Business
Fractyl Health Announces Positive Initial Clinical Results Demonstrating Weight Maintenance Following GLP-1 Discontinuation and Revita Procedure in First Patient of the REVEAL-1 Cohort
Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates
About this update from Fractyl Health, Inc.
[{"type":"text","content":" Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), today announces promising initial clinical results from the first patient in the REVEAL-1 open-label cohort of the REMAIN-1 study one-month post GLP-1 drug discontinuation and Revita procedure. These results align with trends observed in prior Revita clinical studies and the Company’s German Real-World Registry. Additionally, the Company is reporting significant progress in its REMAIN-1 pivotal study, which is evaluating weight maintenance after discontinuation of GLP-1 drugs. The high demand to participate in the study underscores the growing need among patients and physicians for an effective alternative to GLP-1 therapy. “These initial results from REVEAL-1 build upon extensive prior research in Revita clinical studies,” said Dr. Shailendra Singh, Director of Bariatric Endoscopy at West Virginia University. “In obesity, people who stop taking GLP-1 drugs are at high risk of rapid weight and metabolic rebound, jeopardizing the hard-won clinical benefits achieved with the drugs initially. For this reason, the unmet need in obesity has shifted from achieving weight loss to achieving sustained maintenance of a lower weight. When combined with other progress in the field, today’s initial data provides real hope that a scalable solution for weight maintenance, meaning the maintenance of clinically meaningful weight loss even in the absence of ongoing medical therapy, is possible.” “The overwhelmingly positive feedback we have received from patients and physicians for the REMAIN-1 study emphasizes the urgent, unmet need for innovative solutions in weight maintenance. Initial observations from REVEAL-1 suggest that GLP-1 drug discontinuation, followed by Revita treatment, was well tolerated without excess appetite, while also enabling maintenance of weight loss. These findings validate our commitment to addressing the most pressi...