Fractyl Health says Revita cuts weight regain vs sham one year after GLP-1 discontinuation in REMAIN-1 trial
GUTS•Next trial milestones
The company said next milestones include REMAIN-1 Pivotal Cohort topline six-month data in early Q4 2026, followed by a potential FDA De Novo submission in late Q4 2026.
REMAIN-1 Midpoint Cohort shows lower weight regain with Revita
Fractyl Health reported positive one-year randomized REMAIN-1 Midpoint Cohort data for its Revita DMR procedure in post-GLP-1 weight maintenance.
Modified intention-to-treat results showed 7.8% weight regain with Revita versus 13.0% with sham, a roughly 40% reduction.
In the complete duodenal ablation subgroup, patients retained about 81% of GLP-1 weight loss versus 48% with sham; regain was 4.8% versus 13.0%.
In the optimized subgroup, patients retained about 84% versus 46% with sham; regain was 4.1% versus 13.5%.
