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NCT04963231 · ClinicalTrials.gov registry record · Phase 2
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
A Phase 2 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
NCT04963231: Completed Phase 2 study, sponsored by Rhythm Pharmaceuticals.
NCT04963231 is a Phase 2 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 164 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04963231, a Phase 2 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
Study 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.
Primary Outcome
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = Kilogram (kg)/ square meter (m\^2). A significant clinically meaningful response was defined as achieving a ≥5% reduction in BMI from Baseline. Data are provided for overall and according to participants with specified primary gene. Baseline was defined as the last available measurement taken prior to the start of treatment Stage 1 administration.
Interventions
- DRUG Placebo
- DRUG Setmelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 2 |
What the finished NCT04963231 record still lists
NCT04963231 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04963231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04963231 about?
NCT04963231 is a clinical study titled "DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway". 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.
What is the current status of trial NCT04963231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2021-11-30. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT04963231?
The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT04963231?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04963231's enrollment target sits among peer trials
164 413th of 2000 higher than 1,583 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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