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

NCT ID NCT02781727

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a once-weekly injection of TransCon hGH works as well as daily growth hormone injections in prepubertal children with growth hormone deficiency. About 150 children who have not received growth hormone treatment before will receive either the weekly shot or daily injections for 52 weeks. The main goal is to compare how much the children grow over the year. If successful, this could mean fewer injections for children and their families.

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)
What this could lead to
If successful, children with growth hormone deficiency could switch from daily injections to a single weekly shot, reducing treatment burden.
What could go wrong
This is a phase 3 trial, but results may not confirm non-inferiority or better safety versus daily hGH. Long-term effects beyond 52 weeks are not yet known.

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

162 people

The number who actually took part.

Started

Dec 2016

Finished

Jan 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

3 to 12 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: * Prepubertal children with GHD (either isolated or as part of a multiple pituitary hormone deficiency) in Tanner stage 1 (Tanner 1982) aged: * Boys: 3-12 years, inclusive * Girls: 3-11 years, inclusive * Impaired height (HT) defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS ≤ -2.0) according to the 2000 CDC Growth Charts for the United States Methods and Development, available at http://www.cdc.gov/growthcharts/ * Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay * Bone age (BA) at least 6 months less than chronological age * Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1) * Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is able to read, understand, and sign) Exclusion Criteria: * Children with a body weight below 12 kg * Prior exposure to recombinant hGH or IGF-1 therapy * Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast) at Screening (MRI results from up to 6 months prior to Screening may be accepted) * Children with psychosocial dwarfism * Children with idiopathic short stature * History or presence of malignant disease; any evidence of present tumor growth * Closed epiphyses * Major medical conditions and/or presence of contraindication to hGH treatment * Participation in any other trial of an investigational agent within 3 months prior to Screening

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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 HGH (human growth hormone) Hormones Pituitary diseases

Contacts and locations

Locations

  • Ascendis Pharma Investigational Site

    Birmingham, Alabama, 35233, United States

  • Ascendis Pharma Investigational Site

    Little Rock, Arkansas, 72202, 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

    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

    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

    Oklahoma City, Oklahoma, 73104, United States

  • Ascendis Pharma Investigational Site

    Portland, Oregon, 97239, United States

  • Ascendis Pharma Investigational Site

    Dallas, Texas, 75235, United States

  • Ascendis Pharma Investigational Site

    Fort Worth, Texas, 76104, United States

  • Ascendis Pharma Investigational Site

    Tacoma, Washington, 98405, United States

  • Ascendis Pharma Investigational Site

    Yerevan, 0075, Armenia

  • Ascendis Pharma Investigational Site

    Clayton, 3168, Australia

  • Ascendis Pharma Investigational Site

    Minsk, 220020, Belarus

  • Ascendis Pharma Investigational Site

    Varna, 9010, Bulgaria

  • Ascendis Pharma Investigational Site

    Tbilisi, 0144, Georgia

  • Ascendis Pharma Investigational Site

    Tbilisi, 0159, Georgia

  • Ascendis Pharma Investigational Site

    Tbilisi, 0162, Georgia

  • Ascendis Pharma Investigational Site

    Athens, 11527, Greece

  • Ascendis Pharma Investigational Site

    Milan, 20157, Italy

  • Ascendis Pharma Investigational Site

    Roma, 00165, Italy

  • Ascendis Pharma Investigational Site

    Grafton, 1023, New Zealand

  • Ascendis Pharma Investigational Site

    Warsaw, 02-691, Poland

  • Ascendis Pharma Investigational Site

    Iași, 700111, Romania

  • Ascendis Pharma Investigational Site

    Izhevsk, 426009, Russia

  • Ascendis Pharma Investigational Site

    Kazan', 420138, Russia

  • Ascendis Pharma Investigational Site

    Krasnoyarsk, 620022, Russia

  • Ascendis Pharma Investigational Site

    Moscow, 125373, Russia

  • Ascendis Pharma Investigational Site

    Moscow, 127994, Russia

  • Ascendis Pharma Investigational Site

    Nizhny Novgorod, 603136, Russia

  • Ascendis Pharma Investigational Site

    Novosibirsk, 630048, Russia

  • Ascendis Pharma Investigational Site

    Omsk, 644001, Russia

  • Ascendis Pharma Investigational Site

    Saint Petersburg, 191144, Russia

  • Ascendis Pharma Investigational Site

    Saint Petersburg, 194100, Russia

  • Ascendis Pharma Investigational Site

    Samara, 443079, Russia

  • Ascendis Pharma Investigational Site

    Saratov, 410054, Russia

  • Ascendis Pharma Investigational Site

    Tomsk, 634050, 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

    Izmir, 35100, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Melikgazi, 38039, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Trabzon, 61080, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Kharkiv, 61093, Ukraine

  • Ascendis Pharma Investigational Site

    Kyiv, 01021, Ukraine

  • Ascendis Pharma Investigational Site

    Kyiv, 04114, Ukraine

  • Ascendis Pharma Investigational Site

    Odesa, 65031, Ukraine

  • Ascendis Pharma Investigatonal Site

    Gdansk, 80-952, Poland

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