The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.

NCT Number	NCT07614152
Lead Sponsor	Xiamen Amoytop Biotech Co., Ltd.
Conditions	Turner Syndrome
Enrollment	84 participants
Start Date	2026-07-05
Primary Completion	2028-03-30 (estimated)
Study Completion	2030-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-07-22