Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
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).
Interventions
DRUGsomapacitan
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
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
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | From first administration of trial product and up until Day 49 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h) | From 0 to 168 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 |
| Norditropin NordiFlex®: Cmax | From 0 to 24 hours |
Countries
Denmark, Sweden
Outcome results
None listed