B) (Week 34) | Week -3, week 34 | Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Steady State Beta Cell Function (%B) (Week 87) | week -3, week 87 | Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87. |
| Change in Insulin Resistance (IR %) (Week 34) | Week -3, week 34 | Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Insulin Resistance (IR %) (Week 87) | week -3, week 87 | Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) | Week -3, week 34 | Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34). |
| Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) | week -3, week 87 | Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
| Change in Urea (Week 87) | week -3, week 87 | Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87). |
Countries
Australia, Brazil, Germany, India, Israel, Japan, Latvia, Lithuania, Malaysia, Norway, Poland, Romania, Russia, South Africa, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 92 sites in 16 countries: Australia - 8, Germany - 4, India - 5, Japan - 14, Latvia - 1, Lithuania - 2, Malaysia - 3, Poland - 5, Romania - 5, Russian Fed. - 6, South Africa - 3, Sweden - 1, Turkey - 4, Ukraine - 1, United Kingdom - 4, United States - 26.
Pre-assignment details
The trial had a main phase and an extension phase. Participants were treated for 34 weeks in the main phase (followed by 1 week washout) and for 52 weeks in the extension phase (followed by 1 week washout).300 participants received treatment;1 participant was randomised but didn't receive any treatment and was therefore not included in any analyses
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | 61 |
| Norditropin Participants received Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial.
Participants were re-randomised to receive somapacitan while other continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension part of the trial. | 119 |
| Somapacitan Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. Participants continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | 120 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Extension Phase (Open-label Phase) | Death | 0 | 0 | 0 | 1 | 0 | 1 | 1 |
| Extension Phase (Open-label Phase) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Extension Phase (Open-label Phase) | Withdrawal by Subject | 0 | 0 | 0 | 1 | 4 | 3 | 1 |
| Main Phase (Double-blind Phase) | Death | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Main Phase (Double-blind Phase) | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Main Phase (Double-blind Phase) | Protocol Violation | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Main Phase (Double-blind Phase) | Unclassified | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Main Phase (Double-blind Phase) | Withdrawal by Subject | 4 | 12 | 4 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Somapacitan | Norditropin |
|---|---|---|---|---|
| Age, Continuous | 45.0 Years STANDARD_DEVIATION 15.7 | 45.1 Years STANDARD_DEVIATION 15 | 44.6 Years STANDARD_DEVIATION 14.3 | 45.7 Years STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized Asian | 16 Participants | 86 Participants | 34 Participants | 36 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 7 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 18 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not applicable | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 57 Participants | 280 Participants | 114 Participants | 109 Participants |
| Race/Ethnicity, Customized Other: Caucasian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other: Hispanic | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other: Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 200 Participants | 82 Participants | 76 Participants |
| Sex: Female, Male Female | 32 Participants | 155 Participants | 62 Participants | 61 Participants |
| Sex: Female, Male Male | 29 Participants | 145 Participants | 58 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 61 | 0 / 120 | 1 / 119 | 2 / 220 | 1 / 52 |
| other Total, other adverse events | 29 / 61 | 53 / 120 | 55 / 119 | 85 / 220 | 27 / 52 |
| serious Total, serious adverse events | 5 / 61 | 7 / 120 | 12 / 119 | 15 / 220 | 3 / 52 |
Outcome results
Primary
Change in Truncal Fat Percentage (Week 34)
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Truncal Fat Percentage (Week 34) | 0.49 Percentage of truncal fat | Standard Deviation 3.31 |
| Norditropin | Change in Truncal Fat Percentage (Week 34) | -2.39 Percentage of truncal fat | Standard Deviation 4.48 |
| Somapacitan | Change in Truncal Fat Percentage (Week 34) | -1.17 Percentage of truncal fat | Standard Deviation 2.89 |
Comparison: Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.p-value: =0.00995% CI: [-2.68, -0.38]ANCOVA
Secondary
Change in Alanine Aminotransferase (ALT) (Week 34)
Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Alanine Aminotransferase (ALT) (Week 34) | 4.5 U/L | Standard Deviation 24.7 |
| Norditropin | Change in Alanine Aminotransferase (ALT) (Week 34) | -1.4 U/L | Standard Deviation 11.9 |
| Somapacitan | Change in Alanine Aminotransferase (ALT) (Week 34) | -4.4 U/L | Standard Deviation 17.9 |
Secondary
Change in Alanine Aminotransferase (ALT) (Week 87)
Change in ALT was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Alanine Aminotransferase (ALT) (Week 87) | -1.1 U/L | Standard Deviation 13.1 |
| Norditropin | Change in Alanine Aminotransferase (ALT) (Week 87) | -4.3 U/L | Standard Deviation 16.9 |
| Somapacitan | Change in Alanine Aminotransferase (ALT) (Week 87) | 0.6 U/L | Standard Deviation 12.5 |
| Norditropin/Somapacitan | Change in Alanine Aminotransferase (ALT) (Week 87) | -3.0 U/L | Standard Deviation 14.6 |
Secondary
Change in Albumin (Week 34)
Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Albumin (Week 34) | 6.09 g/L | Standard Deviation 3.56 |
| Norditropin | Change in Albumin (Week 34) | -0.72 g/L | Standard Deviation 2.81 |
| Somapacitan | Change in Albumin (Week 34) | -0.42 g/L | Standard Deviation 3.06 |
Secondary
Change in Albumin (Week 87)
Change in Albumin was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Albumin (Week 87) | -1.19 g/L | Standard Deviation 3.15 |
| Norditropin | Change in Albumin (Week 87) | -0.86 g/L | Standard Deviation 3.12 |
| Somapacitan | Change in Albumin (Week 87) | -1.12 g/L | Standard Deviation 3.52 |
| Norditropin/Somapacitan | Change in Albumin (Week 87) | -1.69 g/L | Standard Deviation 3.01 |
Secondary
Change in Alkaline Phosphatase (ALP) (Week 34)
Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Alkaline Phosphatase (ALP) (Week 34) | 1.8 U/L | Standard Deviation 16.5 |
| Norditropin | Change in Alkaline Phosphatase (ALP) (Week 34) | 7.9 U/L | Standard Deviation 24.3 |
| Somapacitan | Change in Alkaline Phosphatase (ALP) (Week 34) | 5.8 U/L | Standard Deviation 14.9 |
Secondary
Change in Alkaline Phosphatase (AP) (Week 87)
Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.
Time frame: Week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Alkaline Phosphatase (AP) (Week 87) | 8.1 U/L | Standard Deviation 20.2 |
| Norditropin | Change in Alkaline Phosphatase (AP) (Week 87) | 5.4 U/L | Standard Deviation 16 |
| Somapacitan | Change in Alkaline Phosphatase (AP) (Week 87) | 3.3 U/L | Standard Deviation 22.2 |
| Norditropin/Somapacitan | Change in Alkaline Phosphatase (AP) (Week 87) | 4.2 U/L | Standard Deviation 18 |
Secondary
Change in Android Fat Mass (Week 34)
Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Android Fat Mass (Week 34) | 56.32 gram | Standard Deviation 293.93 |
| Norditropin | Change in Android Fat Mass (Week 34) | -158.98 gram | Standard Deviation 325.35 |
| Somapacitan | Change in Android Fat Mass (Week 34) | -81.52 gram | Standard Deviation 361.62 |
Secondary
Change in Android Fat Mass (Week 87)
Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Android Fat Mass (Week 87) | -107.16 gram | Standard Deviation 367.14 |
| Norditropin | Change in Android Fat Mass (Week 87) | -39.76 gram | Standard Deviation 481.66 |
| Somapacitan | Change in Android Fat Mass (Week 87) | -100.76 gram | Standard Deviation 386.24 |
| Norditropin/Somapacitan | Change in Android Fat Mass (Week 87) | 11.52 gram | Standard Deviation 489.85 |
Secondary
Change in Appendicular Skeletal Muscle Mass (Week 34)
Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Appendicular Skeletal Muscle Mass (Week 34) | -76.22 gram | Standard Deviation 1006.58 |
| Norditropin | Change in Appendicular Skeletal Muscle Mass (Week 34) | 482.76 gram | Standard Deviation 1246.89 |
| Somapacitan | Change in Appendicular Skeletal Muscle Mass (Week 34) | 565.21 gram | Standard Deviation 1011.18 |
Secondary
Change in Appendicular Skeletal Muscle Mass (Week 87)
Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Appendicular Skeletal Muscle Mass (Week 87) | 447.96 gram | Standard Deviation 1688.08 |
| Norditropin | Change in Appendicular Skeletal Muscle Mass (Week 87) | 538.45 gram | Standard Deviation 1224.13 |
| Somapacitan | Change in Appendicular Skeletal Muscle Mass (Week 87) | 464.75 gram | Standard Deviation 1513.96 |
| Norditropin/Somapacitan | Change in Appendicular Skeletal Muscle Mass (Week 87) | 632.18 gram | Standard Deviation 1928.68 |
Secondary
Change in Aspartate Aminotransferase (AST) (Week 34)
Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Aspartate Aminotransferase (AST) (Week 34) | 1.96 U/L | Standard Deviation 15.11 |
| Norditropin | Change in Aspartate Aminotransferase (AST) (Week 34) | -0.80 U/L | Standard Deviation 9.38 |
| Somapacitan | Change in Aspartate Aminotransferase (AST) (Week 34) | -2.00 U/L | Standard Deviation 13.97 |
Secondary
Change in Aspartate Aminotransferase (AST) (Week 87)
Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: Week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Aspartate Aminotransferase (AST) (Week 87) | 1.76 U/L | Standard Deviation 24.346 |
