A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
← catalyst calendarNCT06760546 · readout in 206 d
Sponsored by Rhythm Pharmaceuticals, Inc. (industry) · RYTM — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
39estimated
Sites
11
Countries
United Kingdom, 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 | 2025-09-23 | actual | When the study began enrolling |
| Primary completion | 2027-03-13 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-03-13 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hypothalamic Obesity
- Multiple Pituitary Hormone Deficiency Genetic Form
- Septo-Optic Dysplasia
- Optic Nerve Hypoplasia
- Childhood-onset Combined Pituitary Hormone Deficiency
- Pituitary Stalk Interruption Syndrome
Interventions
- Drug: Setmelanotide — also filed as RM-493, Imcivree
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFMean % change in BMI
measured From Baseline after 26 weeks on a therapeutic regimen
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