Fractyl today announced positive topline six-month results from the Pivotal Cohort of its ongoing REMAIN-1 study (“Pivotal Cohort”), a 308-participant, multicenter, randomized, double-blind, sham-controlled study of the Revita DMR System (Revita) for weight maintenance in adults with obesity following discontinuation of GLP-1 therapy. REMAIN-1 met its pre-specified six-month co-primary endpoint of weight loss retention, as patients treated with a single Revita procedure demonstrated a highly statistically significant reduction in weight regain compared to sham (p=0.0023).