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Hope for rare obesity: setmelanotide tested for long-term safety

NCT ID NCT06596135

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study looks at the long-term safety of setmelanotide (Imcivree) in 30 people aged 2 and older with rare genetic obesity. Participants have already completed a previous setmelanotide study and shown benefit. They will receive daily injections to see if the drug remains safe and tolerable over time.

What this could mean

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

Active substance
setmelanotide (Imcivree)
What this could lead to
If successful, this study could confirm that setmelanotide is safe and effective for long-term use in people with rare genetic obesity, potentially leading to a lasting treatment option.
What could go wrong
This is an open-label extension study with only 30 participants, so results may not apply to everyone. Long-term side effects are still being monitored, and the drug requires daily injections.

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

28 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2026

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

2 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: * Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development. * Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after. * Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator. Key Exclusion Criteria: * Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®). * Any new or worsening depression resulting in suicidal thoughts and/or behaviors. * Discontinuation from a previous setmelanotide study. * History or close family history (parents or siblings) of melanoma. * Pregnant and/or breastfeeding women Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Obesity Sexual Infantilism

As listed by the trial registrant

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

Obesity associated with defects in leptin-melanocortin pathway

Contacts and locations

Locations

  • Children's Minnesota

    Saint Paul, Minnesota, 55102, United States

  • Geisinger Health System

    Danville, Pennsylvania, 17821, United States

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612, United States

  • Marshfield Clinical Research Institute

    Marshfield, Wisconsin, 54449, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Seattle Children's Research Institute

    Seattle, Washington, 98105, United States

  • UC San Diego- Rady Children's Hospital

    San Diego, California, 92123, United States

  • University of Buffalo

    Getzville, New York, 14068, United States

  • University of Florida at Gainesville

    Gainesville, Florida, 32611, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232, United States

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421, United States