Sonrai

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature who were either born small for gestational age (SGA) or have idiopathic short stature (ISS). This is a Phase 3 randomized, open-label study that plans to enroll two groups of children: 140 with SGA and 114 with ISS, all of whom have not received prior growth hormone treatment. The study duration is 12 months, with an initial screening period of up to 30 days. Participants will be randomly assigned to receive either Somatrogon once weekly or Genotropin daily for 12 months. The study involves two parallel groups: one group for children with SGA and another for children with ISS, each split evenly between the two treatment options. The treatments are administered as growth hormone injections either weekly or daily, and the study monitors their effects over a full year. Throughout the study, children will have regular visits to monitor growth, including measuring annualized height velocity after 12 months of treatment. Assessments will include growth measurements and evaluations of safety and treatment adherence. Researchers will collect data to compare the outcomes and safety profiles of the two growth hormone regimens over the study period, supporting ongoing treatment decisions for children with short stature related to SGA or ISS.