Trials / Completed
CompletedNCT04963231
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | SC injection |
| DRUG | Placebo | SC injection |
Timeline
- Start date
- 2021-11-30
- Primary completion
- 2023-08-04
- Completion
- 2024-09-30
- First posted
- 2021-07-15
- Last updated
- 2025-07-02
- Results posted
- 2024-10-24
Locations
36 sites across 8 countries: United States, Canada, Germany, Greece, Israel, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04963231. Inclusion in this directory is not an endorsement.