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Could a weekly shot replace daily growth hormone for kids?

NCT ID NCT01947907

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests a new long-acting growth hormone called ACP-001, given as a once-weekly injection, in children with growth hormone deficiency. It compares the safety and effectiveness of this weekly shot to the standard daily growth hormone injections over six months. The goal is to see if the weekly option can provide similar growth benefits with fewer injections.

What this could mean

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

Active substance
ACP-001 (long-acting growth hormone)
What this could lead to
If successful, this could allow children with growth hormone deficiency to receive treatment with just one injection per week instead of daily shots, improving convenience and quality of life.
What could go wrong
This is an early-phase trial with only 53 participants, so results may not apply to all children. The weekly injection may not work as well as daily therapy, and there could be unknown side effects.

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

53 people

The number who actually took part.

Start date

Jul 2013

Finished

Sep 2015

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, Tanner stage 1 * Diagnosis of GHD, confirmed by two stimulation tests * Bone age not greater than chronological age * Impaired height and height velocity * BMI within +/- 2 SD (standard deviations) * Baseline IGF-1 (insulin-like growth factor) * Normal fundoscopy * Stable hormonal replacement therapy (other than hGH) * Written Informed Consent Exclusion Criteria: * Prior exposure to rhGH or IGF-I * Past or present intracranial tumor; history or presence of malignant disease * Small for gestational age (SGA) * Malnutrition * Psychosocial dwarfism * Coeliac disease * Anti-hGH antibodies * Diabetes mellitus * Chromosomal abnormalities (e.g. Turner syndrome, SHOX) * Closed epiphyses * Known or suspected HIV infection

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Conditions

The condition(s) this trial relates to.

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 (GHD)

Contacts and locations

Locations

  • 2nd Children City Clinic

    Minsk, Belarus

  • Ain Shams University Hospital

    Cairo, Egypt

  • Ankara University School of Medicine

    Ankara, Turkey (Türkiye)

  • Bashkir State Medical University

    Ufa, Russia

  • Buda Children's Hospital

    Budapest, Hungary

  • Cairo University Hospital

    Cairo, Egypt

  • Children's Hospital of Athens "P. A. Kyriakou"

    Athens, Greece

  • Children's Memorial Health Institute Warsaw

    Warsaw, Poland

  • Children's University Hospital

    Ljubljana, Slovenia

  • Donetsk Regional Children Clinical Hospital

    Donetsk, Ukraine

  • Ege Üniversity

    Izmir, Turkey (Türkiye)

  • El Mansoura University Hospital

    El Mansoura, Egypt

  • El Shatby University Hospital

    Alexandria, Egypt

  • Emergency Clinical Hospital Cluj-Napoca

    Cluj-Napoca, Romania

  • Federal State Budgetary Institution

    Moscow, Russia

  • Heim Pal Children's Hospital

    Budapest, Hungary

  • Hôpital Femme-Mère-Enfant

    Lyon, France

  • Hôpital Jeanne de Flandre

    Lille, France

  • Hôpital des enfants Pellegrin

    Bordeaux, France

  • Institute of Endocrinology and Metabolism

    Kiev, Ukraine

  • Kharkiv National Medical University

    Kharkiv, Ukraine

  • Louis Turcanu Emergency Hospital for Children Timisoara

    Timișoara, Romania

  • Masaryk´s Hospital

    Ústí nad Labem, Czechia

  • Medical University of Lublin

    Lublin, Poland

  • Odessa National Medical University

    Odesa, Ukraine

  • Regional Hospital N°2 Rzeszow

    Rzeszów, Poland

  • Samara State Medical University

    Samara, Russia

  • St. Petersburg State Pediatric Medical Academy

    Saint Petersburg, Russia

  • St. Spiridon County Clinic Emergency Hospital

    Iași, Romania

  • Ukrainian Children Specialized Clinical Hospital

    Kiev, Ukraine

  • University Children's Hospital Magdeburg

    Magdeburg, Germany

  • University Hospital Leipzig

    Leipzig, Germany

  • University Medical Hospital

    Katowice, Poland

  • University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Marina"

    Varna, Bulgaria

  • University of Pecs

    Pécs, Hungary

  • University of Szeged

    Szeged, Hungary

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