Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New nasal spray aims to tame relentless hunger in rare genetic disorder

NCT ID NCT06173531

Symptom relief Sponsor: ACADIA Pharmaceuticals Inc. 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tests a nasal spray called carbetocin to reduce the intense, constant hunger (hyperphagia) in people with Prader-Willi syndrome. The study involves 170 participants aged 5 to 30 and lasts 12 weeks. Caregivers will rate changes in hunger-related behaviors using a standard questionnaire.

What this could mean

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

Active substance
carbetocin nasal spray
What this could lead to
If it works, this could provide a new treatment to control the constant, severe hunger that is a hallmark of Prader-Willi syndrome.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not work better than placebo, and side effects from the nasal spray are possible.

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

About 170 people

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

Started

Nov 2023

Expected to finish

Nov 2025

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

5 to 30 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 * Male or female and 5 through 30 years of age * Prader-Willi syndrome with a documented disease-causing mutation * Increased appetite with decreased satiety accompanied by food seeking (consistent with PWS Nutritional Phase 3) * HQ-CT total score of ≥13 at Screening and Baseline * CGI-S score for hyperphagia in PWS of ≥4 at Screening and Baseline * Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits Exclusion Criteria * Genetically diagnosed with Schaaf-Yang syndrome or another genetic, hormonal, or chromosomal cognitive impairment besides PWS * An active upper respiratory infection at the Screening visit or the Baseline visit * Any clinically significant cardiovascular disorder, renal, hepatic, gastrointestinal, or respiratory disease, including severe asthma * History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary * Nasal surgery within 1 month of Screening visit or planning to have nasal surgery during the study. * Unwilling to abstain from nasal saline, other nasal irrigation, and other intranasal medications during the Screening period and through the treatment period of the study * Clinically significant irritability or agitation, requiring initiation of or increase in the dose of antipsychotic medication, within the 6 months prior to the Screening visit * Used prostaglandins, prostaglandin analogues, or prostaglandin agonists in the 3 months prior to the Baseline visit. Inhibitors of prostaglandin synthesis, such as nonsteroidal anti-inflammatory drugs, are not exclusionary. * Started a glucagon-like peptide 1 (GLP-1) agonist within the 6 months prior to the Screening visit. Treatment with GLP-1 agonist is allowed if the subject has been taking it for more than 6 months prior to Screening. * Used oxytocin, desmopressin (DDAVP), tesofensine, diazoxide choline, melanocortin-4 receptor (MC4R) agonists (e.g., setmelanotide), or any medication approved to treat hyperphagia within 6 months prior to the Baseline visit * Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder * History of suicide attempt or inpatient psychiatric hospitalization * New food-related interventions, including environment or dietary restrictions, within 1 month prior to the Screening visit or during the Screening period (i.e., before the Baseline visit) Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hyperphagia in Prader-Willi syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Prader-Willi syndrome

As listed by the trial registrant

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

Hyperphagia in Prader-Willi syndrome

Contacts and locations

Locations

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1, Canada

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Barts Health NHS Trust - The Royal London Hospital

    London, E1 1BB, United Kingdom

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Sainte Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants

    Toulouse, 31059, France

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Christus Children's

    San Antonio, Texas, 78207, United States

  • Cook Children's Health Care System

    Fort Worth, Texas, 79104, United States

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009, Spain

  • Hospital Regional Universitario de Málaga

    Málaga, 29010, Spain

  • KJF Klinik Josefinum gGmbH

    Augsburg, 86154, Germany

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Parc Taulí Hospital Universitari

    Barcelona, 08208, Spain

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85006, United States

  • Rady Children's Hospital San Diego

    San Diego, California, 92123, United States

  • Royal Hospital for Children Glasgow Clinical Research Facility

    Glasgow, G51 4TF, United Kingdom

  • SSM Health/Saint Louis University

    St Louis, Missouri, 63104, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Stanford University School of Medicine

    Palo Alto, California, 94304, United States

  • UPMC-Children's Hospital Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • University of California Irvine

    Orange, California, 92697, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Vanderbilt Clinical Research Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.