Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-05-07

Target enrollment:

Participant gender:

Summary

This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injectiononce a weekcompared 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.

Phase:

PHASE3

Details

Lead Sponsor:

Xiamen Amoytop Biotech Co., Ltd.

Treatments:

Growth Hormone