Revita - (REMAIN-1)

June 4, 2026: Fractyl Health, Inc. (NASDAQ: GUTS) announced positive one-year results from the open-label REVEAL-1 Cohort (n=22) evaluating its Revita endoscopic procedure for weight maintenance in people with obesity discontinuing GLP-1 therapy after achieving ≥15% total body weight loss on GLP-1s. With complete one-year efficacy data available for 15 participants (safety n=22), mean total body weight change at one year after a single Revita procedure was 5.3% ± 2.1% (LS means ± SE; n=15); an efficacy estimand in the full analysis set showed 5.8% ± 2.0% (n=22). Participants retained ~78% of prior GLP-1-induced weight loss at one year, and 33% continued to lose weight. The company notes published studies after GLP-1 withdrawal alone have reported ~15% weight regain at similar time points.

Safety/tolerability: no procedure-related serious adverse events; mild transient treatment-emergent AEs in 36% (8/22), all within the first month; no late device-related AEs. HbA1c change was minimal (0.08% ± 0.08%; n=15).

Upcoming catalysts: one-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 and topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026.