# DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway

> **NCT04963231** · PHASE2 · COMPLETED · sponsor: **Rhythm Pharmaceuticals, Inc.** · enrollment: 164 (actual)

## Conditions studied

- Genetic Obesity

## Interventions

- **DRUG:** Setmelanotide
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04963231
- **Lead sponsor:** Rhythm Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-11-30
- **Primary completion:** 2023-08-04
- **Final completion:** 2024-09-30
- **Target enrollment:** 164 (ACTUAL)
- **Last updated:** 2025-07-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04963231

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04963231, "DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04963231. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*