Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive 3-month data from the REVEAL-1 Cohort of its ongoing REMAIN-1 pivotal study. These findings suggest Revita may help people stay at their target weight or lose additional weight, even after discontinuing GLP-1 drugs, offering a potential path to durable, drug-free weight maintenance.

3-Month Outcomes in REVEAL-1 Show Strong Early Signal for Durable Weight Maintenance

REVEAL-1 is the open-label cohort within the ongoing REMAIN-1 pivotal study, designed to evaluate the safety, tolerability, and early efficacy signals of Revita in individuals with obesity who have lost at least 15% of their total body weight on a recently discontinued GLP-1 therapy. This cohort serves as an early clinical window into Revita's potential to support durable weight maintenance following GLP-1 discontinuation, a period of time when patients are typically vulnerable to rapid weight regain. Participants undergo a single Revita procedure in an open-label setting and receive structured diet and lifestyle support consistent with the ongoing randomized, controlled, REMAIN-1 clinical study. The insights from REVEAL-1 are intended to inform and complement data from the randomized Midpoint and Pivotal Cohorts in REMAIN-1.

To date, 22 participants have been treated in the REVEAL-1 Cohort, with 3-month follow-up data available for 13 individuals. The profile of the REVEAL-1 Cohort closely mirrors that of the REMAIN-1 Midpoint and Pivotal Cohorts, with an average age of 49 and a gender distribution of 11 women and 2 men. All participants had previously been treated with a GLP-1 therapy for durations ranging from approximately 5 months to 3 years, with a median total body weight (TBW) loss of 20.9% while on therapy. Fifteen percent of participants had pre-diabetes at baseline.

• At 3 months, 12 of 13 participants either lost or maintained their weight after GLP-1 discontinuation and a single Revita procedure. Notably, 6 of 13 experienced further weight loss.
• Median weight remained stable through 3 months (TBW change of 0.46% / ~ 1 pound was within the margin of error for daily weight measurement), compared to the typical 5-6% (10–15 pounds) rebound seen in clinical studies such as SURMOUNT-41 2. Only one participant experienced weight regain similar to that seen after tirzepatide withdrawal.
• Early signs also point to excellent weight stability following Revita procedure, with essentially no weight change between 1 and 3 months (median weight gain at 1 month: 0.43% and 3 months: 0.46%).
• Consistent with prior studies of Revita, the procedure was well tolerated, with no unanticipated or serious adverse effects. No new safety concerns were observed.