Fractyl Health Announces Groundbreaking Data from REMAIN-1 Midpoint Cohort Showing Revita® Maintained Weight Loss After GLP-1 Discontinuation

Core Insights - Fractyl Health, Inc. announced significant results from the REMAIN-1 Midpoint Cohort, indicating that Revita may be the first therapy to maintain weight loss after discontinuation of GLP-1 drugs, with Revita-treated patients losing an additional 2.5% total body weight compared to a 10% regain in sham-treated patients, achieving statistical significance (p=0.014) [2][3][8] Study Design and Results - The REMAIN-1 Midpoint Cohort involved 45 participants who had lost at least 15% of their body weight with tirzepatide, randomized to receive either Revita or a sham procedure after stopping the drug [4] - The study met its primary efficacy endpoint at 3 months, showing Revita's effectiveness in promoting further weight loss while ensuring excellent safety and tolerability, with no serious adverse events reported [8][10] Future Milestones - The ongoing REMAIN-1 Midpoint Cohort is expected to provide 6-month data in Q1 2026, while the Pivotal Cohort aims to complete randomization in early 2026, with topline primary endpoint data and potential PMA filing anticipated in H2 2026 [11]