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Fractyl Health Reports Positive 6-Month REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® Procedure
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 BURLING
About this update from Fractyl Health, Inc.
[{"type":"image","alt":"Fractyl Health, Inc.","displaySize":"","headline":null,"caption":"Fractyl Health, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":104,"url":"https://media.zenfs.com/en/globenewswire.com/9ee0df9b33cb03fd3cc1257160c381e5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/grE4KlKD7t64vNihlXguCg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0NjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/9ee0df9b33cb03fd3cc1257160c381e5","width":300,"height":104}},"lazy":false},{"type":"text","content":"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","length":162,"tagName":"p"},{"type":"text","content":"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","length":164,"tagName":"p"},{"type":"text","content":"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","length":167,"tagName":"p"},{"type":"text","content":"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.","length":847,"tagName":"p"},{"type":"text","content":"Key Findings: ","length":13,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Hard-to-treat GLP-1 responder population: Participants lost 24% total body weight (>50 lbs.) on GLP-1 drugs prior to enrollment (duration on GLP-1 therapy ranging from 5 ...