Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT05330325
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.
Interventions
Name:
Somapacitan
Type:
DRUG
Description:
Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.
Name:
Norditropin®
Type:
DRUG
Description:
Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.
Primary Outcomes
Measure:
Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS)
TimeFrame:
From baseline (week 0) to visit 7 (week 52)
Description:
Measured in centimeter per year (cm/year)
Trial Information
NCT ID
NCT05330325
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025