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New study aims to unlock growth secrets in short children

NCT ID NCT06309979

Knowledge-focused Sponsor: BioMarin Pharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study will follow 300 children with idiopathic short stature (ISS) — meaning they are shorter than expected for no known medical reason. Researchers will measure their height, weight, and other health factors over time to create a detailed picture of natural growth. The goal is to better understand ISS and identify any related health issues.

What this could mean

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

What this could lead to
If successful, this study could help doctors better understand how children with idiopathic short stature grow naturally, potentially guiding future treatment decisions.
What could go wrong
This is an observational study, so it does not test any treatment. It only collects data, so it cannot directly lead to new therapies. Results may not apply to all children with short stature.

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.

Participants

About 300 people

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

Started

Aug 2024

Expected to finish

Dec 2040

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.

Who is studied

The study population will include up to 600 pediatric individuals with Idiopathic Short Stature.

Ages

2 to 16 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. Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent. 2. A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm). 3. Participants who have either never received hGH, or who are currently receiving hGH treatment. 4. Historic stimulation test result with serum or plasma GH level greater than 10 μg/L. 5. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent. Exclusion Criteria: 1. Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor. 2. Known presence of one or more pituitary hormone deficiencies 3. Bone age advanced over chronological age by more than 3 years. 4. For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs). 5. For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs. 6. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ACGC Research, NYU Ambulatory Care Garden City

    RECRUITING

    Garden City, New York, 11530, United States

  • Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Center Of Excellence in Diabetes and Endocrinology

    RECRUITING

    Sacramento, California, 95821, United States

  • Centricity Research

    RECRUITING

    Columbus, Georgia, 31904, United States

  • Charleston Area Medical Center (CAMC) Health System

    WITHDRAWN

    Charleston, West Virginia, 25304, United States

  • Children's Hospital Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Orange County Main Campus - Orange

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Children's National Health System

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center Burnet Campus

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106-3322, United States

  • Cook Children's Endocrinology

    WITHDRAWN

    Fort Worth, Texas, 76104, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed)

    RECRUITING

    Los Angeles, California, 90502, United States

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - Pediatric Associates

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Medical College of Wisconsin, Children's Hospital

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Health System - Corporate Headquarters

    RECRUITING

    Pensacola, Florida, 32514, United States

  • New York University Grossman School of Medicine

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Ochsner Health Center for Children - New Orleans

    WITHDRAWN

    New Orleans, Louisiana, 70121, United States

  • Phoenix Children's Hospital - Thomas Campus (Main)

    WITHDRAWN

    Phoenix, Arizona, 85016, United States

  • Prisma Health Children's Hospital - Midlands

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Rady Children's Hospital - San Diego

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Rocky Mountain Clinical Research - Idaho Falls

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • Seattle Children's Hospital

    NOT_YET_RECRUITING

    Seattle, Washington, 98105, United States

  • St. Luke's Children's Endocrinology

    RECRUITING

    Boise, Idaho, 83712, United States

  • UBMD Pediatrics

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of California San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Iowa Stead Family Children's Hospital

    RECRUITING

    Princeton, New Jersey, 08540, United States

  • University of Louisville School Of Medicine - Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-4000, United States

  • University of Minnesota Medical School - Masonic Children's Hospital - Pediatric Specialty Care Explorer Clinic

    WITHDRAWN

    Minneapolis, Minnesota, 55454, United States

  • University of Texas Southwestern Medical Center

    WITHDRAWN

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232-2578, United States

  • WakeMed Children's - Pediatric Endocrinology - North Raleigh

    WITHDRAWN

    Raleigh, North Carolina, 27615, United States

  • Yale School of Medicine

    WITHDRAWN

    New Haven, Connecticut, 06511, United States

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