Clinical Trial

The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature

Recruiting Phase 3
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Summary
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-04-13; most recent amendment 2026-03-10.
Status change: Not Yet Recruiting → Recruiting 2025-07-09
Trial Details
NCT Number NCT06927310
Lead Sponsor Xiamen Amoytop Biotech Co., Ltd.
Collaborators: Tongji Hospital
Conditions Idiopathic Short Stature
Enrollment 300 participants
Start Date 2025-04-28
Primary Completion 2026-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-11