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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Growth velocity (HV, cm/year).
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Amoytop Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

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