Clinical TrialJul 15, 2026, 06:12 AM
Fractyl Health Revita shows 84% weight loss retained at 1 year
AI Summary
Fractyl Health announced positive one-year results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating durable weight maintenance after GLP-1 discontinuation. The study showed Revita significantly reduced weight regain compared to sham, with up to 84% of GLP-1 induced weight loss retained in optimized patient populations. The company reported excellent tolerability with no device-related serious adverse events, reinforcing Revita's potential as a procedural therapy for post-GLP-1 weight maintenance. Fractyl anticipates topline six-month data from the pivotal cohort in early Q4 2026 and a potential FDA De Novo submission in late Q4 2026.
Key Highlights
- Revita reduced weight regain by approximately 40% versus sham at one year in the full mITT population (7.8% vs 13.0% regain).
- Participants with complete duodenal ablation (>14 cm) maintained 81% of GLP-1-induced weight loss vs 48% in sham.
- Optimized population (complete ablation & >=17.5% GLP-1 weight loss) maintained 84% of weight loss vs 46% with sham.
- Weight-maintenance responder rate was 73% in mITT, rising to 91% with complete duodenal ablation.
- No device- or procedure-related serious adverse events occurred, with overall TEAE rates comparable (24% Revita vs 25% sham).
- Topline six-month randomized data from the REMAIN-1 Pivotal Cohort anticipated in early Q4 2026.
- Potential FDA De Novo marketing application submission for Revita expected in late Q4 2026.
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