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Can daily growth hormone shots help short kids catch up?

NCT ID NCT07815626

Symptom relief Sponsor: Zhongshan Sansure Hygene Biomedicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing a human growth hormone injection called Sinotropin AQ in children with idiopathic short stature, a condition where kids are shorter than expected for their age without a known cause. The trial enrolls 240 prepubertal children and randomly assigns them to receive either the study hormone or an active comparator for 52 weeks. The main goal is to see how much the children grow in a year, measured as height velocity, and whether the treatment is safe.

What this could mean

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

Active substance
human growth hormone injection
What this could lead to
If it works, this could give families another approved option for helping children with idiopathic short stature grow taller.
What could go wrong
The trial may show the new growth hormone is not as effective as the comparator, or that any height gain is small. Daily injections for a year can be burdensome, and growth hormone carries risks like fluid retention and joint pain.

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 240 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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: * 1\. Tanner stage I (prepubertal) at informed consent: males aged 3 to \<11 years ; females aged 3 to \<10 years ; * 2\. At screening, height \< -2 standard deviations (SD) for age and sex (height reference per Appendix 1); * 3\. Peak GH ≥10.0 ng/mL in any growth hormone (GH) stimulation test; * 4\. Bone age minus chronological age ≤ 1 year. Exclusion Criteria: * 1.Closed epiphyses (skeletally mature)； * 2.Severe allergic diathesis, or known hypersensitivity to growth hormone or any of its excipients； * 3.History of malignancy or current active malignancy； * 4.Systemic chronic diseases, including but not limited to moderate-to-severe anemia, hypothyroidism, chronic kidney disease, cardiovascular disease (e.g., dilated cardiomyopathy), psychiatric disorders, or congenital anomalies that require clinical intervention per the investigator's judgment. * 5.Patients with a prior diagnosis of intracranial hypertension; * 6.Patients with congenital skeletal dysplasia, or scoliosis ≥15° (or moderate or greater), limping (gait disturbance), and patients with a prior diagnosis of slipped capital femoral epiphysis ; * 7.Other types of growth and developmental disorders, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age (SGA), short stature due to SHOX gene defects, and short stature of other identified causes; * 8\. Patients with a confirmed diagnosis of diabetes mellitus, or fasting blood glucose ≥6.1 mmol/L on two consecutive measurements.

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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 (ISS)

How to take part

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

  1. The places running it

    34 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

  • Anhui Provincial Children's Hospital

    Hefei, Anhui, China

  • Capital Center for Children's Health, Captical Medical University

    Beijing, Beijing Municipality, China

  • Changsha Hospital for Maternal and Child Health Care

    Changsha, Hunan, China

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, China

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu, China

  • Guangdong Hospital for Materal and Child Health Care

    Guangzhou, Guangdong, China

  • Hunan Children's Hospital

    Changsha, Hunan, China

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, China

  • Kunming Children's Hospital

    Kunming, Yunnan, China

  • Qingdao Women and Children's Hospital

    Qingdao, Shandong, China

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

    Shanghai, Shanghai Municipality, China

  • Shandong Provincial Hospital

    Jinan, Shandong, China

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality, China

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

    Shanghai, Shanghai Municipality, China

  • Shanxi Children's Hospital

    Taiyuan, Shanxi, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China

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

    Guangzhou, Guangdong, China

  • Tangshan Maternal and Child Health Hospital

    Tangshan, Hebei, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, China

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

    Wuhan, Hubei, China

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, China

  • Women and Children's Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • Wuhan Children's Hospital

    Wuhan, Hubei, China

  • Wuxi Children's Hospital

    Wuxi, Jiangsu, China

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

    Shanghai, Shanghai Municipality, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China