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Weekly shot may replace daily growth hormone for turner syndrome kids

NCT ID NCT05690386

Disease control Sponsor: Ascendis Pharma Endocrinology Division A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new long-acting growth hormone (lonapegsomatropin) given once a week, compared to the standard daily growth hormone shot, in 48 prepubertal children with Turner syndrome who have not had growth hormone before. The goal is to see if the weekly shot is safe and helps children grow as well as the daily shot. Participants will be randomly assigned to one of three doses of the weekly drug or the daily drug, and their growth will be tracked for up to 2 years, with an optional extension.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

48 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Dec 2027

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.

Ages

1 year to 10 years

Sex

Female participants only

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. Age between 1 and 10 years, inclusive. 2. TS diagnosis via genetic test. 3. Prepubertal status. 4. Naïve to growth hormone therapy or growth hormone secretagogue. 5. Exhibit impaired growth defined by at least one of the following: 1. AHV\< 6 cm/year or \<25ᵗʰ percentile over a time span of 6-18 months for children of 2 years and older. 2. Height (or length for individuals \< 2 years old) \<10ᵗʰ percentile for sex and age according to the 2000 CDC Growth Charts for the United States. 6. Bone age within normal limits for chronological age, defined as no more than 20% above or below chronological age in months or delayed for chronological age (greater than 20% below chronological age), at screening. 7. Biochemically euthyroid (including when on thyroid hormone supplementation). 8. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g. adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout Screening. 9. Fundoscopy at Screening without signs/symptoms of intracranial hypertension or proliferative retinopathy or evidence of any other retinal disease for which growth hormone therapy is contraindicated. 10. Capable of giving signed informed consent. Participants and/or parents or legal guardians of participants must sign an informed consent statement. Assent should be obtained from all participants competent to understand the protocol, per IRB requirements. Exclusion Criteria: 1. Turner Syndrome with presence of Y-chromosomal material on genetic testing and without a history of gonadectomy. 2. Diagnosis of diabetes mellitus. 3. Known history of clinically relevant conditions that may have an effect on growth, e.g. but not limited to celiac disease, malnutrition, treatment with potential growth-influencing medications for Attention-deficit/ hyperactivity disorder (ADHD), etc. 4. Any known, clinically significant, congenital or acquired cardiac/cardiovascular dysfunction that might interfere with growth as determined by transthoracic echocardiogram. 5. Known history or presence of malignancy. 6. Individuals with history of intracranial tumor or cysts, with evidence of growth within the last 12 months prior to Screening. Note - Individuals with a history of intracranial tumor may be eligible if there is no evidence of residual tumor as determined by MRI/CT scan(s) performed within 6 to 12 months prior to screening. 7. Hepatic transaminases (i.e., AST or ALT) above 3 times the upper limit of normal according to the central laboratory at screening. 8. Major medical conditions and/or presence of contraindication to hGH treatment. 9. Abnormal renal function. 10. Clinically relevant systemic illness, acute critical illness, and complications following open heart surgery, abdominal surgery, multiple accidental traumas, acute respiratory failure, or similar conditions within 6 months prior to Screening. 11. Poorly controlled hypertension. 12. Receiving prior or concurrent treatment with any agent that might influence growth or interfere with GH secretion or action such as, but not limited to, non steroidal anabolic agents, sex steroids, etc. 13. Oral/intravenous/intramuscular corticosteroids within 90 days prior to or throughout Screening. 14. Known or suspected hypersensitivity to study intervention(s) or related products. 15. Participation in any other trial involving an investigational compound within 90 days prior to Screening or in parallel to this trial. 16. Any disease or condition that, in the judgement of the investigator, may make the individual unlikely to comply with the protocol or presents undue risk. 17. Female who is pregnant, plans to be pregnant, or is breastfeeding.

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Conditions

The condition(s) this trial relates to.

Turner syndrome

As listed by the trial registrant

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

Turner syndrome

Contacts and locations

Locations

  • Ascendis Pharma Investigational Site

    Palo Alto, California, 94304, United States

  • Ascendis Pharma Investigational Site

    San Diego, California, 92123, United States

  • Ascendis Pharma Investigational Site

    Aurora, Colorado, 80045, United States

  • Ascendis Pharma Investigational Site

    Orlando, Florida, 32827, United States

  • Ascendis Pharma Investigational Site

    St. Petersburg, Florida, 33701-4804, United States

  • Ascendis Pharma Investigational Site

    Atlanta, Georgia, 30322, United States

  • Ascendis Pharma Investigational Site

    Idaho Falls, Idaho, 83404, United States

  • Ascendis Pharma Investigational Site

    Chicago, Illinois, 60611, United States

  • Ascendis Pharma Investigational Site

    Boston, Massachusetts, 02114, United States

  • Ascendis Pharma Investigational Site

    Saint Paul, Minnesota, 55102, United States

  • Ascendis Pharma Investigational Site

    Las Vegas, Nevada, 89113, United States

  • Ascendis Pharma Investigational Site

    Lake Success, New York, 11042, United States

  • Ascendis Pharma Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Ascendis Pharma Investigational Site

    Cincinnati, Ohio, 45229, United States

  • Ascendis Pharma Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • Ascendis Pharma Investigational Site

    Portland, Oregon, 97239, United States

  • Ascendis Pharma Investigational Site

    El Paso, Texas, 79902, United States

  • Ascendis Pharma Investigational Site

    Fort Worth, Texas, 76104, United States

  • Ascendis Pharma Investigational Site

    Seattle, Washington, 98105, United States

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