NCT07309562

The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age

A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection, s.c Once a Week, Compared With Recombinant Human Growth Hormone (rhGH) Injection in Children With Short Stature Born Small for Gestational Age（SGA）

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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 short stature born small for gestational age (SGA).It plans to enroll 141 children with short stature born small for gestational age (SGA), who will be stratified by gender and age and randomized in a 1:1:1 ratio to either Experimental Group 1, Experimental Group 2, or the Active Control Group. All participants will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). Safety and efficacy will be comprehensively evaluated.

Conditions

• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	Inpegsomatropin Injection	Inpegsomatropin injection, 140 μg/kg/week, s.c., once weekly, for 52 weeks.
DRUG	Inpegsomatropin Injection	Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
DRUG	Recombinant Human Growth Hormone Injection	Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.

Timeline

• Start date: 2026-01-20
• Primary completion: 2028-03-01
• Completion: 2028-05-07
• First posted: 2025-12-30
• Last updated: 2026-03-02

Locations

48 sites across 1 country: China