The Phase 2 DAYBREAK trial is investigating genes with strong or very strong relevance to the 
MC4R pathway

Rhythm’s DAYBREAK trial is the most comprehensive Phase 2 trial ever initiated in rare genetic diseases obesity to evaluate the treatment of severe obesity and hyperphagia potentially caused by a gene variant that impairs function of the MC4R pathway. 

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Rapid and robust proof of concept

DAYBREAK is a two-stage, double-blind, placebo-controlled trial. Stage 1 is a open-label run-in, and Stage 2 is a double-blind, placebo-controlled withdrawal period, with patients randomized 2:1 to receive setmelanotide or placebo.

1Strande et al. Am J Hum Genet. 2017;100:895-906.
Group 1980