CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
somapacitan +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02229851
NCT02229851Phase 3Completed
CompareCT.gov

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Novo Nordisk A/S·interventional·Posted Sep 3, 2014·Updated Nov 23, 2020

In Brief

A Phase 3 clinical trial evaluating somapacitan, somatropin, and 1 other intervention for Growth Hormone Disorder and Adult Growth Hormone Deficiency. Completed, enrolled 301 participants across 117 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Disorder, Adult Growth Hormone Deficiency
CountriesAustralia, Brazil, Germany, India, Israel, Japan, Latvia, Lithuania, Malaysia, Norway, Poland, Romania, Russia, South Africa, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 3, 2014
Enrollment StartOct 31, 2014
Primary CompletionApr 21, 2017
Study CompletionMay 7, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.8 years ago

Interventions

somapacitandrug

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.

somatropindrug

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.

placebodrug

Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.