Trial Profile

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

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 18 Aug 2026

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At a glance

11 Aug 2026 According to a Rhythm Health media release, company announced that the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE (setmelanotide) to include the treatment of obesity and control of hunger in adults and children 4 years of age and older with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment.
04 May 2026 Results presented in Rhythm Health the Media Release.
04 May 2026 According to a Rhythm Health media release, data from this trial were presented at The Pediatric Endocrine Society (PES) Annual Meeting, taking place April 30-May 3, 2026, in San Francisco.

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