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

NCT ID NCT06596135

Completed Disease control Sponsor: Rhythm Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

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.

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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