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

NCT05093634 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Setmelanotide

Subcutaneous Injection

DRUG

Placebo

Subcutaneous Injection

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2025-12-22
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Netherlands
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093634 on ClinicalTrials.gov