Actively Recruiting
Phase III Study of Weekly Inpegsomatropin Injection Compared to Daily Recombinant Human Growth Hormone for Treating Idiopathic Short Stature in Children Ages 3 to 11
Led by Xiamen Amoytop Biotech Co., Ltd. · Updated on 2026-03-11
300
Participants Needed
38
Research Sites
117 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Inpegsomatropin injection compared to recombinant human growth hormone rhGH in children with idiopathic short stature ISS. This multicenter, randomized, open-label Phase III trial aims to enroll 300 children with ISS, assessing growth outcomes and safety over a defined period. Participants will be randomly assigned to receive either Inpegsomatropin injection once weekly at 280 micrograms per kilogram or recombinant human growth hormone injection daily at 350 micrograms per kilogram divided into seven doses. The study includes a screening period of up to 12 weeks, followed by a 52-week treatment period and a 5-week post-treatment follow-up. During the trial, children will be monitored regularly for growth velocity, changes in height standard deviation scores, insulin-like growth factor 1 levels, and the ratio of bone age to chronological age. Safety evaluations will also be conducted throughout the study, with the total participation lasting approximately 69 weeks including all phases.
CONDITIONS
Brief Title
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
Research Team
X
Xiaoping Luo, Ph.D
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