NCT05723835

A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.

Conditions

• SGA
• Turner Syndrome
• Noonan Syndrome
• ISS

Interventions

Type	Name	Description
DRUG	Somapacitan	Somapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-06-07
• Completion: 2027-10-29
• First posted: 2023-02-13
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

17 sites across 6 countries: United States, Malaysia, Netherlands, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study