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DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT04963231•Rhythm Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have had a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity
•Age 6 to 65 years, inclusive
•Obesity, defined as Body Mass Index (BMI) ≥40 kilograms per square meter (kg/m\^2) for participants ≥18 years of age or BMI ≥97th percentile for age and gender for participants 6 to \<18 years of age
•Study participant and/or parent or guardian were able to understand all study procedures and provide consent/assent
•Use of highly effective contraception
•Symptoms or behaviors of hyperphagia

Exclusion Criteria

•Participants with the following genetic variants: biallelic Bardet-Biedl Syndrome (BBS); biallelic Alström Syndrome 1 (ALMS1); homozygous, heterozygous, or compound heterozygous variants in MC4R, Pro-opiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK1), Leptin receptor (LEPR), nuclear receptor coactivator 1 (NCOA1; steroid receptor coactivator-1 \[SRC1\]) or SRC homology 2 B adapter protein 1 (SH2B1) genes as well as 16p11.2 chromosomal deletions that included the SH2B1 gene
•Recent intensive diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that had resulted in weight loss \>2% within previous 3 months
•Bariatric surgery within the previous 6 months
•Documented diagnosis of current unstable major psychiatric disorder or a documented worsening of psychiatric condition that required changes in treatment within 2 years
•Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) or Patient Health Questionnaire 9 (PHQ 9) score of ≥15 during Screening, any suicide attempt in participant's lifetime years, or any suicidal behavior in the last month.
•Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study
•Has significant features of (or meets the diagnostic criteria for) a genetic syndrome that is associated with obesity
•Glycated hemoglobin (HbA1C) \>10.0% at Screening
•History of significant liver disease
•Glomerular filtration rate (GFR) \<30 milliliter per minute (mL/min) at Screening
+6 more criteria

Locations (36)

HonorHealth Bariatric Center

Scottsdale, Arizona, United States

InQuest Medical Reseacrh

Suwanee, Georgia, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Metro Detroit Endocrinology Center

Dearborn, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States

Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

Ten's Medical Center - Pediatric Endocrinology Clinic

Staten Island, New York, United States

Key Dates

Start Date

November 30, 2021

Primary Completion Date

August 4, 2023

Completion Date

September 30, 2024

Last Updated

July 2, 2025

Enrollment

164

ACTUAL participants

Conditions

Genetic Obesity

Interventions

Setmelanotide

DRUG

Placebo

DRUG