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

PHASE2CompletedINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

November 30, 2021

Primary Completion Date

August 4, 2023

Study Completion Date

September 30, 2024

Conditions
Genetic Obesity
Interventions
DRUG

Setmelanotide

SC injection

DRUG

Placebo

SC injection

Trial Locations (36)

10029

Mount Sinai, New York

10032

Columbia University, New York

10308

Ten's Medical Center - Pediatric Endocrinology Clinic, Staten Island

17822

Geisinger Clinic, Danville

19104

The Children's Hospital of Philadelphia, Philadelphia

27517

University of North Carolina, Chapel Hill

28009

Hospital Infantil Universitario Nino Jesus, Madrid

28040

Hospital Fundación Jimenez Díaz, Madrid

30071

InQuest Medical Reseacrh, Suwanee

39110

Mississippi Center for Advanced Medicine, Madison

46014

Hospital General de Valencia, Valencia

48105

University of Michigan, Ann Arbor

48126

Metro Detroit Endocrinology Center, Dearborn

55905

Mayo Clinic, Rochester

75231

Endocrine Associates of Dallas and Plano, Dallas

77030

Texas Children's Hospital, Houston

77065

Accurate Clinical Research, Houston

77382

Javara Research, The Woodlands

78229

Clinical Trials of Texas, San Antonio

78503

Rio Grande Valley Endocrine Center, McAllen

79106

Texas Tech, Amarillo

79907

Hector Granados PA, El Paso

85258

HonorHealth Bariatric Center, Scottsdale

89075

Universitaetsklinikum Ulm, Ulm

5265602

Chaim Sheba MC, Safra Children's Hospital, Ramat Gan

01655

UMass Memorial Medical Center, Worcester

T6G 2E1

University of Alberta, Edmonton

Unknown

Charite - Universitatsmedizin Berlin, Berlin

University of Patras School of Medicine, Pátrai

Bristol Royal Hospital for Children, Bristol

University of Cambridge, Cambridge

04103

Universitaetsklinikum Leipzig, Leipzig

3015 GD

Erasmus Medisch Centrum, Rotterdam

08950

Hospital Sant Joan de Deu, Barcelona

NW1 2PG

London Medical - The London Diabetes Centre, London

WC1E 6JF

University College London Hospitals NHS Foundation Trust, London

All Listed Sponsors
lead

Rhythm Pharmaceuticals, Inc.

INDUSTRY

NCT04963231 - DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway | Biotech Hunter | Biotech Hunter