A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Study Overview
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Brief Summary
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This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.

Official Title
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A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Conditions
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Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
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* Drug: somapacitan
* Drug: Norditropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - 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 Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ 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 medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somapacitan<br> | Drug: somapacitan<br>* Once weekly subcutaneous injections (s.c., under the skin)<br>|
| Active Comparator: Norditropin<br> | Drug: Norditropin<br>* Daily subcutaneous injections (s.c., under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events, Including Injection Site Reactions | An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented. | Weeks 0-53 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cross-sectional Total Adipose Tissue Compartments | Cross-sectional total adipose tissue compartments (TAT) were determined by quantitative computed tomography (CT) scans. Change from baseline (week 0) to end of treatment period (52 weeks) in cross-sectional TAT compartments is presented. | Week 0, week 52 | 
| Change in Subcutaneous Adipose Tissue Compartments | Subcutaneous adipose tissue compartments (SAT) was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in SAT compartments is presented. | Week 0, week 52 | 
| Change in Intra-abdominal or Visceral Adipose Tissue Compartments | Intra-abdominal or visceral adipose tissue (VAT) compartments was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in VAT compartments is presented. | Week 0, week 52 | 
| Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores | 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 effectiveness of the medication, convenience and global satisfaction of treatment. 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 TSQM-9 scores from baseline (week 0) to week 52 are presented. | Week 0, week 52 | 
| Change in Physical Examination | Physical examination parameters were evaluated for head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system, gastrointestinal system, incl. mouth; musculoskeletal system; nervous system (central and peripheral); skin; and lymph node palpation. The investigator evaluated the findings from the physical examination and classifies them as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Results are presented for week 0 and week 52. | Week 0, week 52 | 
| Change in Body Weight | Change from baseline (week -3) in body weight at week 52 is presented. | Week -3, week 52 | 
| Change in SBP and DBP | Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented. | Week 0, week 52 | 
| Change in Pulse | Change from baseline (week 0) in pulse at week 52 is presented. | Week 0, week 52 | 
| Change in ECG | The ECG was assessed by the investigator at baseline (week -3) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at week -3 and week 52 are presented. | Week -3, week 52 | 
| Change in Haematology: Haemoglobin | Change from baseline (week -3) in haemoglobin at week 52 is presented. | Week -3, week 52 | 
| Change in Haematology: Haematocrit | Change from baseline (week -3) in haematocrit at week 52 is presented. | Week -3, week 52 | 
| Change in Haematology: Thrombocytes, Leucocytes | Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented. | Week -3, week 52 | 
| Change in Haematology: Erythrocytes | Change from baseline (week -3) in erythrocytes at week 52 is presented. | Week -3, week 52 | 
| Change in Haematology: Mean Corpuscular Volume | Change from baseline (week -3) in mean corpuscular volume at week 52 is presented. | Week -3, week 52 | 
| Change in Haematology: Mean Corpuscular Haemoglobin Concentration | Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented. | Week -3, week 52 | 
| Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) | Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented. | Week -3, week 52 | 
| Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT | Change from baseline (week -3) in creatinine kinase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at week 52 is presented. | Week -3, week 52 | 
| Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) | Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented. | Week -3, week 52 | 
| Change in Biochemistry: Total Protein and Albumin | Change from baseline (week -3) in total protein and albumin at week 52 is presented. | Week -3, week 52 | 
| Change in Biochemistry: eGFR Creatinine | Estimated glomerular filtration rate (eGFR) creatinine (measured in milliliters per minute per 1.73 square meters [mL/min/1.73m^2]) was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change from baseline (week -3) in eGFR at week 52 is presented. | Week -3, week 52 | 
| Change in HbA1c | Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented. | Week -3, week 52 | 
| Change in FPG | Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented. | Week -3, week 52 | 
| Change in Fasting Insulin | Change from baseline (week -3) in fasting insulin at week 52 is presented. | Week -3, week 52 | 
| Change in Steady State Beta Cell Function | Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented. | Week -3, week 52 | 
| Change in Insulin Resistance | Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented. | Week -3, week 52 | 
| Occurrence of Anti-somapacitan Antibodies | Number of participants with anti-somapacitan antibodies at baseline (week 0) and week 53 are presented. This outcome measure is applicable only for the treatment arm Somapacitan. | Weeks 0 - 53 | 
| Occurrence of Anti-hGH Antibodies | Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented. | Weeks 0 - 53 | 
| Incidence of Clinical Technical Complaints | A technical complaint was any written, electronic, or oral communication that alleged product (medicine or device) defects. Number of partipants who reported technical complaints during the course of the trial are presented. | Weeks 0 - 53 |