A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).

Official Title
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A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in 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 NordiFlex®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD Stable human growth hormone (hGH) replacement therapy for at least 3 months Exclusion Criteria: Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes Heart insufficiency, New York Heart Association (NYHA) class above 2 Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment Stable pituitary replacement therapy for less than 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: NNC0195-0092 (somapacitan)<br> | Drug: somapacitan<br>* Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order<br>* Other names: NNC0195-0092;|
| Active Comparator: Norditropin NordiFlex®<br> | Drug: Norditropin NordiFlex®<br>* Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | From first administration of trial product and up until Day 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h) |  | From 0 to 168 hours | 
| Norditropin NordiFlex® only: AUC (0-24h) |  | From 0 to 24 hours | 
| NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h) |  | From 0 to 168 hours | 
| Norditropin NordiFlex®, first dose administration only: AUC (0-24h) |  | From 0 to 24 hours | 
| NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax) |  | From 0 to 168 hours | 
| Norditropin NordiFlex®: Cmax |  | From 0 to 24 hours | 
| Insulin-like growth factor I (IGF-I): AUC (0-168h) |  | From 0 to 168 hours | 
| IGF-I: Cmax |  | From 0 to 168 hours | 
| Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h) |  | From 0 to 168 hours | 
| IGFBP-3: Cmax |  | From 0 to 168 hours |