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Promising drug targets obesity caused by brain damage

NCT ID NCT05774756

Disease control Sponsor: Rhythm 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests a daily injection called setmelanotide to help people aged 4 and older who gained weight after a brain injury (hypothalamic obesity). The goal is to see if it reduces body weight, hunger, and improves quality of life over 52 weeks. Half of the 143 participants will get the drug, half a placebo, and neither they nor their doctors will know which they receive.

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

143 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Apr 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

4 years and older

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.

Key Inclusion Criteria: 1. Documented evidence of acquired hypothalamic obesity (HO) 2. Age 4 years and older 3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \<18 years of age 4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study Key Exclusion Criteria: 1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET) 2. Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \<18 years 3. Bariatric surgery or procedure within last 2 years 4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior 5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease 6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) 7. History or close family history of skin cancer or melanoma 8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose 9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide 10. Inability to comply with once daily (QD) injection regimen 11. If female, pregnant and/or breastfeeding 12. Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL \[POMC, PCSK1, LEPR, collectively\], BBS) prior to the hypothalamic injury. 13. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

acquired hypothalamic obesity Sexual Infantilism

As listed by the trial registrant

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

Hypothalamic obesity

Contacts and locations

Locations

  • Ann and Robert H. Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Birmingham Women and Children's Hospital NHS Trust

    Birmingham, B46NH, United Kingdom

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Minnesota

    Saint Paul, Minnesota, 55102, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hull University Teaching Hospital

    Hull, HU32RW, United Kingdom

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 100029, United States

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73122, United States

  • Medicover Neuroendokrinologie

    München, 81667, Germany

  • Nagano Children's Hospital

    Azumino, Nagano, 399-8288, Japan

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • Ohio State Wexner Medical Center

    Columbus, Ohio, 43203, United States

  • Prinses Maxima Center for Pediatric Oncology

    Utrecht, 3584CS, Netherlands

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Seattle Children's Hospital, Research and Foundation - Center for Integrative Brain Research

    Seattle, Washington, 98101, United States

  • Toranomon Hospital

    Minato, Tokyo, 105-8470, Japan

  • UAN Pediatric Endocrinology

    Birmingham, Alabama, 35233, United States

  • UCL Great Ormond Street Institute of Child Health

    London, WC1N 1EH, United Kingdom

  • Universitaetsklinikum Hamburg-Eppendorf (UKE) - Ambulanzzentrum des UKE GmbH

    Hamburg, 20246, Germany

  • Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin

    Ulm, 89075, Germany

  • University Children's Hospital, Klinikum Oldenburg

    Oldenburg, 26133, Germany

  • University of Florida

    Gainesville, Florida, 32610-0296, United States

  • University of Iowa Stead Family Department of Pediatrics

    Iowa City, Iowa, 52242, United States

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232, United States

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