NCT05093634

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Obesity
• Genetic Obesity

Interventions

Type	Name	Description
DRUG	Setmelanotide	Subcutaneous Injection
DRUG	Placebo	Subcutaneous Injection

Timeline

• Start date: 2021-12-10
• Primary completion: 2025-12-22
• Completion: 2026-12-31
• First posted: 2021-10-26
• Last updated: 2026-02-10

Locations

56 sites across 10 countries: United States, Canada, France, Germany, Greece, Israel, Netherlands, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study