Clinical Trial

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

Completed Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-07
minor Completion moved earlier: 2026-12-31 -> 2026-06-30 2026-08-07
Trial Details
NCT Number NCT05093634
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Obesity, Genetic Obesity
Enrollment 296 participants
Start Date 2021-12-10
Primary Completion 2025-12-22 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06