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

May 7, 2026 updated by: Xiamen Amoytop Biotech Co., Ltd.

A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection, s.c Once a Week, Compared With Recombinant Human Growth Hormone (rhGH) Injection in Children With Short Stature Born Small for Gestational Age（SGA）

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

141

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
          • Di Wu
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Mingsheng Ma
      • Changchun, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Yining Zhang
      • Changsha, China
        • Recruiting
        • Hunan Children's Hospital
        • Contact:
          • Sha Zhao
      • Chengdu, China
        • Recruiting
        • West China Second University Hospital, Sichuan University
        • Contact:
          • Fan Yang
      • Chengdu, China
        • Recruiting
        • Chengdu Women's and Children's Central Hospital
        • Contact:
          • Xinran Cheng
      • Chongqing, China
        • Recruiting
        • Children's Hospital of Chongqing Medical University
        • Contact:
          • Min Zhu
      • Fuzhou, China
        • Recruiting
        • Fuzhou First General Hospital
        • Contact:
          • Yanqin Ying
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
          • Liyang Liang
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Qiuli Chen
      • Guangzhou, China
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Shunye Zhu
      • Guangzhou, China
        • Recruiting
        • Guangzhou Women and Children's Medical Center, Guangzhou Medical University
        • Contact:
          • Wen Zhang
      • Haikou, China
        • Recruiting
        • Hainan Women and Children's Medical Center
        • Contact:
          • Xiaoyan Huang
      • Hangzhou, China
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Chunlin Wang
      • Harbin, China
        • Recruiting
        • Heilongjiang Provincial Hospital
        • Contact:
          • Pu Zhao
      • Hefei, China
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
          • Deyun Liu
      • Hefei, China
        • Recruiting
        • Anhui Children's Hospital
        • Contact:
          • Yuqing Chen
      • Hohhot, China
        • Recruiting
        • Inner Mongolia People's Hospital
        • Contact:
          • Hua Zhu
      • Jinan, China
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Yan Sun
      • Jining, China
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Mei Zhang
      • Jiujiang, China
        • Recruiting
        • Jiujiang Maternal and Child Health Hospital
        • Contact:
          • Huayan Hu
      • Kunming, China
        • Recruiting
        • Kunming Children's Hospital
        • Contact:
          • Na Tao
      • Lanzhou, China
        • Recruiting
        • Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital)
        • Contact:
          • Bo Sun
      • Liuzhou, China
        • Recruiting
        • Liuzhou People's Hospital
        • Contact:
          • Ling Jin
      • Luoyang, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Dan Lou
      • Nanchang, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Yang Liu
      • Nanchang, China
        • Recruiting
        • Jiangxi Provincial Children's Hospital
        • Contact:
          • Yu Yang
      • Nanjing, China
        • Recruiting
        • Nanjing Children's Hospital
        • Contact:
          • Wei Gu
      • Ningbo, China
        • Recruiting
        • Ningbo Women and Children's Hospital, Ningbo University
        • Contact:
          • Shuxia Ding
      • Qujing, China
        • Recruiting
        • Qujing Maternal and Child Health Hospital
        • Contact:
          • Hongyan Zhu
      • Sanya, China
        • Recruiting
        • Sanya Central Hospital (Hainan Third People's Hospital)
        • Contact:
          • Hua Zhang
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Hospital
        • Contact:
          • Pin Li
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Lili Liang
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Guoying Chang
      • Shenyang, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Ying Xin
      • Suzhou, China
        • Recruiting
        • Children's Hospital of Soochow University
        • Contact:
          • Rongrong Xie
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Rongxiu Zheng
      • Wenzhou, China
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Xiaoou Shan
      • Wuhan, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, China
        • Recruiting
        • Wuhan Children's Hospital
        • Contact:
          • Hui Yao
      • Wuxi, China
        • Recruiting
        • Wuxi Children's Hospital
        • Contact:
          • Lulian Xu
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Qun Lian
      • Xiamen, China
        • Recruiting
        • Xiamen Maternal and Child Health Hospital
        • Contact:
          • Xiaoqing Yang
      • Xuzhou, China
        • Recruiting
        • Xuzhou Children's Hospital
        • Contact:
          • Ying Xue
      • Yuncheng, China
        • Recruiting
        • Yuncheng Central Hospital, Shanxi Province
        • Contact:
          • Yuenv Sun
      • Zhengzhou, China
        • Recruiting
        • Henan Children's Hospital (Zhengzhou Children's Hospital)
        • Contact:
          • Haiyan Wei
      • Zhuzhou, China
        • Recruiting
        • Zhuzhou Central Hospital
        • Contact:
          • Xianglan Wen
      • Ürümqi, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Maimaiti Mireguli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prepubertal (Tanner stage I) children: boys aged ≥2 and <11 years, and girls aged ≥2 and <10 years at screening.
  • Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
  • Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1.
  • Gestational age at birth ≥28 weeks.
  • Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2.
  • Body mass index (BMI) between the 5th and 95th percentiles for age and sex, according to the reference values in Appendix 3.
  • Peak GH level ≥10.0 ng/mL in at least one prior GH stimulation test.
  • No prior systemic growth-promoting therapy (used continuously for ≥1 month), including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc.
  • Legal guardian has provided written informed consent. If the participant is ≥8 years old, they must also provide written assent. For participants under 8 years old who are capable of expressing agreement, their assent should be formally documented.

Exclusion Criteria:

  • Subjects with closed epiphyses.
  • Subjects with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature due to GH receptor deficiency, short stature due to growth plate-related gene abnormalities (e.g., SHOX gene anomalies), growth retardation due to malnutrition, or growth retardation due to hypothyroidism.
  • Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening.
  • Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening.
  • Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin.
  • Abnormal liver or kidney function at screening (ALT > 1.5 times the upper limit of normal [ULN], Cr > ULN).
  • Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol/L prior to randomization.
  • Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B).
  • Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric/psychological disorders.
  • Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis.
  • History of intracranial hypertension.
  • Past or current history of malignant tumors, including intracranial tumors.
  • Known allergy to growth hormone or any of its excipients.
  • Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1
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.
Experimental: Experimental Group 2
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.
Active Comparator: rhGH group
Drug: Recombinant Human Growth Hormone Injection
Recombinant human growth hormone injection, 0.033mg/kg/day, s.c.,once daily, for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth velocity (HV, cm/year).
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in height standard deviation score from baseline (△HT SDS)
Time Frame: From baseline to all follow-up time points at Week 52
From baseline to all follow-up time points at Week 52
Change in growth velocity from baseline (△HV)
Time Frame: From baseline to all follow-up time points at Week 52
From baseline to all follow-up time points at Week 52
Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)
Time Frame: From baseline to all follow-up time points at Week 52
From baseline to all follow-up time points at Week 52
Ratio of the change in bone age to the change in chronological age
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Investigators

  • Principal Investigator: Xiaoping Luo, Ph.D, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 7, 2028

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGPESEN-4-2-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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