| Norditropin | Change in Aspartate Aminotransferase (AST) (Week 87) | -2.17 U/L | Standard Deviation 13.98 |
| Somapacitan | Change in Aspartate Aminotransferase (AST) (Week 87) | -0.43 U/L | Standard Deviation 5.94 |
| Norditropin/Somapacitan | Change in Aspartate Aminotransferase (AST) (Week 87) | -1.69 U/L | Standard Deviation 12.75 |
Secondary
Change in Bilirubin (Week 34)
Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Bilirubin (Week 34) | -0.08 umol/L | Standard Deviation 4.76 |
| Norditropin | Change in Bilirubin (Week 34) | -0.38 umol/L | Standard Deviation 4.1 |
| Somapacitan | Change in Bilirubin (Week 34) | -0.41 umol/L | Standard Deviation 4.09 |
Secondary
Change in Bilirubin (Week 87)
Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Bilirubin (Week 87) | 0.04 umol/L | Standard Deviation 3.77 |
| Norditropin | Change in Bilirubin (Week 87) | 0.14 umol/L | Standard Deviation 4.45 |
| Somapacitan | Change in Bilirubin (Week 87) | 0.45 umol/L | Standard Deviation 3.24 |
| Norditropin/Somapacitan | Change in Bilirubin (Week 87) | -0.33 umol/L | Standard Deviation 4.52 |
Secondary
Change in Body Weight (Week 34)
Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Body Weight (Week 34) | 0.6 Kg | Standard Deviation 2.9 |
| Norditropin | Change in Body Weight (Week 34) | 0.2 Kg | Standard Deviation 4 |
| Somapacitan | Change in Body Weight (Week 34) | 1.3 Kg | Standard Deviation 4.2 |
Secondary
Change in Body Weight (Week 87)
Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Body Weight (Week 87) | 1.2 Kg | Standard Deviation 4.4 |
| Norditropin | Change in Body Weight (Week 87) | 1.4 Kg | Standard Deviation 4.8 |
| Somapacitan | Change in Body Weight (Week 87) | 0.4 Kg | Standard Deviation 5.2 |
| Norditropin/Somapacitan | Change in Body Weight (Week 87) | 2.1 Kg | Standard Deviation 7 |
Secondary
Change in Bone Mineral Content (Week 87)
Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Bone Mineral Content (Week 87) | -25.61 gram | Standard Deviation 93.35 |
| Norditropin | Change in Bone Mineral Content (Week 87) | 5.02 gram | Standard Deviation 113.81 |
| Somapacitan | Change in Bone Mineral Content (Week 87) | -10.18 gram | Standard Deviation 99.18 |
| Norditropin/Somapacitan | Change in Bone Mineral Content (Week 87) | 32.33 gram | Standard Deviation 87.86 |
Secondary
Change in Bone Mineral Density (Week 87)
Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Bone Mineral Density (Week 87) | -0.01 grams per square centimeter | Standard Deviation 0.04 |
| Norditropin | Change in Bone Mineral Density (Week 87) | -0.00 grams per square centimeter | Standard Deviation 0.04 |
| Somapacitan | Change in Bone Mineral Density (Week 87) | -0.00 grams per square centimeter | Standard Deviation 0.04 |
| Norditropin/Somapacitan | Change in Bone Mineral Density (Week 87) | 0.01 grams per square centimeter | Standard Deviation 0.04 |
Secondary
Change in Calcium (Week 34)
Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Calcium (Week 34) | 0.00 mmol/L | Standard Deviation 0.13 |
| Norditropin | Change in Calcium (Week 34) | 0.04 mmol/L | Standard Deviation 0.14 |
| Somapacitan | Change in Calcium (Week 34) | 0.03 mmol/L | Standard Deviation 0.11 |
Secondary
Change in Calcium (Week 87)
Change in Calcium was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Calcium (Week 87) | 0.01 mmol/L | Standard Deviation 0.12 |
| Norditropin | Change in Calcium (Week 87) | 0.03 mmol/L | Standard Deviation 0.12 |
| Somapacitan | Change in Calcium (Week 87) | 0.03 mmol/L | Standard Deviation 0.11 |
| Norditropin/Somapacitan | Change in Calcium (Week 87) | 0.01 mmol/L | Standard Deviation 0.12 |
Secondary
Change in Chloride (Week 34)
Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Chloride (Week 34) | -1.1 mmol/L | Standard Deviation 2.7 |
| Norditropin | Change in Chloride (Week 34) | -0.6 mmol/L | Standard Deviation 2.9 |
| Somapacitan | Change in Chloride (Week 34) | -0.3 mmol/L | Standard Deviation 2.9 |
Secondary
Change in Chloride (Week 87)
Change in Chloride was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Chloride (Week 87) | -1.8 mmol/L | Standard Deviation 3.5 |
| Norditropin | Change in Chloride (Week 87) | -1.0 mmol/L | Standard Deviation 3 |
| Somapacitan | Change in Chloride (Week 87) | -1.1 mmol/L | Standard Deviation 3.2 |
| Norditropin/Somapacitan | Change in Chloride (Week 87) | -0.6 mmol/L | Standard Deviation 3.1 |
Secondary
Change in Creatine Kinase (Week 34)
Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Creatine Kinase (Week 34) | 5.0 U/L | Standard Deviation 136.6 |
| Norditropin | Change in Creatine Kinase (Week 34) | 10.9 U/L | Standard Deviation 101 |
| Somapacitan | Change in Creatine Kinase (Week 34) | -23.5 U/L | Standard Deviation 355 |
Secondary
Change in Creatine Kinase (Week 87)
Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Creatine Kinase (Week 87) | 228.7 U/L | Standard Deviation 1603.3 |
| Norditropin | Change in Creatine Kinase (Week 87) | -9.4 U/L | Standard Deviation 411.3 |
| Somapacitan | Change in Creatine Kinase (Week 87) | 1.3 U/L | Standard Deviation 89.3 |
| Norditropin/Somapacitan | Change in Creatine Kinase (Week 87) | 30.5 U/L | Standard Deviation 125.7 |
Secondary
Change in Creatinine (Week 34)
Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Creatinine (Week 34) | 0.9 umol/L | Standard Deviation 9.4 |
| Norditropin | Change in Creatinine (Week 34) | -2.8 umol/L | Standard Deviation 10.9 |
| Somapacitan | Change in Creatinine (Week 34) | -2.9 umol/L | Standard Deviation 10.6 |
Secondary
Change in Creatinine (Week 87)
Change in Creatinine was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Creatinine (Week 87) | -5.6 umol/L | Standard Deviation 11.9 |
| Norditropin | Change in Creatinine (Week 87) | -2.5 umol/L | Standard Deviation 11.7 |
| Somapacitan | Change in Creatinine (Week 87) | -2.0 umol/L | Standard Deviation 9.8 |
| Norditropin/Somapacitan | Change in Creatinine (Week 87) | 1.8 umol/L | Standard Deviation 41.2 |
Secondary
Change in Diastolic Blood Pressure (Week 35)
Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time frame: Week -3, week 35
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Diastolic Blood Pressure (Week 35) | -0.41 mm Hg | Standard Deviation 7.75 |
| Norditropin | Change in Diastolic Blood Pressure (Week 35) | -2.07 mm Hg | Standard Deviation 8.73 |
| Somapacitan | Change in Diastolic Blood Pressure (Week 35) | -1.42 mm Hg | Standard Deviation 8.98 |
Secondary
Change in Diastolic Blood Pressure (Week 88)
Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.
Time frame: Week -3, week 88
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Diastolic Blood Pressure (Week 88) | -2.48 mm Hg | Standard Deviation 7.77 |
| Norditropin | Change in Diastolic Blood Pressure (Week 88) | -0.85 mm Hg | Standard Deviation 9.21 |
| Somapacitan | Change in Diastolic Blood Pressure (Week 88) | -0.61 mm Hg | Standard Deviation 8.71 |
| Norditropin/Somapacitan | Change in Diastolic Blood Pressure (Week 88) | -2.10 mm Hg | Standard Deviation 9.5 |
Secondary
Change in ECG Evaluation During Exposure to Trial Product (Week 88)
Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.
Time frame: Week -3 and week 88
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Normal | 34 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Missing | 0 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Missing | 1 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, CS | 2 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, CS | 1 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, NCS | 29 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, NCS | 18 Participants |
| Placebo | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Normal | 30 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, CS | 1 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, NCS | 40 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Missing | 0 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Normal | 77 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, CS | 3 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Missing | 0 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Normal | 74 Participants |
| Norditropin | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, NCS | 34 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Normal | 26 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Missing | 0 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Missing | 0 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, NCS | 26 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Normal | 29 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, CS | 2 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, NCS | 18 Participants |
| Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, NCS | 12 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Missing | 1 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, NCS | 17 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Normal | 34 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, CS | 1 Participants |
| Norditropin/Somapacitan | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Normal | 35 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Missing | 1 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Normal | 7 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, NCS | 9 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week -3 | Missing | 0 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Normal | 0 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Week 88 | Abnormal, CS | 0 Participants |
Secondary
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)
Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.
