19 completed, 2 active not recruiting, 2 recruiting, 1 approved for marketing. 11 Phase 2, 10 Phase 3, 4 Phase 1, 2 Phase 4.
Follow setmelanotide: new trials by email Literature Review of setmelanotide trials Research Report on setmelanotide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) Setmelanotide - Pseudohypoparathyroidism Type 1a, Obesity | Phase 2 | Enrolling by invitation | Massachusetts General Hospital | 1 | 2026-07-21 | 2026-07-23 |
| A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) Setmelanotide, Placebo - Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form | Phase 3 | Recruiting | Rhythm Pharmaceuticals, Inc. | 39 | 2025-09-23 | 2026-02-12 |
| A Study of Setmelanotide in Patients With Prader-Willi Syndrome Setmelanotide - Prader-Willi Syndrome, Obesity | Phase 2 | Active not recruiting | Rhythm Pharmaceuticals, Inc. | 18 | 2025-03-04 | 2026-02-12 |
| Open-Label Extension Study of Setmelanotide Setmelanotide - Obesity Associated With Defects in Leptin-melanocortin Pathway | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 28 | 2024-10-21 | 2026-07-15 |
| A Trial of Setmelanotide in Acquired Hypothalamic Obesity Setmelanotide, Placebo - Hypothalamic Obesity | Phase 3 | Active not recruiting | Rhythm Pharmaceuticals, Inc. | 143 | 2023-04-26 | 2026-08-10 |
| Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity Setmelanotide - Bardet Biedl Syndrome (BBS), Bardet Biedl Syndrome | Phase 4 | Recruiting | Tom Hühne | 200 | 2023-01-01 | 2026-06-29 |
| Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity Setmelanotide - Bardet-Biedl Syndrome, POMC Deficiency Obesity | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 12 | 2022-03-08 | 2024-11-27 |
| Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway Setmelanotide 2 mg, Setmelanotide 2.5 mg, Setmelanotide 3 mg - Bardet-Biedl Syndrome, POMC Deficiency | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 19 | 2021-12-21 | 2024-11-26 |
| EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway Setmelanotide, Placebo - Obesity, Genetic Obesity | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 296 | 2021-12-10 | 2026-08-06 |
| DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway Setmelanotide, Placebo - Genetic Obesity | Phase 2 | Completed | Rhythm Pharmaceuticals, Inc. | 164 | 2021-11-30 | 2025-07-02 |
| Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants Setmelanotide, Moxifloxacin, Oral Placebo - Healthy | Phase 4 | Completed | Rhythm Pharmaceuticals, Inc. | 77 | 2021-08-05 | 2024-05-03 |
| Open-Label Study of Setmelanotide in Hypothalamic Obesity Setmelanotide - Hypothalamic Obesity | Phase 2 | Completed | Rhythm Pharmaceuticals, Inc. | 18 | 2021-06-07 | 2025-02-07 |
| A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment Setmelanotide - Renal Insufficiency | Phase 1 | Completed | Rhythm Pharmaceuticals, Inc. | 32 | 2020-07-09 | 2021-06-30 |
| Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity Setmelanotide, Placebo - Bardet Biedl Syndrome (BBS), Alström Syndrome (AS) | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 52 | 2018-11-23 | 2023-12-01 |
| Long Term Extension Trial of Setmelanotide Setmelanotide - Obesity Associated With Defects in Leptin-melanocortin Pathway | Phase 2 / Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 205 | 2018-07-15 | 2025-05-31 |
| Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity Setmelanotide, Placebo - Leptin Receptor Deficiency Obesity | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 15 | 2018-01-30 | 2023-05-23 |
| Setmelanotide in a Single Patient With Partial Lipodystrophy Setmelanotide - Hypertriglyceridemia, Obesity | Phase 2 | Completed | Rhythm Pharmaceuticals, Inc. | 1 | 2017-08-15 | 2022-01-04 |
| Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity Setmelanotide, Placebo - Pro-opiomelanocortin (POMC) Deficiency Obesity | Phase 3 | Completed | Rhythm Pharmaceuticals, Inc. | 15 | 2017-02-14 | 2023-09-21 |
| Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity Setmelanotide - Genetic Obesity, Obesity | Phase 2 | Completed | Rhythm Pharmaceuticals, Inc. | 213 | 2017-02-10 | 2023-08-18 |
| Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome Setmelanotide, Placebo - Prader-Willi Syndrome | Phase 2 | Completed | Rhythm Pharmaceuticals, Inc. | 40 | 2015-03-19 | 2023-07-27 |
Showing 20 of 26. Sign in to see all of them.
Obesity (16) · Bardet-Biedl Syndrome (5) · Hyperphagia (5) · Sexual Infantilism (4) · Overweight (3) · Alstrom Syndrome (2) · Prader-Willi Syndrome (2) · Proopiomelanocortin Deficiency (2) · Hypertriglyceridemia (1) · Obesity, Morbid (1) · Optic Nerve Hypoplasia (1) · Pediatric Obesity (1) · Pseudohypoparathyroidism (1) · Renal Insufficiency (1) · Septo-Optic Dysplasia (1)
Rhythm Pharmaceuticals, Inc. (23) · Charite University, Berlin, Germany (1) · Massachusetts General Hospital (1) · Tom Hühne (1)
United States (21) · United Kingdom (11) · Germany (10) · Canada (9) · Netherlands (7) · Spain (7) · France (6) · Greece (4) · Israel (3) · Puerto Rico (3) · Australia (1) · Belgium (1) · Japan (1) · Reunion (1)
David Meeker, MD (17) · Linda Shapiro, M.D., Ph.D. (2) · David Meeker (1) · Elizabeth Stoner, MD (1) · Metin Cetiner, PD Dr. med. (1) · Monica C Skarulis, M.D. (1)
PMID 42821228, PMID 33137293, PMID 35112343, PMID 36961653, PMID 25675384, PMID 34013094, PMID 35797460, PMID 36356613, PMID 36647077, PMID 36722447, PMID 38697184, PMID 39549719, PMID 39561769, PMID 40903014, PMID 41703984, PMID 42418774, PMID 42528856
2017 (3), 2014 (1), 2016 (1), 2018 (1)