NCT02616562

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Disorder
• Growth Hormone Deficiency in Children

Interventions

Type	Name	Description
DRUG	somapacitan	Administered subcutaneously (s.c., under the skin) once-weekly.
DRUG	Norditropin® FlexPro® pen	Administered subcutaneously (s.c., under the skin) once daily.

Timeline

• Start date: 2016-03-31
• Primary completion: 2024-09-26
• Completion: 2024-09-26
• First posted: 2015-11-30
• Last updated: 2026-01-16
• Results posted: 2026-01-16

Locations

89 sites across 14 countries: United States, Austria, Belgium, Brazil, Canada, France, Germany, India, Israel, Japan, Slovenia, Sweden, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study