Rhythm Pharmaceuticals reports Phase 3 EMANATE trial misses primary endpoints for setmelanotide across four genetic substudies

Reuters03-17 04:01
Rhythm Pharmaceuticals reports Phase 3 EMANATE trial misses primary endpoints for setmelanotide across four genetic substudies

Rhythm reported topline results from the global Phase 3 EMANATE trial of setmelanotide in four genetic substudies of MC4R-pathway obesity, and all four substudies did not meet their pre-specified primary endpoints at Week 52. In the prespecified modified ITT analysis, placebo-adjusted BMI reductions at Week 52 were 0% or greater in POMC/PCSK1 heterozygous patients (-4.3%) and SRC1 (NCOA1) patients (-4%). Post hoc analyses using last observation carried forward found statistically significant BMI reductions at Week 52 in POMC/PCSK1 heterozygous patients (-5.5%; p=0.001) and SRC1 (NCOA1) patients (-6.2%; p<0.0001). The company said the safety profile was consistent with prior studies, with common adverse events including skin hyperpigmentation and injection-site reactions. The results were announced with a conference call scheduled for later the same day, and no separate future scientific presentation was specified.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rhythm Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603161601PRIMZONEFULLFEED9672862) on March 16, 2026, and is solely responsible for the information contained therein.

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