Open-Label Extension Study of Setmelanotide
← catalyst calendarSponsored by Rhythm Pharmaceuticals, Inc. (industry) · RYTM — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
28actual
Sites
13
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-21 | actual | When the study began enrolling |
| Primary completion | 2026-06-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-24 | actual | The whole study's end, after follow-up |
| First posted | 2024-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Obesity Associated With Defects in Leptin-melanocortin Pathway
Intervention
- Drug: Setmelanotide — also filed as RM-493, Imcivree
Primary outcome
what the primary-completion date above is the date OFSafety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Up to 3 years
Permalink · RYTM's whole pipeline · Catalyst calendar · Every registered study · What changed