melanocortin-4 receptor agonist
Setmelanotide clinical trials
Answer
Setmelanotide has 29 registered trials: 5 running, 19 completed, 1 stopped early. 14 posted results.
Trial registerClinicalTrials.gov and EU CTIS, read 2026-10-03
| Trial | Title | Status | Phase | Registered | Results |
|---|---|---|---|---|---|
| NCT05774756 Trial register | A Trial of Setmelanotide in Acquired Hypothalamic Obesity | running, but no longer enrolling | - | 2023-03-20 | Posted |
| NCT05093634 Trial register | EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway | completed | - | 2021-10-26 | - |
| NCT07496463 Trial register | Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a) | enrolling by invitation only | - | 2026-03-27 | - |
| NCT06596135 Trial register | Open-Label Extension Study of Setmelanotide | completed | - | 2024-09-19 | - |
| NCT07674290 Trial register | Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity | currently recruiting participants | - | 2026-06-29 | - |
| NCT06760546 Trial register | A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) | currently recruiting participants | - | 2025-01-07 | - |
| NCT06772597 Trial register | A Study of Setmelanotide in Patients With Prader-Willi Syndrome | running, but no longer enrolling | - | 2025-01-13 | - |
| 2023-507634-24-00 Trial register | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients with POMC/PCSK1, LEPR, NCOA1 (SRC1) | Not stated | 3 | - | - |
| NCT04963231 Trial register | DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway | completed | - | 2021-07-15 | Posted |
| NCT03651765 Trial register | Long Term Extension Trial of Setmelanotide | completed | - | 2018-08-29 | Posted |
| 2024-516753-45-00 Trial register | SETmelanotide to improve hypothalamic function in the ROHHAD-syndrome; a proof of concept study in a small mono-center cohort: the ROH-SET Study | Not stated | 2 | - | - |
| NCT05812183 Trial register | Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity | withdrawn before enrolling anyone | 4 | 2023-03-31 | - |
| NCT04725240 Trial register | Open-Label Study of Setmelanotide in Hypothalamic Obesity | completed | - | 2021-01-26 | Posted |
| NCT04966741 Trial register | Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity | completed | - | 2021-07-19 | Posted |
| NCT05194124 Trial register | Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway | completed | - | 2022-01-18 | Posted |
| NCT05046132 Trial register | Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants | completed | - | 2021-09-16 | Posted |
| NCT03746522 Trial register | Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Ob | completed | - | 2018-11-19 | Posted |
| NCT02896192 Trial register | Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity | completed | - | 2016-09-12 | Posted |
| NCT03013543 Trial register | Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity | completed | - | 2017-01-06 | Posted |
| NCT01749137 Trial register | Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants | completed | - | 2012-12-13 | Posted |
| NCT02041195 Trial register | Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients | completed | - | 2014-01-20 | Posted |
| NCT02311673 Trial register | Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome | completed | - | 2014-12-08 | Posted |
| NCT03287960 Trial register | Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity | completed | - | 2017-09-19 | Posted |
| NCT05183802 Trial register | An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS) | approved for marketing | - | 2022-01-11 | - |
| NCT03262610 Trial register | Setmelanotide in a Single Patient With Partial Lipodystrophy | completed | - | 2017-08-25 | - |
| NCT04348175 Trial register | A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment | completed | - | 2020-04-16 | - |
| NCT01867437 Trial register | Effects of RM-493 on Energy Expenditure in Obese Individuals | completed | - | 2013-05-22 | - |
| NCT02507492 Trial register | RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients | last verified some time ago; the register no longer confirms its status | - | 2015-05-29 | - |
| NCT02431442 Trial register | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers | completed | - | 2015-04-22 | - |
Source: ClinicalTrials.gov and EU CTIS, read 2026-10-03. Not medical advice.
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