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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
København Ø, Denmark
Novo Nordisk Investigational Site
Odense, Denmark
Novo Nordisk Investigational Site
Stockholm, Sweden
Incidence of adverse events (AEs)
Time frame: From first administration of trial product and up until Day 49
NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)
Time frame: From 0 to 168 hours
Norditropin NordiFlex® only: AUC (0-24h)
Time frame: From 0 to 24 hours
NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)
Time frame: From 0 to 168 hours
Norditropin NordiFlex®, first dose administration only: AUC (0-24h)
Time frame: From 0 to 24 hours
NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)
Time frame: From 0 to 168 hours
Norditropin NordiFlex®: Cmax
Time frame: From 0 to 24 hours
Insulin-like growth factor I (IGF-I): AUC (0-168h)
Time frame: From 0 to 168 hours
IGF-I: Cmax
Time frame: From 0 to 168 hours
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)
Time frame: From 0 to 168 hours
IGFBP-3: Cmax
Time frame: From 0 to 168 hours
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