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

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.

Timeline

Start

2022-08-10

Primary completion

2024-08-05

Completion

2027-10-29

Publications

• Jorge AAL, Albanese A, Hojby M, Soltysik K, Edouard T, Grandone A, Tansey M, Mori J. Once-weekly somapacitan in children with Noonan syndrome: randomized controlled phase 3 trial. Eur J Endocrinol. 2026 Mar 4;194(3):393-403. doi: 10.1093/ejendo/lvag041.
• Abuzzahab J, Dauber A, Hojby M, Soltysik K, Kawai M, Murray PG, Phillip M, Battelino T. Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study. Eur J Endocrinol. 2026 Feb 4;194(2):242-253. doi: 10.1093/ejendo/lvag027.

Drugs

Indications