Fractyl's Revita maintains weight loss after GLP-1 stop; 2.5% further loss vs 10% regain in sham (p=0.014)

FRACTYL HEALTH, INC.

Revita-treated patients (n=29) lost additional 2.5% total body weight at 3 months after stopping tirzepatide; sham (n=16) regained 10% (p=0.014).
No Revita-related SAEs or Grade II+ AEs observed; side effects mild/transient, consistent with prior studies.
REMAIN-1 Midpoint Cohort ongoing; 6-month data expected Q1 2026.
Pivotal cohort randomization on track for early 2026; 6-month topline data and potential PMA filing in H2 2026.
Results provide first randomized, blinded evidence of durable drug-free weight maintenance post-GLP-1.

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