Fractyl Health (GUTS) investor relations material

Study design and status

• REMAIN-1 randomized 308 U.S. adults with obesity 2:1 to Revita or sham after a tirzepatide run-in; mean run-in weight loss was 18.3% over 25 weeks.

• The study enrolled adults without type 2 diabetes; the second co-primary endpoint measures whether participants maintain at least 5% weight loss at 12 months.

• REMAIN-1 remains ongoing, with the prespecified second co-primary endpoint assessed at Week 52 and topline results expected in Q1 2027.

Six-month efficacy

• The mITT analysis met the six-month co-primary endpoint: LS mean weight regain was 5.1% with Revita vs 8.2% with sham, a 3.06-point difference (95% CI −5.02 to −1.10; P=0.0023); 80% vs 67% of GLP-1-induced weight loss was retained.

• Sensitivity analyses showed 34%–42% less weight regain with Revita than sham.

• Post hoc analyses found 32% of Revita participants were weight-stable or lost weight vs 18% with sham; 48% retained at least 80% of run-in weight loss vs 30%.

• Treatment effects widened over time, with the difference in weight regain nearly doubling from Month 3 to Month 6.

Treatment extent and safety

• Post hoc analyses found 43% less regain with 12–18 cm treated and 53% less with at least 20 cm treated vs sham; the latter had 3.8% vs 8.2% mean regain (nominal P=0.003).

• No device- or procedure-related serious adverse events, deaths, or unanticipated adverse device effects were reported through Week 26.

• Related adverse events were predominantly mild and transient; 94% occurred within seven days.

• Week 26 visit retention was 94% in both arms; 6% of Revita participants vs 21% of sham participants restarted anti-obesity medication.