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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.
Trial breakdown
By phase
| Phase 2 | 11 |
| Phase 3 | 10 |
| Phase 1 | 4 |
| Phase 4 | 3 |
By status
| Completed | 19 |
| Recruiting | 2 |
| Active, not recruiting | 2 |
| Unknown status | 1 |
| Enrolling by invitation | 1 |
| APPROVED_FOR_MARKETING | 1 |
| Withdrawn | 1 |
Active trials
- Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)Phase 2 · Enrolling by invitation · 1 participants · Massachusetts General Hospital · started 2026-07-21NCT07496463
- A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)Phase 3 · Recruiting · 39 participants · Rhythm Pharmaceuticals, Inc. · started 2025-09-23NCT06760546
- A Study of Setmelanotide in Patients With Prader-Willi SyndromePhase 2 · Active, not recruiting · 18 participants · Rhythm Pharmaceuticals, Inc. · started 2025-03-04NCT06772597
- A Trial of Setmelanotide in Acquired Hypothalamic ObesityPhase 3 · Active, not recruiting · 143 participants · Rhythm Pharmaceuticals, Inc. · started 2023-04-26NCT05774756
- Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic ObesityPhase 4 · Recruiting · 200 participants · Tom Hühne · started 2023-01-01NCT07674290
Most recent registered trials
- Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)Phase 2 · Enrolling by invitation · 1 participants · Massachusetts General Hospital · started 2026-07-21NCT07496463
- A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)Phase 3 · Recruiting · 39 participants · Rhythm Pharmaceuticals, Inc. · started 2025-09-23NCT06760546
- A Study of Setmelanotide in Patients With Prader-Willi SyndromePhase 2 · Active, not recruiting · 18 participants · Rhythm Pharmaceuticals, Inc. · started 2025-03-04NCT06772597
- Open-Label Extension Study of SetmelanotidePhase 3 · Completed · 28 participants · Rhythm Pharmaceuticals, Inc. · started 2024-10-21NCT06596135
- Gastric Sleeve-Induced Weight Loss on Shortness of Breath in ObesityPhase 4 · Withdrawn · University of California, Los Angeles · started 2023-07-09NCT05812183
- A Trial of Setmelanotide in Acquired Hypothalamic ObesityPhase 3 · Active, not recruiting · 143 participants · Rhythm Pharmaceuticals, Inc. · started 2023-04-26NCT05774756
- Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic ObesityPhase 4 · Recruiting · 200 participants · Tom Hühne · started 2023-01-01NCT07674290
- Setmelanotide in Pediatric Participants With Rare Genetic Diseases of ObesityPhase 3 · Completed · 12 participants · Rhythm Pharmaceuticals, Inc. · started 2022-03-08NCT04966741
- Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R PathwayPhase 3 · Completed · 19 participants · Rhythm Pharmaceuticals, Inc. · started 2021-12-21NCT05194124
- EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R PathwayPhase 3 · Completed · 296 participants · Rhythm Pharmaceuticals, Inc. · started 2021-12-10NCT05093634
- DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) PathwayPhase 2 · Completed · 164 participants · Rhythm Pharmaceuticals, Inc. · started 2021-11-30NCT04963231
- Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy ParticipantsPhase 4 · Completed · 77 participants · Rhythm Pharmaceuticals, Inc. · started 2021-08-05NCT05046132
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 2026-09-23.