Fractyl Health (GUTS) Study result summary

Study design and patient population

• REMAIN-1 is a prospective, randomized, double-blind, sham-controlled pilot study in adults with obesity (BMI 30-45), GLP-1 naïve, no type 2 diabetes, using tirzepatide to achieve at least 15% weight loss before randomization 2:1 to Revita or sham.

• 45 patients were enrolled, with diet and lifestyle counseling throughout, and a 98% retention rate at six months; efficacy analysis included protocol-adherent participants.

• The study was initially designed for three months, not powered for hypothesis testing, with efficacy analysis on 40 protocol-adherent participants.

• The primary endpoint is percent weight regain at six months, with additional subgroup and secondary metabolic analyses.

• The pivotal cohort mirrors this design, is fully enrolled (~315 patients), and top-line data and potential FDA filing are expected in H2 2026.

Key efficacy and clinical results

• Revita-treated patients regained 4.5% of body weight at six months, compared to 7.5% in the sham arm (p=0.07 one-sided), indicating meaningful attenuation of post-GLP-1 rebound.

• In patients with above-median GLP-1-induced weight loss, Revita reduced weight regain by about 70% versus sham at six months (p=0.004), with sham regaining 13% and Revita 4%.

• Approximately 30% of Revita-treated patients maintained or continued to lose weight through six months.

• Revita showed improvements in HDL cholesterol and triglyceride/HDL ratio, markers of improved insulin sensitivity and metabolic regulation.

• Revita-treated patients reported reduced sweet-food cravings, supporting a gut-mediated mechanism for appetite control.

Safety and tolerability

• No new related adverse events or serious device/procedure-related adverse events were observed between three and six months; all related TEAEs were mild and temporary.

• No study discontinuations due to adverse events and safety profile consistent with prior studies.