Fractyl Health says Revita trial data show 81% GLP-1 weight-loss retention after 1 year off drugs
GUTS•Safety and next steps
No device- or procedure-related serious adverse events were reported.
Topline six-month pivotal data are expected early in Q4 2026, with a De Novo filing targeted late in Q4 2026.
REMAIN-1 midpoint cohort results
Fractyl Health reported 12-month REMAIN-1 Midpoint Cohort results showing Revita cut weight regain versus sham following GLP-1 discontinuation.
In the mITT population (N=45), Revita reduced least-squares mean weight regain to 7.8% from 13% with sham.
Weight retention and responder rates
Complete duodenal ablation (>14 cm) retained about 81% of GLP-1 weight loss versus 48% with sham; optimized subgroup retained 84% versus 46%.
Weight-maintenance responder rate was 73% in mITT; 91% with complete ablation, against an FDA performance goal above 50%.
