Study Comparing Weekly Somatrogon to Daily Genotropin for Treating Short Stature in Children Born Small for Gestational Age or With Idiopathic Short Stature

What this Trial Is About

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone Genotropin for treating children born Small for Gestational Age SGA or with Idiopathic Short Stature ISS. This randomized, open-label study involves pre-pubertal children who have not previously received growth hormone treatment. The study is planned to last 12 months, including a screening period of up to 30 days, and aims to measure growth outcomes in these children. The study includes two groups one with 140 children with SGA and another with 114 children with ISS. Both groups will be randomly assigned to receive either Somatrogon once weekly via a subcutaneous disposable prefilled pen or Genotropin daily subcutaneous injections using commercial growth hormone delivery devices. Treatment will continue for 12 months for all participants. Participants will be involved in regular visits to assess growth through measurements such as annual height velocity, height standard deviation scores, bone maturation, and levels of Insulin-like Growth Factor-1 IGF-1. Quality of life related to health will also be evaluated before and after treatment. Monitoring includes laboratory tests and maintaining stable hormone levels. The total participation duration includes the screening and 12 months of treatment, with assessments at multiple time points throughout the study.

Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.