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, showing that participants who lost 24% of total body weight on GLP-1 drugs maintained stable weight and glycemic control six months after a single Revita treatment [1][3][6] - Revita demonstrated a mean weight change of 1.5% after six months, significantly lower than the ~10% weight regain observed in third-party studies following GLP-1 withdrawal [1][6] - The company anticipates key clinical data releases in 2026, including the REMAIN-1 Midpoint Cohort data in January and potential PMA filing in H2 2026 [1][13] Company Overview - Fractyl Health focuses on innovative treatments for obesity and type 2 diabetes, aiming to transform metabolic disease management from chronic symptomatic treatment to durable, disease-modifying therapies [11] - The company has a robust intellectual property portfolio with 35 granted U.S. patents and approximately 45 pending applications [11] - Revita, the company's lead product, is designed to remodel the duodenal lining to reverse damage caused by unhealthy diets, and has received FDA Breakthrough Device designation for weight maintenance after GLP-1 drug discontinuation [12] Study Details - The REVEAL-1 Cohort included 22 participants who had lost at least 15% of their body weight on GLP-1 medications and chose to discontinue therapy [9][10] - Participants maintained stable weight and minimal change in HbA1c levels after the Revita procedure, indicating potential for long-term metabolic health [6][8] - The study reported excellent tolerability, with no serious adverse events and mild, transient treatment-emergent adverse events in 36% of participants [6][8] Future Outlook - Fractyl Health is preparing for multiple clinical readouts in 2026, including 1-year data from the REVEAL-1 Cohort and the REMAIN-1 Pivotal Cohort [13] - The company is experiencing rapid clinical enrollment in its pivotal studies, reflecting a strong demand for non-drug alternatives in obesity treatment [8]