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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04963231
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 164 participants
Conditions and interventions
Conditions
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 30, 2021 (Actual)
- Primary completion
- Aug 4, 2023 (Actual)
- Completion
- Sep 30, 2024 (Actual)
- Last update posted
- Jul 2, 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 2, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04963231 live on ClinicalTrials.gov.