Time frame: Week -3 and week 35
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Normal | 30 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Abnormal, NCS | 29 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Abnormal, CS | 2 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Missing | 0 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Normal | 29 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Abnormal, NCS | 26 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Abnormal, CS | 1 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Missing | 1 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Abnormal, CS | 0 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Abnormal, CS | 0 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Missing | 0 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Normal | 65 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Abnormal, NCS | 42 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Normal | 67 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Abnormal, NCS | 52 Participants |
| Norditropin | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Missing | 4 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Abnormal, CS | 3 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Abnormal, NCS | 40 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Normal | 77 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week -3 | Missing | 0 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Abnormal, CS | 2 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Abnormal, NCS | 34 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Normal | 77 Participants |
| Somapacitan | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Week 35 | Missing | 6 Participants |
Secondary
Change in Erythrocytes (Week 34)
Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Erythrocytes (Week 34) | 0.09 cells/pL | Standard Deviation 0.33 |
| Norditropin | Change in Erythrocytes (Week 34) | 0.06 cells/pL | Standard Deviation 0.29 |
| Somapacitan | Change in Erythrocytes (Week 34) | 0.08 cells/pL | Standard Deviation 0.32 |
Secondary
Change in Erythrocytes (Week 87)
Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Erythrocytes (Week 87) | 0.09 cells/pL | Standard Deviation 0.34 |
| Norditropin | Change in Erythrocytes (Week 87) | 0.12 cells/pL | Standard Deviation 0.35 |
| Somapacitan | Change in Erythrocytes (Week 87) | 0.01 cells/pL | Standard Deviation 0.31 |
| Norditropin/Somapacitan | Change in Erythrocytes (Week 87) | 0.05 cells/pL | Standard Deviation 0.54 |
Secondary
Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) | 5.36 mL/min/1.73m^2 | Standard Deviation 12.67 |
| Norditropin | Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) | 2.38 mL/min/1.73m^2 | Standard Deviation 12.28 |
| Somapacitan | Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) | 1.44 mL/min/1.73m^2 | Standard Deviation 10.52 |
| Norditropin/Somapacitan | Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) | 1.67 mL/min/1.73m^2 | Standard Deviation 15.77 |
Secondary
Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)
Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) | -1.34 mL/min/1.73m^2 | Standard Deviation 10.68 |
| Norditropin | Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) | 2.77 mL/min/1.73m^2 | Standard Deviation 10.07 |
| Somapacitan | Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) | 2.57 mL/min/1.73m^2 | Standard Deviation 11.24 |
Secondary
Change in Fasting Insulin (Week 34)
Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Fasting Insulin (Week 34) | 14.563 pmol/L | Standard Deviation 45.217 |
| Norditropin | Change in Fasting Insulin (Week 34) | 27.580 pmol/L | Standard Deviation 76.23 |
| Somapacitan | Change in Fasting Insulin (Week 34) | 12.778 pmol/L | Standard Deviation 53.703 |
Secondary
Change in Fasting Insulin (Week 87)
Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Fasting Insulin (Week 87) | 12.2 pmol/L | Standard Deviation 57.31 |
| Norditropin | Change in Fasting Insulin (Week 87) | -3.7 pmol/L | Standard Deviation 62.39 |
| Somapacitan | Change in Fasting Insulin (Week 87) | -6.5 pmol/L | Standard Deviation 53.67 |
| Norditropin/Somapacitan | Change in Fasting Insulin (Week 87) | 13.4 pmol/L | Standard Deviation 54.4 |
Secondary
Change in Fasting Plasma Glucose (Week 34)
Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Fasting Plasma Glucose (Week 34) | 0.01 mmol/L | Standard Deviation 0.42 |
| Norditropin | Change in Fasting Plasma Glucose (Week 34) | 0.12 mmol/L | Standard Deviation 0.65 |
| Somapacitan | Change in Fasting Plasma Glucose (Week 34) | 0.00 mmol/L | Standard Deviation 0.56 |
Secondary
Change in Fasting Plasma Glucose (Week 87)
Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Fasting Plasma Glucose (Week 87) | 0.06 mmol/L | Standard Deviation 0.46 |
| Norditropin | Change in Fasting Plasma Glucose (Week 87) | 0.13 mmol/L | Standard Deviation 0.77 |
| Somapacitan | Change in Fasting Plasma Glucose (Week 87) | 0.05 mmol/L | Standard Deviation 0.68 |
| Norditropin/Somapacitan | Change in Fasting Plasma Glucose (Week 87) | 0.04 mmol/L | Standard Deviation 0.6 |
Secondary
Change in Gamma-glutamyl Transferase (GGT) (Week 34)
Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Gamma-glutamyl Transferase (GGT) (Week 34) | 9.3 U/L | Standard Deviation 66.2 |
| Norditropin | Change in Gamma-glutamyl Transferase (GGT) (Week 34) | -5.8 U/L | Standard Deviation 17 |
| Somapacitan | Change in Gamma-glutamyl Transferase (GGT) (Week 34) | -4.2 U/L | Standard Deviation 27.5 |
Secondary
Change in Gamma-glutamyl Transferase (GGT) (Week 87)
Change in GGT was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Gamma-glutamyl Transferase (GGT) (Week 87) | 19.4 U/L | Standard Deviation 16.4 |
| Norditropin | Change in Gamma-glutamyl Transferase (GGT) (Week 87) | 29.3 U/L | Standard Deviation 39.3 |
| Somapacitan | Change in Gamma-glutamyl Transferase (GGT) (Week 87) | 25.9 U/L | Standard Deviation 23.8 |
| Norditropin/Somapacitan | Change in Gamma-glutamyl Transferase (GGT) (Week 87) | 20.7 U/L | Standard Deviation 13.9 |
Secondary
Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) | 0.04 Percentage of HbA1c | Standard Deviation 0.37 |
| Norditropin | Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) | 0.09 Percentage of HbA1c | Standard Deviation 0.26 |
| Somapacitan | Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) | 0.09 Percentage of HbA1c | Standard Deviation 0.31 |
Secondary
Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)
Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) | 0.09 Percentage of HbA1c | Standard Deviation 0.26 |
| Norditropin | Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) | 0.11 Percentage of HbA1c | Standard Deviation 0.37 |
| Somapacitan | Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) | 0.10 Percentage of HbA1c | Standard Deviation 0.28 |
| Norditropin/Somapacitan | Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) | 0.07 Percentage of HbA1c | Standard Deviation 0.27 |
Secondary
Change in Gynoid Fat Mass (Week 34)
Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Gynoid Fat Mass (Week 34) | 8.35 gram | Standard Deviation 567.04 |
| Norditropin | Change in Gynoid Fat Mass (Week 34) | -128.59 gram | Standard Deviation 471 |
| Somapacitan | Change in Gynoid Fat Mass (Week 34) | 22.66 gram | Standard Deviation 510.45 |
Secondary
Change in Gynoid Fat Mass (Week 87)
Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Gynoid Fat Mass (Week 87) | -92.00 gram | Standard Deviation 759.37 |
| Norditropin | Change in Gynoid Fat Mass (Week 87) | 10.23 gram | Standard Deviation 557.2 |
| Somapacitan | Change in Gynoid Fat Mass (Week 87) | -100.97 gram | Standard Deviation 620.16 |
| Norditropin/Somapacitan | Change in Gynoid Fat Mass (Week 87) | 140.02 gram | Standard Deviation 790.74 |
Secondary
Change in Haematocrit (Week 34)
Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Haematocrit (Week 34) | 0.5 % of red blood cells | Standard Deviation 3.3 |
| Norditropin | Change in Haematocrit (Week 34) | -0.3 % of red blood cells | Standard Deviation 2.9 |
| Somapacitan | Change in Haematocrit (Week 34) | 0.1 % of red blood cells | Standard Deviation 3.1 |
Secondary
Change in Haematocrit (Week 87)
Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Haematocrit (Week 87) | 0.17 % of red blood cells | Standard Deviation 3.44 |
| Norditropin | Change in Haematocrit (Week 87) | 0.21 % of red blood cells | Standard Deviation 3.29 |
| Somapacitan | Change in Haematocrit (Week 87) | -0.59 % of red blood cells | Standard Deviation 2.78 |
| Norditropin/Somapacitan | Change in Haematocrit (Week 87) | -0.48 % of red blood cells | Standard Deviation 5.1 |
Secondary
Change in Haemoglobin (Week 34)
Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Haemoglobin (Week 34) | 1.87 g/L | Standard Deviation 10.25 |
| Norditropin | Change in Haemoglobin (Week 34) | -0.51 g/L | Standard Deviation 8.8 |
| Somapacitan | Change in Haemoglobin (Week 34) | 0.64 g/L | Standard Deviation 8.78 |
Secondary
Change in Haemoglobin (Week 87)
Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Haemoglobin (Week 87) | 2.93 g/L | Standard Deviation 11.36 |
| Norditropin | Change in Haemoglobin (Week 87) | 2.76 g/L | Standard Deviation 9.54 |
| Somapacitan | Change in Haemoglobin (Week 87) | -0.40 g/L | Standard Deviation 9.22 |
| Norditropin/Somapacitan | Change in Haemoglobin (Week 87) | 0.86 g/L | Standard Deviation 15.96 |
Secondary
Change in HDL-cholesterol (Week 34)
Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in HDL-cholesterol (Week 34) | -0.00 mmol/L | Standard Deviation 0.37 |
| Norditropin | Change in HDL-cholesterol (Week 34) | 0.02 mmol/L | Standard Deviation 0.28 |
| Somapacitan | Change in HDL-cholesterol (Week 34) | 0.05 mmol/L | Standard Deviation 0.3 |
Secondary
Change in HDL-cholesterol (Week 87)
Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in HDL-cholesterol (Week 87) | 0.06 mmol/L | Standard Deviation 0.3 |
| Norditropin | Change in HDL-cholesterol (Week 87) | 0.05 mmol/L | Standard Deviation 0.32 |
| Somapacitan | Change in HDL-cholesterol (Week 87) | 0.09 mmol/L | Standard Deviation 0.27 |
| Norditropin/Somapacitan | Change in HDL-cholesterol (Week 87) | 0.06 mmol/L | Standard Deviation 0.34 |
Secondary
Change in Hs-CRP (Week 34)
Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hs-CRP (Week 34) | 0.405 mg/L | Standard Deviation 13.144 |
| Norditropin | Change in Hs-CRP (Week 34) | -1.604 mg/L | Standard Deviation 13.254 |
| Somapacitan | Change in Hs-CRP (Week 34) | -0.569 mg/L | Standard Deviation 5.616 |
Secondary
Change in Hs-CRP (Week 87)
Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Hs-CRP (Week 87) | -0.325 mg/L | Standard Deviation 16.247 |
| Norditropin | Change in Hs-CRP (Week 87) | -1.445 mg/L | Standard Deviation 3.791 |
| Somapacitan | Change in Hs-CRP (Week 87) | -0.857 mg/L | Standard Deviation 17.491 |
| Norditropin/Somapacitan | Change in Hs-CRP (Week 87) | -1.257 mg/L | Standard Deviation 12.497 |
Secondary
Change in IGFBP 3 SDS (Week 34)
Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in IGFBP 3 SDS (Week 34) | 0.12 Standard deviation score | Standard Deviation 0.61 |
| Norditropin | Change in IGFBP 3 SDS (Week 34) | 1.44 Standard deviation score | Standard Deviation 1.17 |
| Somapacitan | Change in IGFBP 3 SDS (Week 34) | 1.56 Standard deviation score | Standard Deviation 1.24 |
Secondary
Change in IGFBP 3 SDS (Week 87)
Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: Week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in IGFBP 3 SDS (Week 87) | 1.33 Standard deviation score | Standard Deviation 1.2 |
| Norditropin | Change in IGFBP 3 SDS (Week 87) | 1.41 Standard deviation score | Standard Deviation 1.2 |
| Somapacitan | Change in IGFBP 3 SDS (Week 87) | 1.30 Standard deviation score | Standard Deviation 1.08 |
| Norditropin/Somapacitan | Change in IGFBP 3 SDS (Week 87) | 1.47 Standard deviation score | Standard Deviation 1.51 |
Secondary
Change in IGF-I SDS (Week 34)
Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in IGF-I SDS (Week 34) | 0.05 Standard deviation score | Standard Deviation 0.59 |
| Norditropin | Change in IGF-I SDS (Week 34) | 2.28 Standard deviation score | Standard Deviation 1.32 |
| Somapacitan | Change in IGF-I SDS (Week 34) | 2.37 Standard deviation score | Standard Deviation 1.33 |
Secondary
Change in IGF-I SDS (Week 87)
Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.
