NCT03878446

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.

Conditions

• Short Stature Children Born Small for Gestational Age (SGA)

Interventions

Type	Name	Description
DRUG	Somapacitan	Somapacitan injected under the skin once a week.
DRUG	Norditropin®	Norditropin® injected under the skin once a day.

Timeline

• Start date: 2019-07-04
• Primary completion: 2021-05-05
• Completion: 2026-12-23
• First posted: 2019-03-18
• Last updated: 2025-12-23
• Results posted: 2024-06-20

Locations

92 sites across 23 countries: United States, Algeria, Austria, Canada, Denmark, Estonia, France, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Norway, Poland, Russia, Serbia, Spain, Switzerland, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study