A Trial of Setmelanotide in Acquired Hypothalamic Obesity
← catalyst calendarSponsored by Rhythm Pharmaceuticals, Inc. (industry) · RYTM — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
143actual
Sites
28
Countries
Canada, Germany, Japan +3
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 | 2023-04-26 | actual | When the study began enrolling |
| Primary completion | 2025-03-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-16 | estimated | The whole study's end, after follow-up |
| First posted | 2023-03-20 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-29 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hypothalamic Obesity
Interventions
- Drug: Setmelanotide — also filed as RM-493, Imcivree
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFPivotal Cohort: Mean Percent Change From Baseline in Body Mass Index (BMI) After 52 Weeks on a Therapeutic Regimen
measured Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-12-19 · 14.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-03-11 · 1.3 MB · SAP_001.pdf
Publications
- PMID 42418774 — reports results
- PMID 42528856 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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