Fractyl's Revita Meets Pivotal Endpoint, Preserving 80% of GLP-1 Weight Loss
BURLINGTON, Mass. — Fractyl Health (Nasdaq: GUTS) on October 16 reported six-month results from the pivotal cohort of its REMAIN-1 study via GlobeNewswire. The multicenter, randomized, double-blind, sham-controlled trial enrolled 308 participants who first took tirzepatide in a run-in period — losing an average of 18.3% of body weight over about 25 weeks — then discontinued the GLP-1 drug and were randomized 2:1 to Revita or sham. The study met its six-month co-primary endpoint (p=0.0023, modified intent-to-treat): Revita patients retained 80% of their GLP-1-induced weight loss versus 67% for sham, with weight regain of 5.1% versus 8.2%. No device- or procedure-related serious adverse events were reported.
In a post hoc analysis, 32% of Revita patients remained weight-stable or lost further weight versus 18% of sham patients (nominal p=0.020); the subgroup receiving a single complete duodenal ablation of at least 20 cm regained 3.8% versus 8.2% for sham. The second co-primary endpoint is at 12 months, with one-year topline data expected in the first quarter of 2027.
Revita holds FDA Breakthrough Device Designation for post-GLP-1 weight maintenance. Fractyl plans to submit a De Novo marketing application in late Q4 2026, a dedicated CPT code (1122T) takes effect January 1, 2027, and a potential U.S. launch is targeted for early 2028. Chief Executive Harith Rajagopalan said in the release that the results support Revita as an endoscopic treatment for weight maintenance after GLP-1 discontinuation.
Published by GSM · USA (original Chinese edition)
Photo: Fractyl Health公司官方标志 / Fractyl Health official logo
