DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
NCT ID: NCT04963231
Last Updated: 2025-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2021-11-30
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Stage 1: Setmelanotide (Open-Label)
Participants received once daily SC injection of setmelanotide from Day 1 to Week 16 in an open-label treatment stage (Stage 1). Participants ≥12 years of age started on setmelanotide 2.0 milligrams (mg) once daily for approximately 2 weeks, then increased to 3.0 mg once daily. Participants \<12 years of age started on setmelanotide 1.0 mg once daily for approximately 1 week, then increased to 2.0 mg once daily for approximately 1 week, then increased to 3.0 mg once daily.
Setmelanotide
SC injection
Stage 2: Setmelanotide (Double-Blind)
Participants from Stage 1 who were eligible for Stage 2 received once daily SC injection of setmelanotide 3.0 mg from Week 16 to Week 40 in a double-blind treatment Stage (Stage 2).
Setmelanotide
SC injection
Stage 2: Placebo (Double-Blind)
Participants from Stage 1 who were eligible for Stage 2 received once daily SC injection of matching placebo 3.0 mg from Week 16 to Week 40 in a double-blind treatment Stage (Stage 2).
Placebo
SC injection
Interventions
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Setmelanotide
SC injection
Placebo
SC injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* History or close family history of melanoma or participant history of oculocutaneous albinism
* Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions
* Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
* Participants previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
* Significant hypersensitivity to any excipient in the study drug
* Females who were breastfeeding or nursing
6 Years
65 Years
ALL
No
Sponsors
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Rhythm Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Meeker, MD
Role: STUDY_CHAIR
Rhythm Pharmaceuticals, Inc.
Locations
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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
University of North Carolina
Chapel Hill, North Carolina, United States
Geisinger Clinic
Danville, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Tech
Amarillo, Texas, United States
Endocrine Associates of Dallas and Plano
Dallas, Texas, United States
Hector Granados PA
El Paso, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Rio Grande Valley Endocrine Center
McAllen, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Javara Research
The Woodlands, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
Charite - Universitatsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
University of Patras School of Medicine
Pátrai, , Greece
Chaim Sheba MC, Safra Children's Hospital
Ramat Gan, , Israel
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Hospital Sant Joan de Deu
Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Fundación Jimenez Díaz
Madrid, , Spain
Hospital General de Valencia
Valencia, , Spain
Bristol Royal Hospital for Children
Bristol, , United Kingdom
University of Cambridge
Cambridge, , United Kingdom
London Medical - The London Diabetes Centre
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Trapp CM, Censani M. Setmelanotide: a promising advancement for pediatric patients with rare forms of genetic obesity. Curr Opin Endocrinol Diabetes Obes. 2023 Apr 1;30(2):136-140. doi: 10.1097/MED.0000000000000798. Epub 2023 Feb 1.
Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RM-493-034
Identifier Type: -
Identifier Source: org_study_id
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