CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
somapacitan +1 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/NCT02616562
NCT02616562Phase 2Completed
CompareCT.gov

A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Novo Nordisk A/S·interventional·Posted Nov 30, 2015·Updated Jan 16, 2026

In Brief

A Phase 2 clinical trial evaluating somapacitan and Norditropin® FlexPro® pen for Growth Hormone Disorder and Growth Hormone Deficiency in Children. Completed, enrolled 76 participants across 89 sites in 14 countries.

Detailed Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Disorder, Growth Hormone Deficiency in Children
CountriesAustria, Belgium, Brazil, Canada, France, Germany, India, Israel, Japan, Slovenia, Sweden, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 30, 2015
Enrollment StartMar 31, 2016
Primary CompletionSep 26, 2024
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 10.6 years ago

Interventions

somapacitandrug

Administered subcutaneously (s.c., under the skin) once-weekly.

Norditropin® FlexPro® pendrug

Administered subcutaneously (s.c., under the skin) once daily.