Fractyl Health announces three-month data from REVEAL-1 Cohort of REMAIN-1 study

Fractyl Health (GUTS) announced 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. 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 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, compared to the typical 5-6% 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. Consistent with prior studies of Revita, the procedure was well tolerated, with no unanticipated or serious adverse effects. No new safety concerns were observed. Fractyl is advancing toward two key upcoming data readouts from its ongoing pivotal study of Revita: REMAIN-1 Midpoint Cohort data expected in the third quarter of 2025 and 6-month primary endpoint data from the REMAIN-1 Pivotal Cohort expected in the second half of 2026. Together, these clinical milestones are designed to demonstrate Revita’s potential to help maintain weight loss after GLP-1 discontinuation and inform its possible role in supporting durable metabolic outcomes. Revita is being studied in an ongoing IDE-approved pivotal trial to evaluate its potential safety and efficacy in post-GLP-1 weight maintenance.