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Fractyl Health reports Revita met six-month co-primary endpoint with 80% weight loss retention vs 67% for sham
GUTSFractyl Health, Inc.
Fractyl Health announced positive topline six-month results from the REMAIN-1 Pivotal Cohort, a randomized, double-blind, sham-controlled study evaluating the Revita DMR System for maintaining weight loss after GLP-1 therapy discontinuation. The trial met its co-primary endpoint with high statistical significance (p=0.0023), showing that Revita participants retained approximately 80% of their GLP-1-induced weight loss compared to 67% in the sham group. Additionally, 32% of Revita patients were weight stable or had further weight loss at six months versus 18% for sham. The company plans to submit a De Novo marketing application to the FDA in late Q4 2026 and expects topline one-year data in Q1 2027. Fractyl Health is a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes.