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

March 10, 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 Idiopathic Short Stature (ISS).

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 idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be 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.
300

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
      • Hainan, China
        • Recruiting
        • Sanya Central Hospital
        • Contact:
          • Hua Zhang
      • Hangzhou, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Xiaoming Luo
      • Hangzhou, China
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
          • Chunming Jiang
      • Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Dan Lou
      • Jiaxing, China
        • Recruiting
        • Jiaxing First Hospital
        • Contact:
          • Shunfeng Mao
      • Jining, China
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Meiyun Xin
      • Kunming, China
        • Recruiting
        • Kunming Children's Hospital
        • Contact:
          • Na Tao
      • Nanjing, China
        • Recruiting
        • Nanjing Children's Hospital
        • Contact:
          • Wei Gu
      • Qingdao, China
        • Recruiting
        • Qingdao Women and Children's Hospital
        • Contact:
          • Tang Li
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:
          • Xiumin Wang
        • Contact:
          • Yu Ding
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Huiwen Zhang
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Wenli Lu
      • Shijiazhuang, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Huijuan Ma
      • Wuhan, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Jingping Ye
      • Xi'an, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Erdi Xu
      • Xiangyang, China
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
          • Rui Pan
      • Xinjiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Miregul Mamat
      • Yuncheng, China
        • Recruiting
        • Yuncheng Central Hospital
        • Contact:
          • Sufang Chang
      • Zhuzhou, China
        • Recruiting
        • Zhuzhou Central Hospital
        • Contact:
          • Xianglan Wen
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Children's Hospital
        • Contact:
          • Yuqing Chen
      • Hefei, Anhui, China
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
          • Deyun Liu
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Capital Institute of Pediatrics, Beijing (SHOUER)
        • Contact:
          • Fuying Song
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Children's Hospital of Chongqing Medical University
        • Contact:
          • Min Zhu
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Qun Lian
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • Gansu Provincial Maternity and Child Care Hospital
        • Contact:
          • Bo Sun
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
          • Liyang Liang
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
          • Wen Zhang
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Third Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Shunye Zhu
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Children's Hospital Zhengzhou Children's Hospital
        • Contact:
          • Haiyan Wei
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Wuhan Children's Hospital
        • Contact:
          • Hui Yao
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Children's Hospital
        • Contact:
          • Yan Zhong
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • Children's Hospital Affiliated to Soochow University
        • Contact:
          • Haiying Wu
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Provincial Children's Hospital
        • Contact:
          • Yu Yang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Children's Hospital of Shanghai
        • Contact:
          • Pin Li
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Chengdu Women's and Children's Central Hospital
        • Contact:
          • Xinran Cheng
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Second University Hospital, Sichuan University
        • Contact:
          • Fan Yang
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • The Affiliated Women's and Children's Hospital of Ningbo University
        • Contact:
          • Shuxia Ding
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:
          • Xiaoou Shan

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 children: boys aged ≥3 years and <11 years at screening with testicular volume <4 mL; girls aged ≥3 years and <10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue.
  • Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).
  • Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1.
  • Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2.
  • Peak GH level ≥10.0 ng/ml in at least one GH stimulation test.
  • No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
  • The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented.

Exclusion Criteria:

  • Individuals with closed epiphyses;
  • Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities;
  • Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions;
  • Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening;
  • Individuals who are currently receiving or require long-term treatment with other therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, insulin, etc.;
  • Individuals with abnormal liver or kidney function at screening (ALT > 1.5 times the upper limit of normal, Cr > upper limit of normal);
  • Individuals diagnosed with diabetes mellitus, or with fasting blood glucose ≥6.1 mmol/L on two consecutive occasions;
  • Individuals with chronic infectious diseases, such as chronic hepatitis B;
  • Individuals with systemic chronic diseases, such as moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., dilated cardiomyopathy, etc.), psychiatric and psychological disorders, or those with congenital anomalies requiring clinical intervention as determined by the investigator;
  • Individuals with congenital skeletal abnormalities, or those with scoliosis exceeding 15°, limping, or a history of slipped capital femoral epiphysis;
  • Individuals with a history of increased intracranial pressure;
  • Individuals with a history of malignancy or currently having active malignancy, including intracranial tumors;
  • Individuals with severe allergic constitutions, or known allergies to growth hormone or its excipients;
  • Individuals with any other disease that the investigator deems may endanger the subject's safety or compromise compliance with the study protocol.

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: Inpegsomatropin group
Drug: Inpegsomatropin Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 consecutive weeks.
Active Comparator: rhGH group
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.

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
The ratio of the change in bone age to the change in chronological age (△BA/△CA)
Time Frame: From baseline to all follow-up time points at Week 52
From baseline to all follow-up time points at 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.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tongji Hospital

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.
April 28, 2025

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, 2026

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.
June 1, 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).
April 6, 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.
April 13, 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.
April 15, 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.
March 11, 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.
March 10, 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.
March 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-4-2-001

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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