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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: 5 Independent Sub-studies of Setmelanotide in Patients With POMC, PCSK1, LEPR, SRC1, SH2B1, or PCSK1 N221D Gene Defects in the Melanocortin-4 Receptor Pathway

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: 5 Independent Sub-studies of Setmelanotide in Patients With POMC, PCSK1, LEPR, SRC1, SH2B1, or PCSK1 N221D Gene Defects in the Melanocortin-4 Receptor Pathway

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms EMANATE
  • Sponsors Rhythm

Most Recent Events

  • 07 May 2025 According to Rhythm media release, the company plans to announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026.
  • 26 Feb 2025 According to Rhythm media release, top line data expected first half of 2026.
  • 10 Jan 2025 According to Rhythm media release, completed enrollment in two substudies in Phase 3 EMANATE trial of setmelanotide.

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