Fractyl Health: Revita shows durable weight maintenance, retains up to 84% of GLP-1 loss at 1 year

Fractyl Health reported one-year REMAIN-1 midpoint results showing Revita reduced weight regain and retained up to 84% of GLP-1–induced weight loss in optimized patients.

Key Highlights:

• In mITT (N=45) a single Revita procedure cut weight regain ~40% vs sham at 12 months (LS-mean regain 7.8% vs 13.0%).
• Complete duodenal ablation (>14 cm) maintained ~81% of GLP-1 weight loss vs 48% with sham (LS-mean regain 4.8% vs 13.0%).
• Optimized subgroup (complete ablation + ≥17.5% run-in loss) retained ~84% vs 46% with sham (LS-mean regain 4.1% vs 13.5%).
• Responder rate for maintaining ≥5% total body-weight loss was 73% in mITT and 91% with complete ablation, versus FDA performance goal >50%.
• Favorable safety: no device- or procedure-related serious AEs; overall TEAE rates similar to sham (24% Revita vs 25% sham).

Original SEC Filing:

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