NCT05330325

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children 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: 412 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SGA, Turner Syndrome, Noonan Syndrome, ISS

Interventions

Type	Name	Description
DRUG	Somapacitan	Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.
DRUG	Norditropin®	Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.

Timeline

• Start date: 2022-08-10
• Primary completion: 2024-08-05
• Completion: 2027-10-29
• First posted: 2022-04-15
• Last updated: 2026-03-13

Locations

199 sites across 33 countries: United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study