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New weekly shot could help girls with turner syndrome grow taller

NCT ID NCT07614152

Disease control Sponsor: Xiamen Amoytop Biotech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This phase 3 study tests a new weekly growth hormone injection (inpegsomatropin) against an existing one (givopegsomatropin) in 84 girls with Turner syndrome who have short stature. The goal is to see which works better for increasing growth over 52 weeks. Participants are prepubertal girls aged 2 to 12 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inpegsomatropin (a long-acting growth hormone injection)
What this could lead to
If it works, this could offer a new weekly growth hormone option for girls with Turner syndrome, potentially improving height outcomes.
What could go wrong
This is a phase 3 trial, but it's not yet recruiting and has only 84 participants. The drug may not prove superior to the existing treatment, and side effects like injection site reactions or hormone imbalances are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 12 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Turner syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Turner syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Jiangnan University

    RECRUITING

    Wuxi, China

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, China

  • Anyang Maternal and Child Health Hospital

    RECRUITING

    Anyang, China

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Capital Institute of Pediatrics, Capital Medical University

    RECRUITING

    Beijing, China

  • Chengdu Women's and Children's Central Hospital

    RECRUITING

    Chengdu, China

  • Children's Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, China

  • Children's Hospital of Soochow University

    RECRUITING

    Suzhou, China

  • Gansu Provincial People's Hospital

    RECRUITING

    Lanzhou, China

  • Guangdong Provincial Maternal and Child Health Hospital

    NOT_YET_RECRUITING

    Guangzhou, China

  • Henan Children's Hospital Zhengzhou Children's Hospital

    RECRUITING

    Zhengzhou, China

  • Huzhou Central Hospital

    RECRUITING

    Huzhou, China

  • Jiangxi Provincial Children's Hospital

    RECRUITING

    Jiangxi, China

  • Kunming Children's Hospital

    RECRUITING

    Kunming, China

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

    RECRUITING

    Beijing, China

  • Peking University First Hospital

    RECRUITING

    Beijing, China

  • Pingxiang People's Hospital

    RECRUITING

    Pingxiang, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Qilu, China

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, China

  • Shanghai Children's Hospital

    RECRUITING

    Shanghai, China

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

    RECRUITING

    Shanghai, China

  • Shaoxing People's Hospital

    RECRUITING

    Shaoxing, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, China

  • Shenzhen Children's Hospital

    RECRUITING

    Shenzhen, China

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

    RECRUITING

    Guangzhou, China

  • Taizhou First People's Hospital

    RECRUITING

    Taizhou, China

  • Taizhou People's Hospital

    RECRUITING

    Taizhou, China

  • Tangshan Maternal and Child Health Hospital

    RECRUITING

    Tangshan, China

  • The First Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, China

  • The First Affiliated Hospital of Hebei North University

    RECRUITING

    Hebei, China

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

    RECRUITING

    Henan, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Xinjiang, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The First Hospital of Jilin University

    RECRUITING

    Jilin City, China

  • The Second Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, China

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    RECRUITING

    Shanxi, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, China

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

    RECRUITING

    Wuhan, China

  • West China Second University Hospital, Sichuan University

    RECRUITING

    Sichuan, China

  • Wuhan Children's Hospital

    RECRUITING

    Wuhan, China

  • Xiamen Maternal and Child Health Hospital

    NOT_YET_RECRUITING

    Xiamen, China

  • Xiangyang First People's Hospital

    RECRUITING

    Xiangyang, China

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Yibin Second People's Hospital

    RECRUITING

    Yibin, China

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    RECRUITING

    Hangzhou, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, China

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