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Home / Clinical trials / Setmelanotide

ClinicalTrials.gov · updated 2026-11-09

Are there clinical trials for Setmelanotide?

Established clinical evidence

Setmelanotide has 27 registered clinical trials, including 19 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.

27
Registered studies
26
Interventional trials
19
Completed
5
Currently active

Trial breakdown

By phase

Phase 211
Phase 310
Phase 14
Phase 43

By status

Completed19
Active, not recruiting2
Recruiting2
Enrolling by invitation1
Unknown status1
Withdrawn1
APPROVED_FOR_MARKETING1

Active trials

Most recent registered trials

How to read this. These are counts of studies registered on ClinicalTrials.gov, the US clinical trial registry. Registration is not evidence of benefit, and a registered trial may never report results. Counts are the most complete public measure of research activity, not a verdict on whether a compound works.

What Setmelanotide is being studied for

Most studied conditions

Obesity7
Hypothalamic Obesity3
Genetic Obesity3
Prader-Willi Syndrome2
Overweight2
Bardet-Biedl Syndrome2
Obesity Associated With Defects in Leptin-melanocortin Pathway2
Bardet Biedl Syndrome (BBS)2

Who is running the studies

Rhythm Pharmaceuticals, Inc. (23)
Massachusetts General Hospital (1)
Charite University, Berlin, Germany (1)
Tom Hühne (1)
University of California, Los Angeles (1)
People enrolled across all studies1,843
Completed studies that posted results14 of 19, 74%

Counted from ClinicalTrials.gov registrations, checked 2026-11-09.

Peptides with a similar weight of evidence

Ordered by how far the registered research has progressed.

Frequently asked questions

Are there clinical trials for Setmelanotide?

Setmelanotide has 27 registered clinical trials, including 19 completed interventional studies and trials reaching Phase 4. Its use in humans is supported by established registered clinical evidence.

Does a registered trial mean the peptide works?

No. Registration means a study was formally listed before or during the research. It says nothing about the result. A completed trial can find no benefit, and many registered studies are never published.

What is the difference between a registered trial and published evidence?

Registration records that a study exists. Publication reports what it found. This page counts registrations, which is the more complete picture of research activity, but it is not a measure of proven effectiveness.

Why do phases matter?

Phase 1 tests safety in a small group. Phase 2 looks for early signs of effect. Phase 3 tests effectiveness against a comparator in a large group, and is what regulators normally require. Phase 4 studies happen after approval. A compound with only Phase 1 trials has not been shown to work.

Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine. Studies where Setmelanotide is registered as an intervention. Last updated 2026-11-09.

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