Fractyl Health Announces 6-Month Results From Open-Label REVEAL-1 Cohort; Upcoming Randomized 6-Month REMAIN-1 Midpoint Cohort Data Expected In January 2026

Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment

1.5% mean weight change observed with Revita (n=17); published third-party studies after GLP-1 withdrawal alone have shown ~10% weight regain at similar time points

Upcoming randomized 6-month REMAIN-1 Midpoint Cohort data expected in January 2026; topline 6-month Pivotal Cohort data and potential PMA filing anticipated in H2 2026

BURLINGTON, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive 6-month results from its open-label REVEAL-1 Cohort. The REVEAL-1 Cohort is an open-label study in individuals with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. The REVEAL-1 data show that patients who underwent a single Revita procedure after discontinuing GLP-1 therapy maintained both stable body weight and glycemic control through 6 months. The new results highlight Revita's potential as a compelling first-in-class therapy for post-GLP-1 weight maintenance.