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Weekly shot could replace daily needles for short stature kids

NCT ID NCT07226089

Disease control Sponsor: Rabin Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if a once-weekly injection of somatrogon works as well as a daily growth hormone shot for children with short stature. It includes 254 children born small for their age or with no clear cause for their short height. The goal is to see if the weekly option can improve height just as much, with fewer injections.

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 254 people

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

Started

Feb 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Diagnosis of SGA or ISS. SGA, defined as born with a birth weight and/or length \<-2 SDS below the mean for gestational age. ISS, defined as height \< -2 SDS for age and gender without evidence of GHD 2. Females aged ≥3 years and \<9 years. Males aged ≥3 years and \<11 years 3. Pre-pubertal- Tanner stage 1 for breasts and testes. 4. A bone age of not more than chronological age recorded in previous 8 weeks. 5. Current height \< -2 SDS for age and gender. 6. Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening 7. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of cancer, radiation therapy or chemotherapy. 2. History of GHD. 3. Children who are small due to malnutrition, defined as a Z score of weight for height and/or BMI below -2 for age, according to national standards. 4. History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis. 5. Microcephaly (Head Circumference \< -2 SDS) 6. Any chronic disease or diagnosis, likely to affect growth, including but not limited to gastrointestinal disorder, celiac disease, untreated thyroid disease, diabetes mellitus and metabolic disorders. 7. Known or suspected skeletal dysplasias 8. Known or suspected chromosomal abnormalities 9. IGF-1 \>2 SDS 10. Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol 11. Prior exposure to growth promoting therapy 12. Current use of any prohibited concomitant medication(s): Any rhGH or growth-promoting therapy, Any therapy that affects appetite or weight, Psychiatric medications associated with weight changes and/or diabetes, excluding medications used to treat ADHD, Any androgen or estrogen therapy including over the counter supplements, Systemic corticosteroids (inhaled or oral) exceeding the doses: Inhaled: \> 400 μg/day of inhaled budesonide or equivalent. Oral: \> 8 mg/m2/day of oral hydrocortisone or equivalent. 13. Previous administration with an investigational drug within 90 days. 14. Fasting blood glucose \>126 mg/dL 15. Renal impairment 16. Hepatic dysfunction. 17. Pregnancy 18. Known hypersensitivity to the components of the study intervention

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Conditions

The condition(s) this trial relates to.

fetal growth restriction isolated short stature SHOX-related short stature

As listed by the trial registrant

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

ISS SGA

How to take part

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

  1. The places running it

    32 sites in 5 countries. 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

  • All India Institute of Medical Sciences (AIIMS) - New Delhi

    NOT_YET_RECRUITING

    New Delhi, India

  • Apollo Hospitals Enterprise Limited

    NOT_YET_RECRUITING

    Navi Mumbai, India

  • Assaf Harofe Medical Center

    NOT_YET_RECRUITING

    Rishon LeZiyyon, Israel

  • Atlantic Health System

    NOT_YET_RECRUITING

    Morristown, New Jersey, 07901, United States

  • CHU Hôpital de la Timone

    NOT_YET_RECRUITING

    Marseille, France

  • Centre Hospitalier Universitaire d'Angers

    NOT_YET_RECRUITING

    Angers, France

  • Children's Minnesota - Minneapolis

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Chu de Lyon - Hopital Femme Mere Enfant

    NOT_YET_RECRUITING

    Lyon, France

  • Cook Children's Medical Center

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76104, United States

  • Dana-Duek children's hospital

    NOT_YET_RECRUITING

    Tel Aviv, Israel

  • Dell Children's Medical Group

    NOT_YET_RECRUITING

    Austin, Texas, 78723, United States

  • Hackensack University Medical Center

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hassenfeld Children's Hospital at NYU Langone

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Hôpital Armand-Trousseau

    NOT_YET_RECRUITING

    Paris, France

  • Hôpital Bicêtre

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, France

  • Hôpital Necker - Enfants Malades

    NOT_YET_RECRUITING

    Paris, France

  • Jehangir Hospital

    NOT_YET_RECRUITING

    Maheshra, India

  • Nara Prefecture General Medical Center

    NOT_YET_RECRUITING

    Nara, Japan

  • National Center for Child Health and Development

    NOT_YET_RECRUITING

    Setagaya-Ku, Japan

  • Nemours Children's Clinic - Jacksonville

    NOT_YET_RECRUITING

    Jacksonville, Florida, 19803, United States

  • Osaka City General Hospital

    NOT_YET_RECRUITING

    Osaka, Japan

  • Osaka Women's and Children's Hospital

    NOT_YET_RECRUITING

    Izumi-Shi, Japan

  • Rocky Mountain Pediatric Endocrinology

    NOT_YET_RECRUITING

    Centennial, Colorado, 3433325, United States

  • Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey

    NOT_YET_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Schneider Children Medical Center- the institute of Endocrinology and Diabetes

    RECRUITING

    Petah Tikva, Israel, 4920235, Israel

  • Shaare Zedek Medical Center

    NOT_YET_RECRUITING

    Jerusalem, Israe, 9103102, Israel

  • Sheba Medical Center

    NOT_YET_RECRUITING

    Ramat Gan, Israel

  • Sir Ganga Ram Hospital

    NOT_YET_RECRUITING

    New Delhi, India

  • Soroka hospital

    NOT_YET_RECRUITING

    Bear Sheva, Israel

  • The State University of New York (SUNY) School of Medicine and Biomedical Sciences

    NOT_YET_RECRUITING

    Buffalo, New York, 13210, United States

  • The University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of California Los Angeles (UCLA) - Mattel Children's Hospital

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

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