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

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.

NCT Number	NCT07309562
Lead Sponsor	Xiamen Amoytop Biotech Co., Ltd.
Conditions	Small for Gestational Age
Enrollment	141 participants
Start Date	2026-01-20
Primary Completion	2028-03 (estimated)
Study Completion	2028-05-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-08