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A Phase 2, Two-Stage (Open-Label Run-in Followed by Randomized Withdrawal), Double-Blind, Placebo-Controlled Study of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway

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A Phase 2, Two-Stage (Open-Label Run-in Followed by Randomized Withdrawal), Double-Blind, Placebo-Controlled Study of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway

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

Latest Information Update: 24 Jun 2024

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Obesity
  • Focus Therapeutic Use
  • Acronyms DAYBREAK
  • Sponsors Rhythm

    • Most Recent Events

    • 20 Jun 2024 Planned End Date changed from 17 Jul 2024 to 31 Aug 2024.
    • 03 Jun 2024 Results published in a Rhythm Pharmaceuticals media release
    • 03 Jun 2024 According to a Rhythm Pharmaceuticals media release, today announced the presentation of the first patient and caregiver reported experiences from qualitative interviews following the completion of a Phase 2 trial that evaluated treatment with setmelanotide in hypothalamic obesity (HO). These results were among six Rhythm presentations at the Endocrine Society Annual Meeting & Expo (ENDO 2024) being held June 1-4 in Boston.

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