Time frame: Week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in IGF-I SDS (Week 87) | 2.36 Standard deviation score | Standard Deviation 1.55 |
| Norditropin | Change in IGF-I SDS (Week 87) | 2.29 Standard deviation score | Standard Deviation 1.39 |
| Somapacitan | Change in IGF-I SDS (Week 87) | 2.07 Standard deviation score | Standard Deviation 1.12 |
| Norditropin/Somapacitan | Change in IGF-I SDS (Week 87) | 2.35 Standard deviation score | Standard Deviation 1.54 |
Secondary
Change in IL-6 (Week 34)
Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in IL-6 (Week 34) | 3.48 pg/mL | Standard Deviation 24.84 |
| Norditropin | Change in IL-6 (Week 34) | 0.07 pg/mL | Standard Deviation 4.01 |
| Somapacitan | Change in IL-6 (Week 34) | 0.18 pg/mL | Standard Deviation 5.78 |
Secondary
Change in IL-6 (Week 87)
Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in IL-6 (Week 87) | 0.11 pg/mL | Standard Deviation 3.3 |
| Norditropin | Change in IL-6 (Week 87) | 0.52 pg/mL | Standard Deviation 6.19 |
| Somapacitan | Change in IL-6 (Week 87) | 0.49 pg/mL | Standard Deviation 5.12 |
| Norditropin/Somapacitan | Change in IL-6 (Week 87) | 1.19 pg/mL | Standard Deviation 2.92 |
Secondary
Change in Insulin Resistance (IR %) (Week 34)
Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Insulin Resistance (IR %) (Week 34) | 0.53 Percentage of insulin resistance | Standard Deviation 1.76 |
| Norditropin | Change in Insulin Resistance (IR %) (Week 34) | 1.26 Percentage of insulin resistance | Standard Deviation 3.42 |
| Somapacitan | Change in Insulin Resistance (IR %) (Week 34) | 0.47 Percentage of insulin resistance | Standard Deviation 2.32 |
Secondary
Change in Insulin Resistance (IR %) (Week 87)
Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Insulin Resistance (IR %) (Week 87) | 0.50 Percentage of insulin resistance | Standard Deviation 2.17 |
| Norditropin | Change in Insulin Resistance (IR %) (Week 87) | -0.06 Percentage of insulin resistance | Standard Deviation 3.14 |
| Somapacitan | Change in Insulin Resistance (IR %) (Week 87) | -0.02 Percentage of insulin resistance | Standard Deviation 1.99 |
| Norditropin/Somapacitan | Change in Insulin Resistance (IR %) (Week 87) | 0.52 Percentage of insulin resistance | Standard Deviation 2.26 |
Secondary
Change in LDL-cholesterol (Week 34)
Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in LDL-cholesterol (Week 34) | 0.02 mmol/L | Standard Deviation 0.75 |
| Norditropin | Change in LDL-cholesterol (Week 34) | -0.18 mmol/L | Standard Deviation 0.72 |
| Somapacitan | Change in LDL-cholesterol (Week 34) | -0.13 mmol/L | Standard Deviation 0.64 |
Secondary
Change in LDL-cholesterol (Week 87)
Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in LDL-cholesterol (Week 87) | -0.30 mmol/L | Standard Deviation 0.72 |
| Norditropin | Change in LDL-cholesterol (Week 87) | -0.06 mmol/L | Standard Deviation 0.81 |
| Somapacitan | Change in LDL-cholesterol (Week 87) | -0.15 mmol/L | Standard Deviation 0.85 |
| Norditropin/Somapacitan | Change in LDL-cholesterol (Week 87) | -0.36 mmol/L | Standard Deviation 0.9 |
Secondary
Change in Lean Body Mass (Week 34)
Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Lean Body Mass (Week 34) | 334.43 gram | Standard Deviation 2048.01 |
| Norditropin | Change in Lean Body Mass (Week 34) | 1359.33 gram | Standard Deviation 2359.11 |
| Somapacitan | Change in Lean Body Mass (Week 34) | 1395.88 gram | Standard Deviation 2139.32 |
Secondary
Change in Lean Body Mass (Week 87)
Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Lean Body Mass (Week 87) | 1717.15 gram | Standard Deviation 2965.23 |
| Norditropin | Change in Lean Body Mass (Week 87) | 1719.87 gram | Standard Deviation 2515.9 |
| Somapacitan | Change in Lean Body Mass (Week 87) | 1464.51 gram | Standard Deviation 2439.75 |
| Norditropin/Somapacitan | Change in Lean Body Mass (Week 87) | 1681.82 gram | Standard Deviation 3413.61 |
Secondary
Change in Leucocytes (Week 34)
Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Leucocytes (Week 34) | 0.22 10^9 cells/L | Standard Deviation 1.57 |
| Norditropin | Change in Leucocytes (Week 34) | -0.05 10^9 cells/L | Standard Deviation 1.5 |
| Somapacitan | Change in Leucocytes (Week 34) | -0.32 10^9 cells/L | Standard Deviation 1.75 |
Secondary
Change in Leucocytes (Week 87)
Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Leucocytes (Week 87) | 0.29 10^9 cells/L | Standard Deviation 1.93 |
| Norditropin | Change in Leucocytes (Week 87) | -0.12 10^9 cells/L | Standard Deviation 1.94 |
| Somapacitan | Change in Leucocytes (Week 87) | -0.14 10^9 cells/L | Standard Deviation 1.44 |
| Norditropin/Somapacitan | Change in Leucocytes (Week 87) | -0.14 10^9 cells/L | Standard Deviation 2.55 |
Secondary
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) | 0.1 mmol/L | Standard Deviation 0.5 |
| Norditropin | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) | 0.1 mmol/L | Standard Deviation 0.6 |
| Somapacitan | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) | 0.1 mmol/L | Standard Deviation 0.6 |
Secondary
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) | 0.36 mmol/L | Standard Deviation 0.47 |
| Norditropin | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) | 0.29 mmol/L | Standard Deviation 0.61 |
| Somapacitan | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) | 0.23 mmol/L | Standard Deviation 0.7 |
| Norditropin/Somapacitan | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) | 0.35 mmol/L | Standard Deviation 0.52 |
Secondary
Change in Mean Corpuscular Volume (MCV) (Week 34)
Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Mean Corpuscular Volume (MCV) (Week 34) | -0.6 fL | Standard Deviation 3.3 |
| Norditropin | Change in Mean Corpuscular Volume (MCV) (Week 34) | -1.8 fL | Standard Deviation 3.6 |
| Somapacitan | Change in Mean Corpuscular Volume (MCV) (Week 34) | -1.5 fL | Standard Deviation 3 |
Secondary
Change in Mean Corpuscular Volume (MCV) (Week 87)
Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Mean Corpuscular Volume (MCV) (Week 87) | -1.39 fL | Standard Deviation 4.27 |
| Norditropin | Change in Mean Corpuscular Volume (MCV) (Week 87) | -1.80 fL | Standard Deviation 3.31 |
| Somapacitan | Change in Mean Corpuscular Volume (MCV) (Week 87) | -1.31 fL | Standard Deviation 3.63 |
| Norditropin/Somapacitan | Change in Mean Corpuscular Volume (MCV) (Week 87) | -1.77 fL | Standard Deviation 3.66 |
Secondary
Change in Phosphate (Inorganic) (Week 34)
Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Phosphate (Inorganic) (Week 34) | -0.038 mmol/L | Standard Deviation 0.183 |
| Norditropin | Change in Phosphate (Inorganic) (Week 34) | 0.155 mmol/L | Standard Deviation 0.182 |
| Somapacitan | Change in Phosphate (Inorganic) (Week 34) | 0.181 mmol/L | Standard Deviation 0.202 |
Secondary
Change in Phosphate (Inorganic)(Week 87)
Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Phosphate (Inorganic)(Week 87) | 0.100 mmol/L | Standard Deviation 0.19 |
| Norditropin | Change in Phosphate (Inorganic)(Week 87) | 0.125 mmol/L | Standard Deviation 0.193 |
| Somapacitan | Change in Phosphate (Inorganic)(Week 87) | 0.076 mmol/L | Standard Deviation 0.19 |
| Norditropin/Somapacitan | Change in Phosphate (Inorganic)(Week 87) | 0.115 mmol/L | Standard Deviation 0.219 |
Secondary
Change in Physical Examination During Exposure to Trial Product (Week 35)
Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Time frame: Week 0 and week 35
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Normal | 53 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Abnormal, not clinically significant (NCS) | 5 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Abnormal, not clinically significant (NCS) | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Abnormal, not clinically significant (NCS) | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Normal | 54 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Normal | 55 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Normal | 56 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Normal | 51 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Normal | 54 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Abnormal, not clinically significant (NCS) | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Normal | 59 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Normal | 59 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Abnormal, not clinically significant (NCS) | 3 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Abnormal, not clinically significant (NCS) | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Normal | 51 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Normal | 56 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Abnormal, not clinically significant (NCS) | 9 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Normal | 51 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Abnormal, not clinically significant (NCS) | 5 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Normal | 56 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Normal | 55 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Abnormal, not clinically significant (NCS) | 4 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Abnormal, clinically significant (CS) | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Normal | 61 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Abnormal, not clinically significant (NCS) | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Abnormal, not clinically significant (NCS) | 6 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Normal | 59 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Normal | 61 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Abnormal, not clinically significant (NCS) | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Abnormal, clinically significant (CS) | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Normal | 111 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Abnormal, not clinically significant (NCS) | 6 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Abnormal, clinically significant (CS) | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Normal | 98 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Abnormal, not clinically significant (NCS) | 4 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Abnormal, clinically significant (CS) | 3 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Normal | 118 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Abnormal, not clinically significant (NCS) | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Normal | 103 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Abnormal, not clinically significant (NCS) | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Normal | 112 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Abnormal, not clinically significant (NCS) | 7 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Normal | 99 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Normal | 113 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Normal | 96 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Normal | 119 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Normal | 105 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Abnormal, not clinically significant (NCS) | 6 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Abnormal, not clinically significant (NCS) | 6 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Normal | 98 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Abnormal, not clinically significant (NCS) | 7 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Normal | 111 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Abnormal, not clinically significant (NCS) | 6 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Abnormal, clinically significant (CS) | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Abnormal, not clinically significant (NCS) | 7 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Abnormal, clinically significant (CS) | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Normal | 113 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Abnormal, not clinically