DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
Public ClinicalTrials.gov record NCT04963231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT04963231
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Industry
- Enrollment
- 164 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Setmelanotide Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 29, 2021
- Primary completion
- Aug 3, 2023
- Completion
- Sep 29, 2024
- Last update posted
- Jul 1, 2025
2021 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 10
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Bariatric Center | Scottsdale | Arizona | 85258 | — |
| InQuest Medical Reseacrh | Suwanee | Georgia | 30071 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48105 | — |
| Metro Detroit Endocrinology Center | Dearborn | Michigan | 48126 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Mississippi Center for Advanced Medicine | Madison | Mississippi | 39110 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Ten's Medical Center - Pediatric Endocrinology Clinic | Staten Island | New York | 10308 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27517 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Texas Tech | Amarillo | Texas | 79106 | — |
| Endocrine Associates of Dallas and Plano | Dallas | Texas | 75231 | — |
| Hector Granados PA | El Paso | Texas | 79907 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Accurate Clinical Research | Houston | Texas | 77065 | — |
| Rio Grande Valley Endocrine Center | McAllen | Texas | 78503 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Javara Research | The Woodlands | Texas | 77382 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04963231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2025 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04963231 live on ClinicalTrials.gov.