The trial is taking place at:
G

Geisinger Clinic | Geisinger Danville - Anesthesiology

Veeva-enabled site

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

R

Rhythm Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

Genetic Obesity
Obesity

Treatments

Drug: Placebo
Drug: Setmelanotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05093634
RM-493-035

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

400 participants in 4 patient groups

POMC or PCSK1 variant
Experimental group
Description:
1:1 Randomization
Treatment:
Drug: Setmelanotide
Drug: Placebo
LEPR variant
Experimental group
Description:
1:1 Randomization
Treatment:
Drug: Setmelanotide
Drug: Placebo
NCOA1 (SRC1) variant
Experimental group
Description:
1:1 Randomization
Treatment:
Drug: Setmelanotide
Drug: Placebo
SH2B1 variant
Experimental group
Description:
1:1 Randomization
Treatment:
Drug: Setmelanotide
Drug: Placebo

Trial contacts and locations

56

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Central trial contact

Physician Inquiry: Clinical Trials; Rhythm Clinical Trials

Data sourced from clinicaltrials.gov

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