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Researchers track Long-Term safety of growth hormone drug in kids

NCT ID NCT05775523

Knowledge-focused 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 500 children with growth hormone deficiency who are already taking lonapegsomatropin to check for long-term safety risks like cancer or diabetes. It is a non-interventional study, meaning no new treatment is given—just observation under real-world conditions in Europe and the USA. The goal is to better understand the drug's safety over time.

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 500 people

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

Started

Mar 2023

Expected to finish

Mar 2033

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

Patients from centres in Europe and the USA will be eligible for enrollment into the study. Patients may be enrolled in the study if they are on treatment with lonapegsomatropin. The decision to treat the patient with lonapegsomatropin will be made prior to and independently of the decision to invite the patient to enroll into the study. Both patients naïve to GH treatment and patients previously treated with GH therapy will be eligible for enrollment.

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: * Paediatric patients with GHD who are on treatment with lonapegsomatropin * Patients being clinically managed in Europe or the USA * Appropriate written informed consent/assent as applicable for the age of the patient * Patients willing to comply with follow-up requirements of the study Exclusion Criteria: * Patients participating in any interventional clinical trial for short stature * Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment * Patients for whom treatment with lonapegsomatropin is contraindicated * Patients with closed epiphyses * Patients with active malignant tumours * Patients under antitumour therapy within the past 12 months prior to instituting GH therapy * Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

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Conditions

The condition(s) this trial relates to.

Failure to Thrive isolated congenital growth hormone deficiency pituitary dwarfism

As listed by the trial registrant

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

Growth hormone deficiency

How to take part

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

  1. The places running it

    27 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

  • Ascendis Investigational Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Ascendis Investigational Site

    RECRUITING

    Orange, California, 92868, United States

  • Ascendis Investigational Site

    RECRUITING

    Sacramento, California, 95821, United States

  • Ascendis Investigational Site

    RECRUITING

    San Francisco, California, 94143, United States

  • Ascendis Investigational Site

    RECRUITING

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

  • Ascendis Investigational Site

    RECRUITING

    Orlando, Florida, 32806, United States

  • Ascendis Investigational Site

    RECRUITING

    Orlando, Florida, 32827, United States

  • Ascendis Investigational Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Ascendis Investigational Site

    RECRUITING

    Sandy Springs, Georgia, 30350, United States

  • Ascendis Investigational Site

    RECRUITING

    Boise, Idaho, 83712, United States

  • Ascendis Investigational Site

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Ascendis Investigational Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Ascendis Investigational Site

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Ascendis Investigational Site

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Ascendis Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89113, United States

  • Ascendis Investigational Site

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Ascendis Investigational Site

    RECRUITING

    Manchester, New Hampshire, 03104, United States

  • Ascendis Investigational Site

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Ascendis Investigational Site

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Ascendis Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Ascendis Investigational Site

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ascendis Investigational Site

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Ascendis Investigational Site

    RECRUITING

    Dallas, Texas, 75390, United States

  • Ascendis Investigational Site

    RECRUITING

    El Paso, Texas, 79907, United States

  • Ascendis Investigational Site

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Ascendis Investigational Site

    RECRUITING

    Seattle, Washington, 98105, United States

  • Ascendis Pharma Investigational Site

    RECRUITING

    Centennial, Colorado, 80112, United States

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