significant (NCS) | 5 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Abnormal, clinically significant (CS) | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Normal | 101 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Abnormal, not clinically significant (NCS) | 4 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Normal | 100 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Abnormal, not clinically significant (NCS) | 17 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Abnormal, clinically significant (CS) | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Normal | 88 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Abnormal, not clinically significant (NCS) | 15 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Abnormal, not clinically significant (NCS) | 6 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Abnormal, clinically significant (CS) | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Normal | 120 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Normal | 117 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Abnormal, not clinically significant (NCS) | 9 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Abnormal, not clinically significant (NCS) | 3 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Abnormal, not clinically significant (NCS) | 4 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Normal | 116 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Normal | 114 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Normal | 107 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Abnormal, not clinically significant (NCS) | 4 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Central & Peripheral nervous sys (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Abnormal, not clinically significant (NCS) | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 35) | Normal | 117 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Normal | 108 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Abnormal, not clinically significant (NCS) | 11 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Abnormal, not clinically significant (NCS) | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Normal | 118 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Normal | 116 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Normal | 119 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Abnormal, not clinically significant (NCS) | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Abnormal, not clinically significant (NCS) | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Abnormal, clinically significant (CS) | 5 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Respiratory sys. (Week 0) | Normal | 119 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Normal | 113 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 35) | Normal | 112 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Lymph node palpation (Week 35) | Abnormal, not clinically significant (NCS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Abnormal, not clinically significant (NCS) | 5 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Abnormal, not clinically significant (NCS) | 13 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Abnormal, clinically significant (CS) | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Normal | 102 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 35) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 0) | Normal | 109 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Normal | 111 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Abnormal, clinically significant (CS) | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Skin (Week 35) | Abnormal, clinically significant (CS) | 3 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Musculoskeletal sys. (Week 35) | Abnormal, not clinically significant (NCS) | 5 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Gastrointestinal sys. (Week 0) | Abnormal, clinically significant (CS) | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 35) | Head, neck, eyes, nose (Week 0) | Abnormal, not clinically significant (NCS) | 7 Participants |
Secondary
Change in Physical Examination During Exposure to Trial Product (Week 88)
Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Time frame: Week 0 and week 88
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, NCS | 4 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Normal | 49 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Normal | 59 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Normal | 59 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Normal | 52 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, NCS | 6 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, NCS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Normal | 61 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, NCS | 4 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, CS | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Normal | 48 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, NCS | 3 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, NCS | 6 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Normal | 49 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, NCS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Normal | 61 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, CS | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, NCS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, NCS | 9 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Normal | 51 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Normal | 54 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, NCS | 1 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Normal | 53 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Normal | 53 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Normal | 56 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, CS | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, NCS | 2 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Normal | 59 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Missing | 0 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Normal | 52 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Normal | 55 Participants |
| Placebo | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, NCS | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, NCS | 7 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, NCS | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Normal | 108 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Normal | 101 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Normal | 106 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Normal | 107 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Normal | 109 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, CS | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, NCS | 5 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Normal | 119 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Normal | 113 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, NCS | 11 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, NCS | 2 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Normal | 109 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Normal | 108 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Missing | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, CS | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, NCS | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, NCS | 3 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, NCS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, NCS | 4 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, NCS | 7 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Normal | 116 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Normal | 120 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, CS | 5 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Normal | 109 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, NCS | 3 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, CS | 5 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Normal | 101 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, NCS | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, NCS | 8 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, NCS | 7 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Normal | 117 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Normal | 96 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, CS | 1 Participants |
| Norditropin | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Normal | 119 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, CS | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Normal | 52 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Normal | 49 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Normal | 49 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, CS | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Normal | 48 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Normal | 49 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, NCS | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, CS | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Normal | 46 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, NCS | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, CS | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, NCS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, NCS | 3 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, NCS | 4 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Normal | 49 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, NCS | 3 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Normal | 47 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, NCS | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Normal | 48 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, NCS | 2 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Normal | 45 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, NCS | 3 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Normal | 51 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, NCS | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Normal | 49 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, NCS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, NCS | 3 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, CS | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Missing | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Normal | 42 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, NCS | 6 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, CS | 1 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Normal | 52 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, NCS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Normal | 49 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, NCS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, CS | 0 Participants |
| Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Normal | 48 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Normal | 45 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, CS | 3 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, NCS | 1 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, NCS | 1 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Normal | 42 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Normal | 48 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Normal | 44 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Normal | 47 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, NCS | 5 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, NCS | 2 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, NCS | 4 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, CS | 1 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, NCS | 3 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Normal | 48 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, CS | 1 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Normal | 51 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, NCS | 3 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, NCS | 3 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, NCS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Normal | 47 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Normal | 47 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, NCS | 1 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Normal | 41 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Normal | 49 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, NCS | 1 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, NCS | 2 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, NCS | 10 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, NCS | 2 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Normal | 49 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Normal | 50 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Missing | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Normal | 47 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/Somapacitan | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Normal | 46 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Normal | 14 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Normal | 16 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, NCS | 1 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Abnormal, CS | 1 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Normal | 15 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 0) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Central & Peripheral nervous sys. (week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Normal | 11 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Normal | 16 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, NCS | 4 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Abnormal, CS | 1 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 88) | Normal | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Skin (Week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Abnormal, NCS | 1 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Normal | 16 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Head, neck, eyes, nose (Week 0) | Normal | 15 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, NCS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Respiratory sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Normal | 14 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 0) | Abnormal, NCS | 1 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Lymph node palpation (week 0) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Abnormal, NCS | 2 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Musculoskeletal sys. (Week 0) | Missing | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Cardiovascular sys. (Week 88) | Abnormal, CS | 0 Participants |
| Norditropin/- | Change in Physical Examination During Exposure to Trial Product (Week 88) | Gastrointestinal sys. (Week 88) | Abnormal, NCS | 0 Participants |
Secondary
Change in Potassium (Week 34)
Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Potassium (Week 34) | 0.02 mmol/L | Standard Deviation 0.44 |
| Norditropin | Change in Potassium (Week 34) | -0.06 mmol/L | Standard Deviation 0.39 |
| Somapacitan | Change in Potassium (Week 34) | 0.04 mmol/L | Standard Deviation 9.42 |
Secondary
Change in Potassium (Week 87)
Change in Potassium was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Potassium (Week 87) | -0.06 mmol/L | Standard Deviation 0.45 |
| Norditropin | Change in Potassium (Week 87) | 0.00 mmol/L | Standard Deviation 0.44 |
| Somapacitan | Change in Potassium (Week 87) | -0.00 mmol/L | Standard Deviation 0.4 |
| Norditropin/Somapacitan | Change in Potassium (Week 87) | -0.03 mmol/L | Standard Deviation 0.43 |
Secondary
Change in Pulse (Week 35)
Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time frame: Week -3, week 35
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Pulse (Week 35) | 0.54 beats/min | Standard Deviation 9.43 |
| Norditropin | Change in Pulse (Week 35) | 2.61 beats/min | Standard Deviation 9.74 |
| Somapacitan | Change in Pulse (Week 35) | 1.02 beats/min | Standard Deviation 10.2 |
Secondary
Change in Pulse (Week 88)
Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Time frame: Week -3, week 88
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Pulse (Week 88) | 0.78 beats/min | Standard Deviation 11.7 |
| Norditropin | Change in Pulse (Week 88) | -0.55 beats/min | Standard Deviation 10.51 |
| Somapacitan | Change in Pulse (Week 88) | -0.55 beats/min | Standard Deviation 10.32 |
| Norditropin/Somapacitan | Change in Pulse (Week 88) | 0.08 beats/min | Standard Deviation 8.75 |
Secondary
Change in SF-36v2 (Summary and Domain Scores) (Week 34)
SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time frame: Week 0, week 34
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Overall physical | 2.01 Scores on scale | Standard Deviation 6.22 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Physical functioning | 2.19 Scores on scale | Standard Deviation 6.44 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Vitality | 3.21 Scores on scale | Standard Deviation 7.67 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to physical health | 2.49 Scores on scale | Standard Deviation 7.68 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to mental health | 0.85 Scores on scale | Standard Deviation 9.59 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Overall mental | 1.28 Scores on scale | Standard Deviation 8.72 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | General health | 1.50 Scores on scale | Standard Deviation 7.25 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Social functioning | 0.10 Scores on scale | Standard Deviation 10.43 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to emotional health | 2.29 Scores on scale | Standard Deviation 9.52 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Bodily pain | 0.63 Scores on scale | Standard Deviation 8.79 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Bodily pain | 2.19 Scores on scale | Standard Deviation 9.5 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | General health | 4.47 Scores on scale | Standard Deviation 7.64 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to physical health | 3.95 Scores on scale | Standard Deviation 8.48 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Overall physical | 2.87 Scores on scale | Standard Deviation 6.33 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Overall mental | 4.09 Scores on scale | Standard Deviation 10.19 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to emotional health | 3.50 Scores on scale | Standard Deviation 10.87 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Vitality | 5.26 Scores on scale | Standard Deviation 9.89 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to mental health | 3.72 Scores on scale | Standard Deviation 10.17 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Physical functioning | 2.46 Scores on scale | Standard Deviation 7.08 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Social functioning | 3.19 Scores on scale | Standard Deviation 9.8 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Overall mental | 2.70 Scores on scale | Standard Deviation 9.29 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Physical functioning | 3.18 Scores on scale | Standard Deviation 7.67 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to physical health | 3.14 Scores on scale | Standard Deviation 9.06 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to emotional health | 3.06 Scores on scale | Standard Deviation 11.6 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Role limitations due to mental health | 2.78 Scores on scale | Standard Deviation 9.56 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Social functioning | 2.87 Scores on scale | Standard Deviation 9.69 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Bodily pain | 1.79 Scores on scale | Standard Deviation 9.52 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | General health | 1.85 Scores on scale | Standard Deviation 7.58 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Overall physical | 2.40 Scores on scale | Standard Deviation 6.53 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | Vitality | 2.38 Scores on scale | Standard Deviation 8.56 |
Secondary
Change in SF-36v2 (Summary and Domain Scores) (Week 87)
SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Time frame: week 0, week 87
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to mental health | 2.80 Score on scale | Standard Deviation 10.55 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | General health | 3.46 Score on scale | Standard Deviation 7.33 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Social functioning | 3.84 Score on scale | Standard Deviation 10.36 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall mental score | 4.51 Score on scale | Standard Deviation 10.39 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to physical health | 3.31 Score on scale | Standard Deviation 9.81 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Physical functioning | 2.87 Score on scale | Standard Deviation 8.13 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to emotional health | 3.46 Score on scale | Standard Deviation 11.59 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall physical score | 2.66 Score on scale | Standard Deviation 6.91 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Vitality | 6.71 Score on scale | Standard Deviation 11.01 |
| Placebo | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Bodily pain | 1.41 Score on scale | Standard Deviation 8.57 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Vitality | 4.18 Score on scale | Standard Deviation 9.3 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to mental health | 3.66 Score on scale | Standard Deviation 8.12 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall physical score | 2.98 Score on scale | Standard Deviation 7.24 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | General health | 3.32 Score on scale | Standard Deviation 7.7 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Social functioning | 3.44 Score on scale | Standard Deviation 10.29 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Bodily pain | 1.47 Score on scale | Standard Deviation 10.29 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to emotional health | 3.46 Score on scale | Standard Deviation 12.25 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Physical functioning | 3.83 Score on scale | Standard Deviation 7.66 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to physical health | 4.16 Score on scale | Standard Deviation 10.1 |
| Norditropin | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall mental score | 3.56 Score on scale | Standard Deviation 9.06 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall mental score | 7.50 Score on scale | Standard Deviation 13.59 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Physical functioning | 3.43 Score on scale | Standard Deviation 6.96 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to mental health | 6.12 Score on scale | Standard Deviation 13.02 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to physical health | 4.65 Score on scale | Standard Deviation 10.06 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to emotional health | 7.30 Score on scale | Standard Deviation 13.46 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Vitality | 8.16 Score on scale | Standard Deviation 12.77 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Bodily pain | 3.51 Score on scale | Standard Deviation 9.57 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | General health | 5.66 Score on scale | Standard Deviation 9.67 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall physical score | 3.06 Score on scale | Standard Deviation 7.07 |
| Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Social functioning | 4.56 Score on scale | Standard Deviation 10.34 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Vitality | 4.16 Score on scale | Standard Deviation 8.88 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Physical functioning | 1.84 Score on scale | Standard Deviation 8.07 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | General health | 2.20 Score on scale | Standard Deviation 8.66 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to emotional health | 1.13 Score on scale | Standard Deviation 11.2 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to physical health | 2.45 Score on scale | Standard Deviation 10.5 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall mental score | 1.66 Score on scale | Standard Deviation 10.18 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Social functioning | 0.57 Score on scale | Standard Deviation 11.26 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Overall physical score | 1.81 Score on scale | Standard Deviation 7.72 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Bodily pain | 0.30 Score on scale | Standard Deviation 11.25 |
| Norditropin/Somapacitan | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | Role limitations due to mental health | 1.70 Score on scale | Standard Deviation 10.31 |
Secondary
Change in Sodium (Week 34)
Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Sodium (Week 34) | 0.1 mmol/L | Standard Deviation 2.4 |
| Norditropin | Change in Sodium (Week 34) | 0.1 mmol/L | Standard Deviation 2.9 |
| Somapacitan | Change in Sodium (Week 34) | 0.5 mmol/L | Standard Deviation 2.7 |
Secondary
Change in Sodium (Week 87)
Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Sodium (Week 87) | -0.7 mmol/L | Standard Deviation 3.35 |
| Norditropin | Change in Sodium (Week 87) | 0.0 mmol/L | Standard Deviation 2.92 |
| Somapacitan | Change in Sodium (Week 87) | -0.3 mmol/L | Standard Deviation 2.74 |
| Norditropin/Somapacitan | Change in Sodium (Week 87) | 0.5 mmol/L | Standard Deviation 2.76 |
Secondary
Change in Steady State Beta Cell Function (%B) (Week 34)
Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Steady State Beta Cell Function (%B) (Week 34) | 27.10 Percentage of beta cell function | Standard Deviation 105.45 |
| Norditropin | Change in Steady State Beta Cell Function (%B) (Week 34) | 36.26 Percentage of beta cell function | Standard Deviation 290 |
| Somapacitan | Change in Steady State Beta Cell Function (%B) (Week 34) | 54.90 Percentage of beta cell function | Standard Deviation 173.14 |
Secondary
Change in Steady State Beta Cell Function (%B) (Week 87)
Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Steady State Beta Cell Function (%B) (Week 87) | 21.72 Percentage of beta cell function | Standard Deviation 154.22 |
| Norditropin | Change in Steady State Beta Cell Function (%B) (Week 87) | -16.54 Percentage of beta cell function | Standard Deviation 148.72 |
| Somapacitan | Change in Steady State Beta Cell Function (%B) (Week 87) | -7.34 Percentage of beta cell function | Standard Deviation 97.62 |
| Norditropin/Somapacitan | Change in Steady State Beta Cell Function (%B) (Week 87) | 34.54 Percentage of beta cell function | Standard Deviation 161.01 |
Secondary
Change in Systolic Blood Pressure (Week 35)
Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Time frame: Week -3, week 35
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Systolic Blood Pressure (Week 35) | 1.13 mm Hg | Standard Deviation 11.35 |
| Norditropin | Change in Systolic Blood Pressure (Week 35) | -2.81 mm Hg | Standard Deviation 13.33 |
| Somapacitan | Change in Systolic Blood Pressure (Week 35) | -1.39 mm Hg | Standard Deviation 12.89 |
Secondary
Change in Systolic Blood Pressure (Week 88)
Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Time frame: Week -3, week 88
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Systolic Blood Pressure (Week 88) | -1.30 mm Hg | Standard Deviation 12.18 |
| Norditropin | Change in Systolic Blood Pressure (Week 88) | 0.45 mm Hg | Standard Deviation 13.01 |
| Somapacitan | Change in Systolic Blood Pressure (Week 88) | -1.35 mm Hg | Standard Deviation 13.07 |
| Norditropin/Somapacitan | Change in Systolic Blood Pressure (Week 88) | -1.83 mm Hg | Standard Deviation 11.63 |
Secondary
Change in Thrombocytes (Week 34)
Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Thrombocytes (Week 34) | 1.6 10^9 cells/L | Standard Deviation 37.4 |
| Norditropin | Change in Thrombocytes (Week 34) | 10.8 10^9 cells/L | Standard Deviation 37.1 |
| Somapacitan | Change in Thrombocytes (Week 34) | 15.3 10^9 cells/L | Standard Deviation 35 |
Secondary
Change in Thrombocytes (Week 87)
Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Thrombocytes (Week 87) | -1.2 10^9 cells/L | Standard Deviation 44.7 |
| Norditropin | Change in Thrombocytes (Week 87) | 11.0 10^9 cells/L | Standard Deviation 36.7 |
| Somapacitan | Change in Thrombocytes (Week 87) | -0.9 10^9 cells/L | Standard Deviation 31.3 |
| Norditropin/Somapacitan | Change in Thrombocytes (Week 87) | 6.6 10^9 cells/L | Standard Deviation 53.4 |
Secondary
Change in Total Cholesterol (Week 34)
Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Cholesterol (Week 34) | 0.03 mmol/L | Standard Deviation 0.96 |
| Norditropin | Change in Total Cholesterol (Week 34) | -0.10 mmol/L | Standard Deviation 0.91 |
| Somapacitan | Change in Total Cholesterol (Week 34) | -0.09 mmol/L | Standard Deviation 0.78 |
Secondary
Change in Total Cholesterol (Week 87)
Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Cholesterol (Week 87) | -0.21 mmol/L | Standard Deviation 0.89 |
| Norditropin | Change in Total Cholesterol (Week 87) | 0.03 mmol/L | Standard Deviation 0.96 |
| Somapacitan | Change in Total Cholesterol (Week 87) | -0.05 mmol/L | Standard Deviation 0.94 |
| Norditropin/Somapacitan | Change in Total Cholesterol (Week 87) | -0.33 mmol/L | Standard Deviation 1.08 |
Secondary
Change in Total Fat Mass (Week 34)
Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Fat Mass (Week 34) | 305.47 grams | Standard Deviation 2689.06 |
| Norditropin | Change in Total Fat Mass (Week 34) | -855.71 grams | Standard Deviation 3167.06 |
| Somapacitan | Change in Total Fat Mass (Week 34) | -85.47 grams | Standard Deviation 3022.71 |
Secondary
Change in Total Fat Mass (Week 87)
Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: Week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Fat Mass (Week 87) | -540.04 grams | Standard Deviation 3250.16 |
| Norditropin | Change in Total Fat Mass (Week 87) | -118.07 grams | Standard Deviation 3795.36 |
| Somapacitan | Change in Total Fat Mass (Week 87) | -923.01 grams | Standard Deviation 4099.45 |
| Norditropin/Somapacitan | Change in Total Fat Mass (Week 87) | 874.56 grams | Standard Deviation 4789.34 |
Secondary
Change in Total Protein (Week 34)
Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Protein (Week 34) | -0.26 g/L | Standard Deviation 5.48 |
| Norditropin | Change in Total Protein (Week 34) | -0.97 g/L | Standard Deviation 4.36 |
| Somapacitan | Change in Total Protein (Week 34) | -0.83 g/L | Standard Deviation 4.93 |
Secondary
Change in Total Protein (Week 87)
Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Total Protein (Week 87) | -1.20 g/L | Standard Deviation 5.17 |
| Norditropin | Change in Total Protein (Week 87) | -0.74 g/L | Standard Deviation 4.88 |
| Somapacitan | Change in Total Protein (Week 87) | -1.31 g/L | Standard Deviation 4.91 |
| Norditropin/Somapacitan | Change in Total Protein (Week 87) | -1.59 g/L | Standard Deviation 4.37 |
Secondary
Change in Triglycerides (Week 34)
Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Triglycerides (Week 34) | 0.01 mmol/L | Standard Deviation 0.65 |
| Norditropin | Change in Triglycerides (Week 34) | 0.13 mmol/L | Standard Deviation 0.62 |
| Somapacitan | Change in Triglycerides (Week 34) | -0.02 mmol/L | Standard Deviation 0.73 |
Secondary
Change in Triglycerides (Week 87)
Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Triglycerides (Week 87) | 0.07 mmol/L | Standard Deviation 0.48 |
| Norditropin | Change in Triglycerides (Week 87) | 0.03 mmol/L | Standard Deviation 0.76 |
| Somapacitan | Change in Triglycerides (Week 87) | 0.03 mmol/L | Standard Deviation 0.56 |
| Norditropin/Somapacitan | Change in Triglycerides (Week 87) | -0.08 mmol/L | Standard Deviation 0.73 |
Secondary
Change in TRIM-AGHD (Total and Domain Scores) (Week 34)
Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Time frame: Week 0, week 34
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Physical | -5.88 Scores on a scale | Standard Deviation 14.72 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Cognitive | -2.25 Scores on a scale | Standard Deviation 18.17 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Energy | -3.96 Scores on a scale | Standard Deviation 25.4 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Psychological | -3.38 Scores on a scale | Standard Deviation 12.15 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Total | -3.65 Scores on a scale | Standard Deviation 12.05 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Cognitive | -7.06 Scores on a scale | Standard Deviation 18.47 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Energy | -13.42 Scores on a scale | Standard Deviation 23.73 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Psychological | -8.93 Scores on a scale | Standard Deviation 14.21 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Physical | -11.33 Scores on a scale | Standard Deviation 19.23 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Total | -9.99 Scores on a scale | Standard Deviation 13.64 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Total | -5.71 Scores on a scale | Standard Deviation 12.69 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Physical | -7.39 Scores on a scale | Standard Deviation 19.25 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Energy | -7.81 Scores on a scale | Standard Deviation 24.07 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Cognitive | -3.92 Scores on a scale | Standard Deviation 17.29 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Psychological | -4.63 Scores on a scale | Standard Deviation 12.01 |
Secondary
Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Time frame: week 0, week 87
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Cognitive | -4.88 Scores on scale | Standard Deviation 21.19 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Physical | -11.19 Scores on scale | Standard Deviation 20.13 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Total | -8.28 Scores on scale | Standard Deviation 15.88 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Psychological | -6.97 Scores on scale | Standard Deviation 16.05 |
| Placebo | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Energy | -11.73 Scores on scale | Standard Deviation 30.87 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Psychological | -6.64 Scores on scale | Standard Deviation 14.56 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Cognitive | -5.55 Scores on scale | Standard Deviation 18.59 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Energy | -8.11 Scores on scale | Standard Deviation 25.46 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Physical | -9.57 Scores on scale | Standard Deviation 21.94 |
| Norditropin | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Total | -7.25 Scores on scale | Standard Deviation 14.42 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Physical | -17.22 Scores on scale | Standard Deviation 27.02 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Energy | -23.30 Scores on scale | Standard Deviation 28.03 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Psychological | -15.64 Scores on scale | Standard Deviation 15.36 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Cognitive | -14.18 Scores on scale | Standard Deviation 20.29 |
| Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Total | -17.38 Scores on scale | Standard Deviation 16.77 |
| Norditropin/Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Psychological | -7.35 Scores on scale | Standard Deviation 10.5 |
