Fractyl Health announces REMAIN-1 study met 3-month efficacy endpoint

Fractyl Health (GUTS) announced results from the REMAIN-1 Midpoint Cohort, supporting the potential for Revita to be the first therapy to preserve weight loss after GLP-1 drug discontinuation. At 3 months, Revita-treated patients lost an additional 2.5% total body weight after stopping tirzepatide, while sham patients regained 10%. These results are clinically and statistically significant and provide randomized, blinded evidence that drug-free, durable weight maintenance is possible. They further support Revita as a potential first-in class treatment in a new therapeutic category in obesity care: post-GLP-1 weight maintenance. Data shared are for the treatment period of up to 3 months. The Midpoint Cohort is ongoing, with 6-month randomized data expected in Q1 2026. Clear evidence of Revita activity: The study met its 3-month efficacy endpoint with strong statistical significance, delivering 2.5% further weight loss with Revita even after stopping tirzepatide, versus 10% weight regain in sham-treated patients. Excellent safety and tolerability through 3 months: No Revita-related SAEs or Grade II+ AEs were observed. Side effects were infrequent, mild, and transient, consistent with prior Revita clinical study experience. Positive readthrough to pivotal study: These data strengthen confidence in the ongoing Pivotal Cohort study, which is on track to complete randomization in early 2026, with 6-month topline primary endpoint data and potential PMA filing expected in H2 2026.