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Weekly shot could replace daily growth hormone injections for children

NCT ID NCT03305016

Disease control Sponsor: Ascendis Pharma Endocrinology Division A/S 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 3 trial tests a long-acting growth hormone called TransCon hGH, given as a once-weekly injection, in about 150 children with growth hormone deficiency. The study aims to see if the weekly shot is safe and helps children grow at a normal rate. All participants receive the drug, and the trial lasts 26 weeks.

What this could mean

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

Active substance
TransCon hGH (a long-acting growth hormone injection)
What this could lead to
If successful, this could offer children with growth hormone deficiency a more convenient once-weekly injection instead of daily shots, potentially improving adherence and quality of life.
What could go wrong
This is a phase 3 trial, but it is open-label (everyone knows they get the drug) and relatively short (26 weeks). Long-term safety and effectiveness are not yet established, and individual results may vary.

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

146 people

The number who actually took part.

Started

Nov 2017

Finished

Mar 2019

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

6 months to 17 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. Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy. 2. 6 months to 17 years old, inclusive, at Visit 1 1. If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1 2. If ≥ 6 months but \< 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1 3. Tanner stage \< 5 at Visit 1 4. Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males) 5. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC Exclusion Criteria: 1. Weight of \< 5.5 kg or \> 80 kg at Visit 1 2. Females of child-bearing potential 3. History of malignant disease 4. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism) 5. Poorly-controlled diabetes mellitus (HbA1c \>8.0%) or diabetic complications 6. Known neutralizing antibodies against hGH 7. Major medical conditions, unless approved by Medical Monitor 8. Pregnancy 9. Presence of contraindications to hGH treatment 10. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver) 11. Participation in any other trial of an investigational agent within 30 days prior to Visit 1 12. Prior exposure to investigational hGH

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Conditions

The condition(s) this trial relates to.

endocrine system disorder Failure to Thrive isolated congenital growth hormone deficiency pituitary dwarfism pituitary gland disorder

As listed by the trial registrant

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

Endocrine system diseases Growth hormone deficiency, pediatric Hormone deficiency Pituitary diseases

Contacts and locations

Locations

  • Center of Excellence in Diabetes and Endocrinology

    Sacramento, California, 95821, United States

  • Children's Diabetes and Endocrine Center

    Portland, Oregon, 97227, United States

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507, United States

  • Children's Medical Center

    Dallas, Texas, 75235, United States

  • Children's Minnesota

    Saint Paul, Minnesota, 55102, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Monash Children's Hospital

    Clayton, Victoria, 3168, Australia

  • NYU Winthrop Hospital

    Mineola, New York, 11501, United States

  • Nemours Children's Health System

    Jacksonville, Florida, 32207, United States

  • Neufeld Medical Group Inc.

    Los Angeles, California, 90048, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Orlando Health Inc.

    Orlando, Florida, 32806, United States

  • Rocky Mountain Pediatric Endocrinology

    Centennial, Colorado, 80112, United States

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • The Liggins Institute, The University of Auckland

    Grafton, Auckland, 1023, New Zealand

  • University of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Children's Hospital

    Charlottesville, Virginia, 22903, United States

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