Completed
PHASE1
INTERVENTIONAL
NCT01973244
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.
Interventions
Name:
somapacitan
Type:
DRUG
Description:
A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.
Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation.
Name:
somatropin
Type:
DRUG
Description:
Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.
Primary Outcomes
Measure:
Incidence of adverse events (AEs)
TimeFrame:
From first administration of trial product and up until day 35 (final visit)
Description:
Trial Information
NCT ID
NCT01973244
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025