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

NCT07614152 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Turner Syndrome

Interventions

DRUG

Inpegsomatropin-Injection

Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.

DRUG

Givopegsomatropin Solution Injection

Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Sponsors & Collaborators

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoping Luo · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-03-30
Completion
2030-02-28

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 NCT07614152 on ClinicalTrials.gov