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

Phase 2 Active not recruiting 62 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-07-04
Primary completion: 2021-05-05
Completion: 2026-12-23

Publications

Juul A, Hojby M, Kawai M, Linglart A, Mori J, Zuckerman-Levin N, Backeljauw P. Somapacitan in children born small for gestational age: 4-year results from phase 2. Eur J Endocrinol. 2026 Feb 4;194(2):157-169. doi: 10.1093/ejendo/lvag017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Somatropin	Protein / enzyme biologic	0.035 mg/kg	Subcutaneous
Comparator	Somatropin	Protein / enzyme biologic	0.067 mg/kg	Subcutaneous
Subject	somapacitan	Protein / enzyme biologic	0.16 mg/kg	Subcutaneous
Subject	somapacitan	Protein / enzyme biologic	0.2 mg/kg	Subcutaneous
Subject	somapacitan	Protein / enzyme biologic	0.24 mg/kg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications