EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
NCT ID: NCT05093634
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2021-12-10
2025-12-31
Brief Summary
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* 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.
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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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POMC or PCSK1 variant
1:1 Randomization
Setmelanotide
Subcutaneous Injection
Placebo
Subcutaneous Injection
LEPR variant
1:1 Randomization
Setmelanotide
Subcutaneous Injection
Placebo
Subcutaneous Injection
NCOA1 (SRC1) variant
1:1 Randomization
Setmelanotide
Subcutaneous Injection
Placebo
Subcutaneous Injection
SH2B1 variant
1:1 Randomization
Setmelanotide
Subcutaneous Injection
Placebo
Subcutaneous Injection
Interventions
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Setmelanotide
Subcutaneous Injection
Placebo
Subcutaneous Injection
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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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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
Countries
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Other Identifiers
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RM-493-035
Identifier Type: -
Identifier Source: org_study_id
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