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ACTIVE NOT RECRUITING

NCT05093634

PHASE3

EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway

Sponsor: Rhythm Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway: * POMC or PCSK1 (Sub-study 035a) * LEPR (Sub-study 035b) * SRC1 (Sub-study 035c) * SH2B1 (Sub-study 035d) The objectives and endpoints are identical for these sub-studies.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients With POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway

Key Details

Gender

All

Age Range

6 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

296

Start Date

2021-12-10

Completion Date

2026-12-31

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Obesity Genetic Obesity

Interventions

DRUG

Setmelanotide

Subcutaneous Injection

DRUG

Placebo

Subcutaneous Injection

Inclusion Criteria: * Patients must have a pre-identified: * Heterozygous genetic variant in the POMC gene or PCSK1 gene * Heterozygous genetic variant in the LEPR gene * Homozygous, heterozygous, or compound heterozygous variant in the NCOA1 (SRC1) * Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, or chromosomal 16p11.2 deletion encompassing the SH2B1 gene * Between 6 and 65 years of age at the time of provision of informed consent/assent * Obesity, defined as BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and gender for patients 6 up to 17 years of age * Patient and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent * Patient and/or parent or guardian reports that patient experienced childhood obesity, defined as the patient and/or parent or guardian reporting that the patient was significantly overweight during childhood * Agree to use a highly effective form of contraception throughout the study and for 90 days following the study * Reported history of lifestyle intervention of diet and exercise * Reported history of hyperphagia Key Exclusion Criteria: * Weight loss of 2% or greater in the previous 3 months * Recent history of bariatric surgery * Significant psychiatric disorder(s) * Suicidal ideation, attempt or behavior * Clinically significant pulmonary, cardiac, endocrine/metabolic, hepatic or oncologic disease * Glycated hemoglobin (HbA1C) \>10% at Screening * History of significant liver disease or severe kidney disease * History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism * Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) * Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing * Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide * Significant hypersensitivity to any excipient in the study drug * If female, pregnant or breastfeeding

Locations (56)

Phoenix Children's Hospital

Phoenix, Arizona, United States

HonorHealth Bariatric Center

Scottsdale, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Advent Health

Altamonte Springs, Florida, United States

InQuest Medical Research

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

St. Luke's Hospital

Chesterfield, Missouri, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of Buffalo

Buffalo, New York, United States

Metropolitan Hospital Center

New York, New York, United States

Mount Sinai Hospital

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

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

UPMC Montefiore

Pittsburgh, Pennsylvania, United States

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

Texas Tech

Amarillo, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Biopharma Informatic

Houston, Texas, United States

Rio Grande Valley Endocrine Center

McAllen, Texas, United States

Endocrine Associates of Dallas and Plano

Plano, Texas, United States

MultiCare Health System Institute for Research and Innovation

Tacoma, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc

Marshfield, Wisconsin, United States

University of Alberta - Alberta Diabetes Institute (ADI)

Edmonton, Alberta, Canada

GH Est Hopital Femme Mere Enfant

Lyon, France

Hu Pitie Salpetriere Aphp

Paris, France

Hopital Armand Trousseau

Paris, France

Centre Hospitalier Universitaire (CHU) de Bordeaux

Pessac, France

Hôpital Félix Guyon Bellepierre

Saint-Denis, France

Charite - Universitatsmedizin Berlin

Berlin, Germany

Endokrinologikum Frankfurt

Frankfurt, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitaetsklinikum Ulm

Ulm, Germany

University of Patras School of Medicine

Rio, Greece

Hasharon Hospital

Petah Tikva, Israel

Chaim Sheba MC, Safra Children's Hospital

Ramat Gan, Israel

Erasmus Medisch Centrum

Rotterdam, Netherlands

University of Puerto Rico

San Juan, Puerto Rico

Hospital Sant Joan de Deu, Barcelona

Barcelona, Spain

Hospital Fundación Jimenez Díaz

Madrid, Spain

Hospital Universitario Virgen de la Victoria de Málaga

Málaga, Spain

Hospital General de Valencia

Valencia, Spain

Bristol Royal Hospital for Children

Bristol, United Kingdom

University of Cambridge

Cambridge, United Kingdom

Aintree University Hospital

Liverpool, United Kingdom

London Medical - The London Diabetes Centre

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Clinical Research Directory

EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)