NN8640-4245 - 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

Brief description of study

This research study involves children born small and who stayed small. Treatment is somapacitan once a week compared to Norditropin® once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin. The purpose of this study is to compares two medicines for the treatment of children born small and who stayed small:somapacitan (a new medicine) given once a week and Norditropin® (the medicine doctors can already prescribe) given once a day.“Investigational” means that the study medicine is currently being tested. It has not been approved by the U.S. Food and Drug Administration (FDA). Researchers will test somapacitan to see how well it works compared to the standard treatment for children born small and who stayed small. Researchers will also test if somapacitan is safe in children.


Clinical Study Identifier: s19-00509
ClinicalTrials.gov Identifier: NCT03878446
Principal Investigator: Paul Saenger
Currently Recruiting

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