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

May 28, 2026 updated by: Xiamen Amoytop Biotech Co., Ltd.

Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection Versus Givopegsomatropin Solution Injection in the Treatment of Short Stature in Children With Turner Syndrome.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.
84

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
      • Anyang, China
        • Anyang Maternal and Child Health Hospital
        • Contact:
          • Huiping An
      • Beijing, China
        • Peking University First Hospital
        • Contact:
          • Yanling Yang
      • Beijing, China
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Hui Pan
      • Beijing, China
        • Beijing Children's hospital, Capital Medical University
        • Contact:
          • Di Wu
      • Beijing, China
        • Capital Institute of Pediatrics, Capital Medical University
        • Contact:
          • Bingyan Cao
      • Changsha, China
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Xingxing Zhang
      • Chengdu, China
        • Chengdu Women's and Children's Central Hospital
        • Contact:
          • Xinran Cheng
      • Chongqing, China
        • Children's Hospital of Chongqing Medical University
        • Contact:
          • Min Zhu
      • Dalian, China
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Luyi Ma
      • Guangzhou, China
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
          • Liyang Liang
      • Guangzhou, China
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, China
        • The Third Affiliated Hospital Of Sun Yat-Sen University
        • Contact:
          • Shunye Zhu
      • Guangzhou, China
        • Guangdong Provincial Maternal and Child Health Hospital
        • Contact:
          • Shu Liu
      • Hangzhou, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Chunlin Wang
      • Hangzhou, China
        • Zhejiang Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Lan Li
      • Hebei, China
        • The First Affiliated Hospital of Hebei North University
        • Contact:
          • Zhengrong Xu
      • Henan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Dan Lou
      • Huzhou, China
        • Huzhou Central Hospital
        • Contact:
          • Wei Qiu
      • Jiangxi, China
        • Jiangxi Provincial Children's Hospital
        • Contact:
          • Yu Yang
      • Jilin, China
        • The First Hospital of Jilin University
        • Contact:
          • Yining Zhang
      • Jinan, China
        • Shandong Provincial Hospital
        • Contact:
          • Yan Sun
      • Jining, China
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Mei Zhang
      • Kunming, China
        • Kunming Children's hospital
        • Contact:
          • Na Tao
      • Lanzhou, China
        • Gansu Provincial People's Hospital
        • Contact:
          • Juxiang Liu
      • Nanning, China
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Xin Fan
      • Pingxiang, China
        • Pingxiang People's Hospital
        • Contact:
          • Guangping Qin
      • Qilu, China
        • Qilu Hospital of Shandong University
        • Contact:
          • Aihua Cao
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Wenli Lu
      • Shanghai, China
        • Shanghai Children's Hospital
        • Contact:
          • Fei Wang
      • Shanghai, China
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Wenjuan Qiu
      • Shanghai, China
        • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Yu Ding
      • Shanxi, China
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
          • Haibo Lin
      • Shaoxing, China
        • Shaoxing People's Hospital
        • Contact:
          • Dihua Huang
      • Shenyang, China
        • Shengjing Hospital of China Medical University
        • Contact:
          • Ying Xin
      • Shenzhen, China
        • Shenzhen Children's Hospital
        • Contact:
          • Zhe Su
      • Sichuan, China
        • West China Second University Hospital, Sichuan University
        • Contact:
          • Jin Wu
      • Suzhou, China
        • Children's Hospital of Soochow University
        • Contact:
          • Fengyun Wang
      • Taizhou, China
        • Taizhou First People's Hospital
        • Contact:
          • Xiaoming Ying
      • Taizhou, China
        • Taizhou People's Hospital
        • Contact:
          • Shufang Yang
      • Tangshan, China
        • Tangshan Maternal and Child Health Hospital
        • Contact:
          • Lanying Wang
      • Wenzhou, China
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hong Zhu
      • Wuhan, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaoping Luo
      • Wuhan, China
        • Wuhan Children's Hospital
        • Contact:
          • Hui Yao
      • Wuxi, China
        • Affiliated Hospital of Jiangnan University
        • Contact:
          • Yaping Ma
      • Xi'an, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Erdi Xu
      • Xiamen, China
        • Xiamen Maternal and Child Health Hospital
        • Contact:
          • Xiaoqing Yang
      • Xiangyang, China
        • Xiangyang First People's Hospital
        • Contact:
          • Xi Yang
      • Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Mirigul Maimaiti
      • Yibin, China
        • Yibin Second People's Hospital
        • Contact:
          • Lan Yao
      • Zhengzhou, China
        • Henan Children's Hospital Zhengzhou Children's Hospital
        • Contact:
          • Haiyan Wei
      • Zibo, China
        • Zibo Central Hospital
        • Contact:
          • Xiaodong Zhao

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 girls at Tanner stage I, with age ≥ 2 years and < 12 years at the time of informed consent signature.
  • With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).
  • At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).
  • At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.
  • No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
  • Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks.
  • The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their assent shall be clearly documented.

Exclusion Criteria:

  • Subjects with closed epiphyses.
  • Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.
  • Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.
  • Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.
  • Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening.
  • Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc.
  • Abnormal liver and renal function at screening (ALT > 2 times the upper limit of normal; Cr > upper limit of normal).
  • Subjects with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol/L on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose tolerance judged by the investigator as unsuitable for participation in this study.
  • Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B.
  • Subjects with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders.
  • Subjects with severe congenital skeletal dysplasia; or those with scoliosis > 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis.
  • Subjects with a prior history of intracranial hypertension.
  • Subjects with a history of malignant tumor or current active malignant tumor, including intracranial tumors.
  • Known hypersensitivity to growth hormone or its excipients.
  • Subjects with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening.
  • Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.

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 Injection Group
Drug: Inpegsomatropin-Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Active Comparator: Givopegsomatropin Solution Injection Group
Drug: Givopegsomatropin Solution Injection
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, 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 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
Change in height 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
Ratio of change in bone age from baseline to change in chronological age from baseline (△BA/△CA)
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, 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 (Estimated)

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.
June 15, 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 30, 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.
February 28, 2030

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).
May 21, 2026

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.
May 21, 2026

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.
May 29, 2026

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.
June 2, 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 28, 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-4-2-004

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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