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

NCT07309562 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoping Luo, Ph.D · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2028-03-31
Completion
2028-05-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309562 on ClinicalTrials.gov