Rhythm Pharmaceuticals Initiates Dosing in DAYBREAK and Weekly Trials Evaluating Setmelanotide for Rare Genetic Diseases of Obesity

Rhythm Pharmaceuticals Initiates Dosing in DAYBREAK and Weekly Trials Evaluating Setmelanotide for Rare Genetic Diseases of Obesity

Rhythm Pharmaceuticals announced the first patient was dosed with setmelanotide in the Phase 2 DAYBREAK clinical trial to treat the severe obesity and hyperphagia potentially caused by a genetic variant that impairs function of the MC4R pathway. The company also announced the dosing of the first patient in a phase 3 trial evaluating a switch from a daily to a weekly formulation of setmelanotide. Setmelanotide is a melanocortin-4 receptor (MC4R) agonist.

DAYBREAK is a two-stage, double-blind, placebo-controlled trial that will be conducted at more than 75 trial sites across 12 countries. Enrollment will include approximately 500 patients (6 to 65 years old) with severe obesity and a variant in one of 31 genes relevant to the MC4R pathway. Patients demonstrating a clinically meaningful response to setmelanotide at the end of a 16-week, open-label run-in period will be eligible to enter the second stage of the study. Stage 2 will be a 24-week, double-blind, placebo-controlled withdrawal study, in which patients will be stratified into genetically defined cohorts and randomized 2:1 to receive setmelanotide or placebo.

The primary efficacy endpoint is a responder analysis based o...

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