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Turner SyndromePhase 3NCT07614152

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

A Phase 3 study testing Inpegsomatropin-Injection and Givopegsomatropin Solution Injection in people with Turner Syndrome, run by Xiamen Amoytop Biotech Co., Ltd. at 51 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 12 years, women only
Conditions the study is for
Turner Syndrome
What is being tested?
Inpegsomatropin-Injection and Givopegsomatropin Solution Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
51 sitesChina
Study dates
5 Jul 2026to 28 Feb 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

51 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoping Luo contact

15671671188

xpluo@tjh.tjmu.edu.cn

51 sites in 1 country

China51 sites, 51 recruiting

  • Anyang Maternal and Child Health Hospital

    Anyang

    Huiping An

    Recruiting

  • Beijing Children's Hospital, Capital Medical University

    Beijing

    Di Wu

    Recruiting

  • Capital Institute of Pediatrics, Capital Medical University

    Beijing

    Bingyan Cao

    Recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing

    Hui Pan

    Recruiting

  • Peking University First Hospital

    Beijing

    Yanling Yang

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Xingxing Zhang

    Recruiting

  • Chengdu Women's and Children's Central Hospital

    Chengdu

    Xinran Cheng

    Recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing

    Min Zhu

    Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

    Luyi Ma

    Recruiting

  • Guangdong Provincial Maternal and Child Health Hospital

    Guangzhou

    Shu Liu

    Not yet recruiting

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

    Guangzhou

    Liyang Liang

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Qiuli Chen

    Recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Shunye Zhu

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Chunlin Wang

    Recruiting

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Hangzhou

    Lan Li

    Recruiting

  • The First Affiliated Hospital of Hebei North University

    Hebei

    Zhengrong Xu

    Recruiting

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

    Henan

    Dan Lou

    Recruiting

  • Huzhou Central Hospital

    Huzhou

    Wei Qiu

    Recruiting

  • Jiangxi Provincial Children's Hospital

    Jiangxi

    Yu Yang

    Recruiting

  • The First Hospital of Jilin University

    Jilin City

    Yining Zhang

    Recruiting

  • Shandong Provincial Hospital

    Jinan

    Yan Sun

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining

    Mei Zhang

    Recruiting

  • Kunming Children's Hospital

    Kunming

    Na Tao

    Recruiting

  • Gansu Provincial People's Hospital

    Lanzhou

    Juxiang Liu

    Recruiting

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning

    Xin Fan

    Recruiting

  • Pingxiang People's Hospital

    Pingxiang

    Guangping Qin

    Recruiting

  • Qilu Hospital of Shandong University

    Qilu

    Aihua Cao

    Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Wenli Lu

    Recruiting

  • Shanghai Children's Hospital

    Shanghai

    Fei Wang

    Recruiting

  • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Yu Ding

    Recruiting

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

    Wenjuan Qiu

    Recruiting

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Shanxi

    Haibo Lin

    Recruiting

  • Shaoxing People's Hospital

    Shaoxing

    Dihua Huang

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Ying Xin

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen

    Zhe Su

    Recruiting

  • West China Second University Hospital, Sichuan University

    Sichuan

    Jin Wu

    Recruiting

  • Children's Hospital of Soochow University

    Suzhou

    Fengyun Wang

    Recruiting

  • Taizhou First People's Hospital

    Taizhou

    Xiaoming Ying

    Recruiting

  • Taizhou People's Hospital

    Taizhou

    Shufang Yang

    Recruiting

  • Tangshan Maternal and Child Health Hospital

    Tangshan

    Lanying Wang

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Hong Zhu

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Xiaoping Luo

    Recruiting

  • Wuhan Children's Hospital

    Wuhan

    Hui Yao

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi

    Yaping Ma

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Erdi Xu

    Recruiting

  • Xiamen Maternal and Child Health Hospital

    Xiamen

    Xiaoqing Yang

    Not yet recruiting

  • Xiangyang First People's Hospital

    Xiangyang

    Xi Yang

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang

    Mirigul Maimaiti

    Recruiting

  • Yibin Second People's Hospital

    Yibin

    Lan Yao

    Recruiting

  • Henan Children's Hospital Zhengzhou Children's Hospital

    Zhengzhou

    Haiyan Wei

    Recruiting

  • Zibo Central Hospital

    Zibo

    Xiaodong Zhao

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Turner Syndrome
Being tested
Inpegsomatropin-Injection, Givopegsomatropin Solution Injection
Keywords
Inpegsomatropin Injection, Givopegsomatropin Solution Injection
Medical subject headings
Turner Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inpegsomatropin-InjectionDrug

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

  • Givopegsomatropin Solution InjectionDrug

    Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Study groups in NCT07614152
Study groupRoleWhat they receive
Inpegsomatropin Injection GroupExperimentalNot described
Receives: Drug: Inpegsomatropin-Injection
Givopegsomatropin Solution Injection GroupActive comparatorNot described
Receives: Drug: Givopegsomatropin Solution Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth velocity (HV, cm/year).

    Measured: Week 52

Secondary outcomes (4)

  1. Change in height standard deviation score from baseline (△HT SDS)

    Measured: From baseline to all follow-up time points at Week 52

  2. Change in height velocity from baseline (△HV)

    Measured: From baseline to all follow-up time points at Week 52

  3. Change in insulin-like growth factor 1 standard deviation score from baseline (△IGF-1 SDS)

    Measured: From baseline to all follow-up time points at Week 52

  4. Ratio of change in bone age from baseline to change in chronological age from baseline (△BA/△CA)

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start5 Jul 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614152
Sponsor's protocol ID
PEGPESEN-4-2-004
Status last verified
Jul 2026
First submitted
21 May 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inpegsomatropin-Injection and Givopegsomatropin Solution Injection in people with Turner Syndrome, run by Xiamen Amoytop Biotech Co., Ltd. at 51 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoping Luo (15671671188, xpluo@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth velocity (HV, cm/year). (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07614152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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