The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

April 28, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2028

Conditions
Idiopathic Short Stature
Interventions
DRUG

Inpegsomatropin Injection

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

DRUG

Recombinant Human Growth Hormone Injection

Recombinant Human Growth Hormone Injection, 350 μg/kg/week, s.c., divided into 7 doses, i.e., 50 μg/kg/day (0.15 IU/kg/day), once daily for 52 consecutive weeks.

Trial Locations (24)

Unknown

RECRUITING

Anhui Provincial Children's Hospital, Hefei

RECRUITING

The Second Affiliated Hospital of Anhui Medical University, Hefei

RECRUITING

Capital Institute of Pediatrics, Beijing (SHOUER), Beijing

RECRUITING

Children's Hospital of Chongqing Medical University, Chongqing

RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

RECRUITING

Gansu Provincial Maternity and Child Care Hospital, Lanzhou

RECRUITING

Guangzhou Women and Children's Medical Center, Guangzhou

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

RECRUITING

The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou

RECRUITING

Henan Children's Hospital Zhengzhou Children's Hospital, Zhengzhou

RECRUITING

Wuhan Children's Hospital, Wuhan

RECRUITING

Hunan Children's Hospital, Changsha

RECRUITING

Children's Hospital Affiliated to Soochow University, Suzhou

RECRUITING

Jiangxi Provincial Children's Hospital, Nanchang

RECRUITING

Children's Hospital of Shanghai, Shanghai

RECRUITING

Chengdu Women's and Children's Central Hospital, Chengdu

RECRUITING

West China Second University Hospital, Sichuan University, Chengdu

RECRUITING

The Affiliated Women's and Children's Hospital of Ningbo University, Ningbo

RECRUITING

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou

RECRUITING

Sanya Central Hospital, Hainan

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology, Henan

RECRUITING

Affiliated Hospital of Jining Medical University, Jining

RECRUITING

Kunming Children's Hospital, Kunming

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University, Xinjiang

All Listed Sponsors
collaborator

Tongji Hospital

OTHER

lead

Xiamen Amoytop Biotech Co., Ltd.

INDUSTRY