Fractyl Health says Revita trial data show 81% GLP-1 weight-loss retention after 1 year off drugs

Fractyl Health, Inc.

Fractyl Health, Inc.

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  • 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.
  • 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%.
  • No device- or procedure-related serious adverse events; topline six-month pivotal data expected early Q4 2026, De Novo filing targeted late Q4 2026.


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