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

CompletedPhase 3

Sponsor: Rhythm Pharmaceuticals, Inc.

Conditions: Obesity, Genetic Obesity

Interventions: Setmelanotide, Placebo

Countries: United States, Canada, France, Germany, Greece, Israel, Netherlands, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 6 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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, Arizona, United States
Scottsdale, Arizona, United States
Los Angeles, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Altamonte Springs, Florida, United States
Suwanee, Georgia, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Dearborn, Michigan, United States
Rochester, Minnesota, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Staten Island, New York, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Plano, Texas, United States
Tacoma, Washington, United States
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