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A substudy in congenital hypothalamic obesity

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Trial Profile

A substudy in congenital hypothalamic obesity

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Congenital disorders; Hypothalamic disorders; Obesity
  • Focus Therapeutic Use

    • Most Recent Events

    • 25 Nov 2024 New trial record
    • 18 Nov 2024 According to a Rhythm media release, the company plans for a new, 34-week substudy designed to evaluate setmelanotide in 39 patients with congenital hypothalamic obesity aged 4 years and older. Rhythm is seeking approval from the USFDA for this independent substudy as a protocol amendment to the Company's ongoing Phase 3 trial evaluating setmelanotide in patients with acquired hypothalamic obesity. Rhythm anticipates enrolling the first patients in the substudy in Q1 2025.

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