A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
← catalyst calendarNCT06239116 · readout in 439 d
Sponsored by Rhythm Pharmaceuticals, Inc. (industry) · RYTM — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
150estimated
Sites
7
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 | 2024-03-05 | actual | When the study began enrolling |
| Primary completion | 2027-11-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-11-01 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-22 | 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
- Prader-Willi Syndrome
- PWS
Interventions
- Drug: Part A: RM-718 or placebo (matched to specific RM-718 dose cohort)
- Drug: Part B: RM-718 or placebo (matched to specific RM-718 dose cohort)
- Drug: Part C: RM-718
- Drug: Part D: RM-718
Primary outcome
what the primary-completion date above is the date OFParts A, B, C, D: Safety and Tolerability Assessed by Number of Study Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
measured From Day 1 through the Safety-Follow-up call (up to Day 43 for all Part A cohorts, up to Day 70 for all Part B cohorts, up to Day 140 for Part C cohort, up to Day 210 for Part D cohort)
Permalink · RYTM's whole pipeline · Catalyst calendar · Every registered study · What changed