Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)
Massachusetts General Hospital · Pseudohypoparathyroidism Type 1a · Obesity
Phase 2
Enrolling by invitation
1
2026-07
Evidence dashboardStudies since 2012Updated Jul 31, 2026
SetmelanotideClinical Trials.
A source-linked view of every Setmelanotide study in the current snapshot—status, phase, enrollment, results, publications, locations and changes over time.
- Total trials
- 27
- Recruiting
- 2
- Completed
- 18
- Terminated
- 0
- Results posted
- 14
- Average enrollment
- 71
- Countries
- 14
- Highest phase
- Phase 4
Largest indexed study
296 participants · NCT05093634 →Developer / research origin
Rhythm Pharmaceuticals
Evidence summary
Activity is not efficacy.
Setmelanotide appears in 27 indexed studies: 2 recruiting, 18 completed and 14 with registry results posted. The highest registered development stage in this snapshot is Phase 4. These counts measure registry activity; they do not establish that Setmelanotide is safe or effective.
Review the design, endpoints, population, protocol changes, statistical analysis and publications before drawing conclusions.
Current studies
Recruiting or active
Completed studies
Finished records
Stopped studies
Withdrawn or terminated
NCT IDStudyPhase / statusEnrollmentUpdated
Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity
Tom Hühne · Bardet Biedl Syndrome (BBS) · Bardet Biedl Syndrome
Phase 4
Recruiting
200
2026-06
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc. · Hypothalamic Obesity
Phase 3
Active, not recruiting
143
2026-05
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Rhythm Pharmaceuticals, Inc. · Hypothalamic Obesity · Multiple Pituitary Hormone Deficiency Genetic Form
Phase 3
Recruiting
39
2026-02
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Rhythm Pharmaceuticals, Inc. · Prader-Willi Syndrome · Obesity
Phase 2
Active, not recruiting
18
2026-02
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Rhythm Pharmaceuticals, Inc. · Obesity · Genetic Obesity
Phase 3
Active, not recruiting
296
2026-02
NCT IDStudyPhase / statusEnrollmentUpdated
Open-Label Extension Study of Setmelanotide
Rhythm Pharmaceuticals, Inc. · Obesity Associated With Defects in Leptin-melanocortin Pathway
Phase 3
Completed
28
2026-07
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
Rhythm Pharmaceuticals, Inc. · Genetic Obesity
Phase 2
Completed
164
2025-07
Long Term Extension Trial of Setmelanotide
Rhythm Pharmaceuticals, Inc. · Obesity Associated With Defects in Leptin-melanocortin Pathway
Phase 2 / Phase 3
Completed
205
2025-05
Open-Label Study of Setmelanotide in Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc. · Hypothalamic Obesity
Phase 2
Completed
18
2025-02
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
Rhythm Pharmaceuticals, Inc. · Bardet-Biedl Syndrome · POMC Deficiency Obesity
Phase 3
Completed
12
2024-11
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
Rhythm Pharmaceuticals, Inc. · Bardet-Biedl Syndrome · POMC Deficiency
Phase 3
Completed
19
2024-11
Showing 6 of 18 studies
NCT IDStudyPhase / statusEnrollmentUpdated
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
University of California, Los Angeles · Dyspnea · Quality of Life
Phase 4
Withdrawn
0
2025-02
Full study index
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Add status, phase, condition, country, result and publication filters inside this molecule’s indexed study set.
27 matching studies
Last registry update first
Latest publications
Follow the paper trail.
PMID 29031731 ↗Collet TH, Dubern B, Mokrosinski J, Connors H, Keogh JM, Mendes de Oliveira E, Henning E, Poitou-Bernert C, Oppert JM, Tounian P, Marchelli F, Alili R, Le Beyec J, Pepin D, Lacorte JM, Gottesdiener A, Bounds R, Sharma S, Folster C, Henderson B, O'Rahilly S, Stoner E, Gottesdiener K, Panaro BL, Cone RD, Clement K, Farooqi IS, Van der Ploeg LHT. Evaluation of a melanocortin-4 receptor (MC4R) agonist (Setmelanotide) in MC4R deficiency. Mol Metab. 2017 Oct;6(10):1321-1329. doi: 10.1016/j.molmet.2017.06.015. Epub 2017 Jul 8.Linked from NCT07674290PMID 31636637 ↗Kamermans A, Verhoeven T, van Het Hof B, Koning JJ, Borghuis L, Witte M, van Horssen J, de Vries HE, Rijnsburger M. Setmelanotide, a Novel, Selective Melanocortin Receptor-4 Agonist Exerts Anti-inflammatory Actions in Astrocytes and Promotes an Anti-inflammatory Macrophage Phenotype. Front Immunol. 2019 Oct 4;10:2312. doi: 10.3389/fimmu.2019.02312. eCollection 2019.Linked from NCT07674290PMID 40674128 ↗Talbi R, Stincic TL, Ferrari K, Ji Hae C, Walec K, Medve E, Gerutshang A, Leon S, McCarthy EA, Ronnekleiv OK, Kelly MJ, Navarro VM. POMC neurons control fertility through differential signaling of MC4R in kisspeptin neurons. Elife. 2025 Jul 17;13:RP100722. doi: 10.7554/eLife.100722.Linked from NCT07674290PMID 36647077 ↗Forsythe E, Haws RM, Argente J, Beales P, Martos-Moreno GA, Dollfus H, Chirila C, Gnanasakthy A, Buckley BC, Mallya UG, Clement K, Haqq AM. Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. doi: 10.1186/s13023-022-02602-4.Linked from NCT07674290PMID 36356613 ↗Haqq AM, Chung WK, Dollfus H, Haws RM, Martos-Moreno GA, Poitou C, Yanovski JA, Mittleman RS, Yuan G, Forsythe E, Clement K, Argente J. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alstrom syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period. Lancet Diabetes Endocrinol. 2022 Dec;10(12):859-868. doi: 10.1016/S2213-8587(22)00277-7. Epub 2022 Nov 7.Linked from NCT07674290PMID 37365323 ↗Sweeney P, Gimenez LE, Hernandez CC, Cone RD. Targeting the central melanocortin system for the treatment of metabolic disorders. Nat Rev Endocrinol. 2023 Sep;19(9):507-519. doi: 10.1038/s41574-023-00855-y. Epub 2023 Jun 26.Linked from NCT07674290PMID 12471214 ↗Barnett S, Reilly S, Carr L, Ojo I, Beales PL, Charman T. Behavioural phenotype of Bardet-Biedl syndrome. J Med Genet. 2002 Dec;39(12):e76. doi: 10.1136/jmg.39.12.e76. No abstract available.Linked from NCT07674290PMID 39533427 ↗Cetiner M, Finkelberg I, Schiepek F, Pape L, Hirtz R, Buscher AK. Ultrasound evaluation of kidney and liver involvement in Bardet-Biedl syndrome. Orphanet J Rare Dis. 2024 Nov 12;19(1):425. doi: 10.1186/s13023-024-03400-w.Linked from NCT07674290
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