Completed
PHASE3
INTERVENTIONAL
NCT02229851
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.
Interventions
Name:
somapacitan
Type:
DRUG
Description:
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
Name:
somatropin
Type:
DRUG
Description:
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.
Name:
placebo
Type:
DRUG
Description:
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
Primary Outcomes
Measure:
Change in Truncal Fat Percentage (Week 34)
TimeFrame:
Week -3, week 34
Description:
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Trial Information
NCT ID
NCT02229851
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025