drugset / Trial / NCT04970654

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

NCT04970654

Phase 3 Completed 110 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.

Timeline

Start
2021-07-22
Primary completion
2023-11-17
Completion
2023-12-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Somatropin Protein / enzyme biologic 0.034 mg/kg Subcutaneous
Subject somapacitan Protein / enzyme biologic 0.16 mg/kg Subcutaneous

Indications