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Weekly shot could replace daily growth hormone for short kids born small

NCT ID NCT07309562

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

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 once-weekly growth hormone injection (inpegsomatropin) against the standard daily growth hormone shot in 141 children born small for gestational age who remain short. The goal is to see if the weekly shot works as well or better at helping kids grow taller over one year. Participants will receive either the weekly injection or daily injections, and their growth, safety, and bone development will be tracked.

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 141 people

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

Started

Jan 2026

Expected to finish

May 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

2 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 (Tanner stage I) children: boys aged ≥2 and \<11 years, and girls aged ≥2 and \<10 years at screening. * Bone age is not more than 1 year advanced or more than 2 years delayed compared to chronological age (i.e., -2 years ≤ bone age - chronological age ≤ 1 year). * Birth weight and/or length below the 10th percentile for gestational age and sex, according to the reference values in Appendix 1. * Gestational age at birth ≥28 weeks. * Height at screening below -2 SD for age and sex, according to the reference values in Appendix 2. * Body mass index (BMI) between the 5th and 95th percentiles for age and sex, according to the reference values in Appendix 3. * Peak GH level ≥10.0 ng/mL in at least one prior GH stimulation test. * No prior systemic growth-promoting therapy (used continuously for ≥1 month), including but not limited to growth hormone, insulin-like growth factor-1 (IGF-1), etc. * Legal guardian has provided written informed consent. If the participant is ≥8 years old, they must also provide written assent. For participants under 8 years old who are capable of expressing agreement, their assent should be formally documented. Exclusion Criteria: * Subjects with closed epiphyses. * Subjects with other types of growth abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, short stature due to GH receptor deficiency, short stature due to growth plate-related gene abnormalities (e.g., SHOX gene anomalies), growth retardation due to malnutrition, or growth retardation due to hypothyroidism. * Participation in any other clinical trial with drug or non-drug interventions within 3 months prior to screening. * Use of inhaled corticosteroids for more than 2 consecutive weeks, or oral/intravenous corticosteroids for more than 1 consecutive week, within 3 months prior to screening. * Current or long-term requirement for therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, or insulin. * Abnormal liver or kidney function at screening (ALT \> 1.5 times the upper limit of normal \[ULN\], Cr \> ULN). * Diagnosis of diabetes mellitus, or two consecutive fasting blood glucose measurements ≥ 6.1 mmol/L prior to randomization. * Chronic infectious diseases which, in the investigator's judgment, may affect study participation (e.g., chronic hepatitis B). * Systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases, or psychiatric/psychological disorders. * Congenital skeletal dysplasia, scoliosis exceeding 15°, limping gait, or a prior diagnosis of slipped capital femoral epiphysis. * History of intracranial hypertension. * Past or current history of malignant tumors, including intracranial tumors. * Known allergy to growth hormone or any of its excipients. * Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction

As listed by the trial registrant

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

Small for gestational age

How to take part

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

  1. The places running it

    49 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 Children's Hospital

    RECRUITING

    Hefei, China

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Children's Hospital, 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

  • Fuzhou First General Hospital

    RECRUITING

    Fuzhou, China

  • Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital)

    RECRUITING

    Lanzhou, China

  • Guangzhou Women and Children's Medical Center, Guangzhou Medical University

    RECRUITING

    Guangzhou, China

  • Hainan Women and Children's Medical Center

    RECRUITING

    Haikou, China

  • Heilongjiang Provincial Hospital

    RECRUITING

    Harbin, China

  • Henan Children's Hospital (Zhengzhou Children's Hospital)

    RECRUITING

    Zhengzhou, China

  • Hunan Children's Hospital

    RECRUITING

    Changsha, China

  • Inner Mongolia People's Hospital

    RECRUITING

    Hohhot, China

  • Jiangxi Provincial Children's Hospital

    RECRUITING

    Nanchang, China

  • Jiujiang Maternal and Child Health Hospital

    RECRUITING

    Jiujiang, China

  • Kunming Children's Hospital

    RECRUITING

    Kunming, China

  • Liuzhou People's Hospital

    RECRUITING

    Liuzhou, China

  • Nanjing Children's Hospital

    RECRUITING

    Nanjing, China

  • Ningbo Women and Children's Hospital, Ningbo University

    RECRUITING

    Ningbo, China

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

    RECRUITING

    Beijing, China

  • Qujing Maternal and Child Health Hospital

    RECRUITING

    Qujing, China

  • Sanya Central Hospital (Hainan Third People's Hospital)

    RECRUITING

    Sanya, 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

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, China

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

    RECRUITING

    Guangzhou, China

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

    RECRUITING

    Luoyang, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, China

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

    RECRUITING

    Wuhan, China

  • West China Second University Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Wuhan Children's Hospital

    RECRUITING

    Wuhan, China

  • Wuxi Children's Hospital

    RECRUITING

    Wuxi, China

  • Xiamen Maternal and Child Health Hospital

    RECRUITING

    Xiamen, China

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Xuzhou Children's Hospital

    RECRUITING

    Xuzhou, China

  • Yuncheng Central Hospital, Shanxi Province

    RECRUITING

    Yuncheng, China

  • Zhuzhou Central Hospital

    RECRUITING

    Zhuzhou, China

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