Fractyl Health Reports Positive 6-Month REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® Procedure

Core Insights - Fractyl Health, Inc. announced positive results from the REVEAL-1 Cohort, indicating that participants who lost 24% of total body weight on GLP-1 drugs maintained stable weight and glycemic control for 6 months after a single Revita treatment [1][3][5] - Revita shows potential as a first-in-class therapy for weight maintenance post-GLP-1 therapy, with minimal weight change of 1.5% observed [1][5][7] Study Results - Participants in the REVEAL-1 Cohort lost an average of 24% of total body weight (>50 lbs.) on GLP-1 drugs before receiving Revita treatment [5][9] - After the Revita procedure, participants maintained stable weight with a mean total body weight change of 1.5% ± 1.3% at 6 months [5][9] - Glycemic control was also sustained, with minimal change in HbA1c levels (0.04% ± 0.08%) compared to a ~0.4% increase seen in other studies post-GLP-1 withdrawal [5][9] Safety and Efficacy - The study included 22 participants, with safety data available for all and efficacy data for 17 [5][9] - No serious adverse events were reported, and 36% of participants experienced mild, transient adverse events consistent with prior Revita experiences [5][7] - The average ablation length during the procedure was approximately 16 cm, aligning with previous real-world experiences [5][7] Future Developments - Upcoming clinical data from the REMAIN-1 Midpoint Cohort is expected in January 2026, with additional pivotal data anticipated in H2 2026 [1][12] - Revita has received FDA Breakthrough Device designation for post-GLP-1 weight maintenance, highlighting its potential as a scalable, non-drug alternative for obesity treatment [7][11] Company Overview - Fractyl Health focuses on innovative treatments for metabolic diseases, including obesity and type 2 diabetes, aiming to transform treatment from chronic management to disease-modifying therapies [10][11] - The company has a robust intellectual property portfolio with 35 granted U.S. patents and approximately 45 pending applications [10]