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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 is a Phase 2 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 164 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Setmelanotide

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2021-11-30
Est. Completion 2024-09-30
Phase Phase 2

Sponsor

Rhythm Pharmaceuticals

23 total trials

What the Registry Record Tells You About NCT04963231

The ClinicalTrials.gov registry entry for NCT04963231 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04963231 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.