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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

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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2024

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At a glance

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

    • Most Recent Events

    • 22 Feb 2024 According to Rhythm media release, complete enrollment in two or more substudies in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases will be in the second half of 2024.
    • 21 Nov 2022 Planned primary completion date changed from 1 Sep 2024 to 1 Dec 2024.
    • 14 Jun 2022 Trial design presented at the 104th Annual Meeting of the Endocrine Society

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