Clinical TrialJul 15, 2026, 06:02 AM
Fractyl Health Revita Shows 84% GLP-1 Weight Loss Retention at One Year
AI Summary
Fractyl Health announced positive one-year results from its REMAIN-1 Midpoint Cohort for the Revita DMR System, demonstrating significant weight loss retention after GLP-1 discontinuation. The data showed Revita maintained up to 84% of GLP-1 induced weight loss in optimized patients compared to 46% with sham, and reduced weight regain by approximately 40% overall. The company anticipates topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026.
Key Highlights
- Revita retained up to 84% of GLP-1 induced weight loss versus 46% with sham at one year in optimized patients.
- Single Revita procedure reduced weight regain by approximately 40% versus sham in mITT population at one year.
- Participants with complete duodenal ablation (>14 cm) maintained 81% of GLP-1 weight loss vs 48% in sham.
- Weight regain reduced by over 60% versus sham in complete duodenal ablation group.
- Responder rate was 73% in mITT population, rising to 91% in those with complete duodenal ablation.
- Overall TEAE rates were comparable between arms through one year (24% Revita vs 25% sham).
- Topline six-month randomized data from REMAIN-1 Pivotal Cohort anticipated in early Q4 2026.
- Potential FDA De Novo marketing application submission in late Q4 2026.
Price Impact
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