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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