GUTS · Fractyl Health, Inc.
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These results give Fractyl stronger evidence that one Revita treatment may help people keep weight off after stopping GLP-1 drugs. Revita participants regained less weight than sham participants, and the study met its main goal. No serious device- or procedure-related events or deaths were reported by the data cutoff. Still, the study is ongoing, and the filing says early FDA feedback is nonbinding and acceptance of a future application is not assured.