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Weekly shot could replace daily needles for kids with growth hormone deficiency

NCT ID NCT03344458

Disease control Sponsor: Ascendis Pharma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a long-acting growth hormone called TransCon hGH, given as a once-weekly injection, in children with growth hormone deficiency who have already completed a prior TransCon trial. The goal is to see if the weekly shot remains safe and effective over the long term. About 300 children from several countries are taking part, and all receive the active drug. The main focus is on safety, with growth rate and hormone levels also tracked.

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 (lonapegsomatropin), a once-weekly injection of long-acting growth hormone
What this could lead to
If successful, this could offer children with growth hormone deficiency a more convenient once-weekly treatment instead of daily injections, potentially improving adherence and growth outcomes.
What could go wrong
This is an extension trial, so participants already know the drug is safe and effective in the short term. However, long-term risks are still being studied, and not all children may respond equally.

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

298 people

The number who actually took part.

Started

Dec 2017

Finished

Feb 2023

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

1 year to 18 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. Children who have completed a prior phase 3 TransCon hGH trial 2. Children who have not permanently discontinued study drug in the prior trial 3. 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. Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications 2. Evidence of closed epiphyses, defined as bone age \> 14.0 years for females or \> 16.0 years for males 3. Major medical conditions unless approved by Medical Expert 4. Known hypersensitivity to the components of the trial medication 5. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver) 6. Pregnancy 7. Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule

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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

  • Ascendis Pharma Investigational Site

    Birmingham, Alabama, 35233, United States

  • Ascendis Pharma Investigational Site

    Los Angeles, California, 90048, United States

  • Ascendis Pharma Investigational Site

    Orange, California, 92868, United States

  • Ascendis Pharma Investigational Site

    Sacramento, California, 95821, United States

  • Ascendis Pharma Investigational Site

    Centennial, Colorado, 80112, United States

  • Ascendis Pharma Investigational Site

    Jacksonville, Florida, 32207, United States

  • Ascendis Pharma Investigational Site

    Orlando, Florida, 32806, United States

  • Ascendis Pharma Investigational Site

    Tallahassee, Florida, 32308, United States

  • Ascendis Pharma Investigational Site

    Saint Paul, Minnesota, 55102, United States

  • Ascendis Pharma Investigational Site

    Jackson, Mississippi, 39216, United States

  • Ascendis Pharma Investigational Site

    Lebanon, New Hampshire, 03756, United States

  • Ascendis Pharma Investigational Site

    Mineola, New York, 11501, United States

  • Ascendis Pharma Investigational Site

    New York, New York, 10029, United States

  • Ascendis Pharma Investigational Site

    Cleveland, Ohio, 44195, United States

  • Ascendis Pharma Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • Ascendis Pharma Investigational Site

    Portland, Oregon, 97227, United States

  • Ascendis Pharma Investigational Site

    Portland, Oregon, 97239, United States

  • Ascendis Pharma Investigational Site

    Dallas, Texas, 75390, United States

  • Ascendis Pharma Investigational Site

    Fort Worth, Texas, 76104, United States

  • Ascendis Pharma Investigational Site

    Charlottesville, Virginia, 22908, United States

  • Ascendis Pharma Investigational Site

    Norfolk, Virginia, 23507, United States

  • Ascendis Pharma Investigational Site

    Tacoma, Washington, 98405, United States

  • Ascendis Pharma Investigational Site

    Yerevan, 0075, Armenia

  • Ascendis Pharma Investigational Site

    Clayton, Victoria, 3168, Australia

  • Ascendis Pharma Investigational Site

    Minsk, 220020, Belarus

  • Ascendis Pharma Investigational Site

    Varna, 9010, Bulgaria

  • Ascendis Pharma Investigational Site

    Tbilisi, 0159, Georgia

  • Ascendis Pharma Investigational Site

    Athens, 11527, Greece

  • Ascendis Pharma Investigational Site

    Auckland, 1010, New Zealand

  • Ascendis Pharma Investigational Site

    Gdansk, 80-952, Poland

  • Ascendis Pharma Investigational Site

    Warsaw, 02-691, Poland

  • Ascendis Pharma Investigational Site

    Izhevsk, 426009, Russia

  • Ascendis Pharma Investigational Site

    Krasnoyarsk, 660022, Russia

  • Ascendis Pharma Investigational Site

    Moscow, 117036, Russia

  • Ascendis Pharma Investigational Site

    Saint Petersburg, 194100, Russia

  • Ascendis Pharma Investigational Site

    Saratov, 410054, Russia

  • Ascendis Pharma Investigational Site

    Ufa, 450008, Russia

  • Ascendis Pharma Investigational Site

    Vologda, 160022, Russia

  • Ascendis Pharma Investigational Site

    Voronezh, 394024, Russia

  • Ascendis Pharma Investigational Site

    Kharkiv, 61093, Ukraine

  • Ascendis Pharma Investigational Site

    Kyiv, 01021, Ukraine

  • Ascendis Pharma Investigational Site

    Odesa, 65031, Ukraine

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