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Weekly shot could replace daily needles for short kids

NCT ID NCT06927310

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new growth hormone medicine (inpegsomatropin) given once a week compared to the standard daily growth hormone shot. About 300 children with idiopathic short stature (short for no known medical reason) will receive either the weekly or daily injection for one year. The goal is to see if the weekly shot works as well and is safe.

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 300 people

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

Started

Apr 2025

Expected to finish

Jun 2028

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

3 to 11 years

Sex

Anyone

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 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.

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Conditions

The condition(s) this trial relates to.

isolated short stature

As listed by the trial registrant

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

Idiopathic short stature

How to take part

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

  1. The places running it

    38 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 Jining Medical University

    RECRUITING

    Jining, China

  • Anhui Provincial Children's Hospital

    RECRUITING

    Hefei, Anhui, China

  • Capital Institute of Pediatrics, Beijing (SHOUER)

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chengdu Women's and Children's Central Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • Children's Hospital Affiliated to Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • Children's Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Children's Hospital of Shanghai

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Gansu Provincial Maternity and Child Care Hospital

    RECRUITING

    Lanzhou, Gansu, China

  • Guangzhou Women and Children's Medical Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Hangzhou First People's Hospital

    RECRUITING

    Hangzhou, China

  • Henan Children's Hospital Zhengzhou Children's Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hunan Children's Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangxi Provincial Children's Hospital

    RECRUITING

    Nanchang, Jiangxi, China

  • Jiaxing First Hospital

    RECRUITING

    Jiaxing, China

  • Kunming Children's Hospital

    RECRUITING

    Kunming, China

  • Nanjing Children's Hospital

    RECRUITING

    Nanjing, China

  • Qingdao Women and Children's Hospital

    RECRUITING

    Qingdao, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, China

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Sanya Central Hospital

    RECRUITING

    Hainan, China

  • Shanghai Children's Medical Center

    RECRUITING

    Shanghai, China

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

    RECRUITING

    Guangzhou, Guangdong, China

  • The Affiliated Women's and Children's Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

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

    RECRUITING

    Henan, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Xinjiang, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, China

  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • West China Second University Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Wuhan Children's Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, China

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Yuncheng Central Hospital

    RECRUITING

    Yuncheng, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, China

  • Zhuzhou Central Hospital

    RECRUITING

    Zhuzhou, China

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Other studies related to the condition(s) this trial covers.