| Norditropin/Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Energy | -9.13 Scores on scale | Standard Deviation 26.98 |
| Norditropin/Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Physical | -13.54 Scores on scale | Standard Deviation 18.02 |
| Norditropin/Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Total | -8.67 Scores on scale | Standard Deviation 11.73 |
| Norditropin/Somapacitan | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Cognitive | -7.71 Scores on scale | Standard Deviation 14.14 |
Secondary
Change in Truncal Fat Mass (Week 34)
Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Truncal Fat Mass (Week 34) | 417.86 grams | Standard Deviation 1536.36 |
| Norditropin | Change in Truncal Fat Mass (Week 34) | -619.67 grams | Standard Deviation 1887.5 |
| Somapacitan | Change in Truncal Fat Mass (Week 34) | -180.98 grams | Standard Deviation 1762.31 |
Secondary
Change in Truncal Fat Mass (Week 87)
Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Truncal Fat Mass (Week 87) | -311.85 grams | Standard Deviation 1771.78 |
| Norditropin | Change in Truncal Fat Mass (Week 87) | -196.18 grams | Standard Deviation 2249.21 |
| Somapacitan | Change in Truncal Fat Mass (Week 87) | -685.56 grams | Standard Deviation 2258.93 |
| Norditropin/Somapacitan | Change in Truncal Fat Mass (Week 87) | 364.08 grams | Standard Deviation 2548.85 |
Secondary
Change in Truncal Fat Percentage (Week 87)
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Truncal Fat Percentage (Week 87) | -2.16 Percentage of truncal fat | Standard Deviation 3.94 |
| Norditropin | Change in Truncal Fat Percentage (Week 87) | -1.63 Percentage of truncal fat | Standard Deviation 3.65 |
| Somapacitan | Change in Truncal Fat Percentage (Week 87) | -2.63 Percentage of truncal fat | Standard Deviation 4.65 |
| Norditropin/Somapacitan | Change in Truncal Fat Percentage (Week 87) | -0.96 Percentage of truncal fat | Standard Deviation 4.51 |
Secondary
Change in Truncal Lean Body Mass (Week 34)
Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Truncal Lean Body Mass (Week 34) | 402.69 grams | Standard Deviation 1247.67 |
| Norditropin | Change in Truncal Lean Body Mass (Week 34) | 832.77 grams | Standard Deviation 1409.74 |
| Somapacitan | Change in Truncal Lean Body Mass (Week 34) | 800.27 grams | Standard Deviation 1377.75 |
Secondary
Change in Truncal Lean Body Mass (Week 87)
Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Truncal Lean Body Mass (Week 87) | 1197.30 grams | Standard Deviation 1500.56 |
| Norditropin | Change in Truncal Lean Body Mass (Week 87) | 1152.79 grams | Standard Deviation 1480.06 |
| Somapacitan | Change in Truncal Lean Body Mass (Week 87) | 975.79 grams | Standard Deviation 1258.62 |
| Norditropin/Somapacitan | Change in Truncal Lean Body Mass (Week 87) | 1015.12 grams | Standard Deviation 1554.88 |
Secondary
Change in Urea (Week 34)
Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Urea (Week 34) | 0.17 mmol/L | Standard Deviation 1.27 |
| Norditropin | Change in Urea (Week 34) | -0.40 mmol/L | Standard Deviation 1.16 |
| Somapacitan | Change in Urea (Week 34) | -0.19 mmol/L | Standard Deviation 1.24 |
Secondary
Change in Urea (Week 87)
Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Urea (Week 87) | 0.11 mmol/L | Standard Deviation 1.4 |
| Norditropin | Change in Urea (Week 87) | -0.21 mmol/L | Standard Deviation 1.28 |
| Somapacitan | Change in Urea (Week 87) | -0.26 mmol/L | Standard Deviation 1.35 |
| Norditropin/Somapacitan | Change in Urea (Week 87) | -0.03 mmol/L | Standard Deviation 2.46 |
Secondary
Change in Uric Acid (Week 34)
Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Uric Acid (Week 34) | -8.228 umol/L | Standard Deviation 52.557 |
| Norditropin | Change in Uric Acid (Week 34) | -12.61 umol/L | Standard Deviation 50.534 |
| Somapacitan | Change in Uric Acid (Week 34) | -21.11 umol/L | Standard Deviation 57.594 |
Secondary
Change in Uric Acid (Week 87)
Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Uric Acid (Week 87) | -25.22 umol/L | Standard Deviation 59.042 |
| Norditropin | Change in Uric Acid (Week 87) | -21.95 umol/L | Standard Deviation 58.903 |
| Somapacitan | Change in Uric Acid (Week 87) | -18.02 umol/L | Standard Deviation 59.716 |
| Norditropin/Somapacitan | Change in Uric Acid (Week 87) | -31.31 umol/L | Standard Deviation 86.787 |
Secondary
Change in Visceral Adipose Tissue (Week 34)
Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Visceral Adipose Tissue (Week 34) | 4.41 centimeter square | Standard Deviation 13.81 |
| Norditropin | Change in Visceral Adipose Tissue (Week 34) | -9.68 centimeter square | Standard Deviation 21.37 |
| Somapacitan | Change in Visceral Adipose Tissue (Week 34) | -11.61 centimeter square | Standard Deviation 23.93 |
Secondary
Change in Visceral Adipose Tissue (Week 87)
Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: Week -3, week 87
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Visceral Adipose Tissue (Week 87) | -9.34 centimeter square | Standard Deviation 25.67 |
| Norditropin | Change in Visceral Adipose Tissue (Week 87) | -6.71 centimeter square | Standard Deviation 33.07 |
| Somapacitan | Change in Visceral Adipose Tissue (Week 87) | -5.17 centimeter square | Standard Deviation 20.11 |
| Norditropin/Somapacitan | Change in Visceral Adipose Tissue (Week 87) | -5.97 centimeter square | Standard Deviation 28.86 |
Secondary
Change in Waist Circumference (Week 34)
Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).
Time frame: Week -3, week 34
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Waist Circumference (Week 34) | 0.82 cm | Standard Deviation 4.5 |
| Norditropin | Change in Waist Circumference (Week 34) | -0.66 cm | Standard Deviation 4.83 |
| Somapacitan | Change in Waist Circumference (Week 34) | -0.00 cm | Standard Deviation 4.52 |
Secondary
Change in Waist Circumference (Week 87)
Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Time frame: week -3, week 87
Population: Overall number of participants analysed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Waist Circumference (Week 87) | 1.35 cm | Standard Deviation 5.62 |
| Norditropin | Change in Waist Circumference (Week 87) | 0.53 cm | Standard Deviation 5.17 |
| Somapacitan | Change in Waist Circumference (Week 87) | -2.26 cm | Standard Deviation 7.93 |
| Norditropin/Somapacitan | Change in Waist Circumference (Week 87) | 0.74 cm | Standard Deviation 7.17 |
Secondary
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)
Incidence of technical complaints were recorded from baseline (week 0) until week 35.
Time frame: Weeks 0 to 35
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) | 1 Technical complaints |
| Norditropin | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) | 14 Technical complaints |
| Somapacitan | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) | 0 Technical complaints |
Secondary
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)
Incidence of technical complaints were recorded from baseline (week 0) until week 88.
Time frame: Weeks 0 to 88
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) | 1 Technical complaints |
| Norditropin | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) | 6 Technical complaints |
| Somapacitan | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) | 18 Technical complaints |
| Norditropin/Somapacitan | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) | 7 Technical complaints |
Secondary
Number of Adverse Events (Weeks 0-35)
Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.
Time frame: Weeks 0-35
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Adverse Events (Weeks 0-35) | 184 Events |
| Norditropin | Number of Adverse Events (Weeks 0-35) | 426 Events |
| Somapacitan | Number of Adverse Events (Weeks 0-35) | 385 Events |
Secondary
Number of Adverse Events (Weeks 0-88)
Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.
Time frame: Weeks 0-88
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Adverse Events (Weeks 0-88) | 395 Events |
| Norditropin | Number of Adverse Events (Weeks 0-88) | 699 Events |
| Somapacitan | Number of Adverse Events (Weeks 0-88) | 384 Events |
| Norditropin/Somapacitan | Number of Adverse Events (Weeks 0-88) | 385 Events |
| Norditropin/- | Number of Adverse Events (Weeks 0-88) | 49 Events |
Secondary
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Time frame: Weeks 0 to 35
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) | 0 Participants |
| Norditropin | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) | 1 Participants |
| Somapacitan | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) | 0 Participants |
Secondary
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Time frame: Weeks 0 to 88
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | 0 Participants |
| Norditropin | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | 0 Participants |
| Somapacitan | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | 0 Participants |
| Norditropin/Somapacitan | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | 0 Participants |
| Norditropin/- | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | 1 Participants |
Secondary
TSQM-9 Scores (Domain Scores) (Week 34)
Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Time frame: Week 34
Population: Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | TSQM-9 Scores (Domain Scores) (Week 34) | Effectiveness | 49.6 Scores on a scale | Standard Deviation 22.2 |
| Placebo | TSQM-9 Scores (Domain Scores) (Week 34) | Global satisfaction | 54.0 Scores on a scale | Standard Deviation 24.8 |
| Placebo | TSQM-9 Scores (Domain Scores) (Week 34) | Convenience | 74.3 Scores on a scale | Standard Deviation 16.9 |
| Norditropin | TSQM-9 Scores (Domain Scores) (Week 34) | Convenience | 73.9 Scores on a scale | Standard Deviation 18.7 |
| Norditropin | TSQM-9 Scores (Domain Scores) (Week 34) | Effectiveness | 67.1 Scores on a scale | Standard Deviation 21.8 |
| Norditropin | TSQM-9 Scores (Domain Scores) (Week 34) | Global satisfaction | 69.0 Scores on a scale | Standard Deviation 24 |
| Somapacitan | TSQM-9 Scores (Domain Scores) (Week 34) | Global satisfaction | 63.1 Scores on a scale | Standard Deviation 24.2 |
| Somapacitan | TSQM-9 Scores (Domain Scores) (Week 34) | Effectiveness | 56.1 Scores on a scale | Standard Deviation 22.5 |
| Somapacitan | TSQM-9 Scores (Domain Scores) (Week 34) | Convenience | 77.7 Scores on a scale | Standard Deviation 15.3 |
Secondary
TSQM-9 Scores (Domain Scores) (Week 87)
Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Time frame: Week 87
Population: Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | TSQM-9 Scores (Domain Scores) (Week 87) | Global satisfaction | 63.2 Scores on a scale | Standard Deviation 26.2 |
| Placebo | TSQM-9 Scores (Domain Scores) (Week 87) | Effectiveness | 59.7 Scores on a scale | Standard Deviation 23.1 |
| Placebo | TSQM-9 Scores (Domain Scores) (Week 87) | Convenience | 75.1 Scores on a scale | Standard Deviation 19.1 |
| Norditropin | TSQM-9 Scores (Domain Scores) (Week 87) | Convenience | 80.0 Scores on a scale | Standard Deviation 16.5 |
| Norditropin | TSQM-9 Scores (Domain Scores) (Week 87) | Effectiveness | 65.7 Scores on a scale | Standard Deviation 22.4 |
| Norditropin | TSQM-9 Scores (Domain Scores) (Week 87) | Global satisfaction | 68.1 Scores on a scale | Standard Deviation 24.6 |
| Somapacitan | TSQM-9 Scores (Domain Scores) (Week 87) | Convenience | 72.6 Scores on a scale | Standard Deviation 20 |
| Somapacitan | TSQM-9 Scores (Domain Scores) (Week 87) | Effectiveness | 69.6 Scores on a scale | Standard Deviation 24 |
| Somapacitan | TSQM-9 Scores (Domain Scores) (Week 87) | Global satisfaction | 71.7 Scores on a scale | Standard Deviation 25.3 |
| Norditropin/Somapacitan | TSQM-9 Scores (Domain Scores) (Week 87) | Effectiveness | 70.9 Scores on a scale | Standard Deviation 20.9 |
| Norditropin/Somapacitan | TSQM-9 Scores (Domain Scores) (Week 87) | Global satisfaction | 75.1 Scores on a scale | Standard Deviation 23.6 |
| Norditropin/Somapacitan | TSQM-9 Scores (Domain Scores) (Week 87) | Convenience | 79.4 Scores on a scale | Standard Deviation 17.1 |