A Phase 3 interventional study of Setmelanotide in Obesity Associated With Defects in Leptin-melanocortin Pathway, sponsored by Rhythm Pharmaceuticals, Inc.. Completed at 13 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Rhythm Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 28 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Rhythm Pharmaceuticals, Inc. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 14 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once daily (QD) subcutaneous injection of setmelanotide
Drug: Setmelanotide
Open-label daily injections of setmelanotide
Also known as: RM-493, Imcivree
Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Setmelanotide
Rhythm Pharmaceuticals, Inc. →