Fractyl Health announces two-year follow-up data from Revita study

Fractyl Health (GUTS) announced two-year follow-up data from the Germany Real-World Registry study that showed a single Revita procedure led to durable weight loss and improved glucose control in people with obesity and advanced T2D. These data underscore Revita’s potential to provide a potent and durable non-drug alternative for patients struggling with long-term metabolic control. The Germany Real-World Registry study is a prospective, post-market, clinical follow-up study to evaluate the Revita procedure in patients with inadequately controlled T2D. Participants had a baseline HbA1c between 7%-10%, BMI of 45 kg/m, and were on at least one glucose-lowering agent. At baseline, the first nine participants with two years of follow-up had a median age of 62 years, median weight of 104 kg, and a median HbA1c of 9.6%, despite being on up to three GLAs. After a single Revita procedure, these nine participants achieved a median weight loss of 9.6% with weight decreasing from 104 kg to 97 kg at 1 year, a result that was sustained throughout 2 years. Notably, 7 of 8 participants experienced at least a 5% weight reduction, and 5 of 8 saw reductions of 10%. Only one participant, with a history of cortisone therapy known to cause weight gain, experienced modest weight gain. In parallel, median HbA1c reduced by 1.6%, from 9.6% at baseline to 7.2% at 1 year, and this improvement was sustained throughout two years, even as participants reduced or stabilized their use of GLAs. Three patients were on a GLP-1 drug at the time of study entry and were still on a GLP-1 drug through two years of follow-up. No device- or procedure-related serious adverse events have been reported to date. In this cohort, weight loss and glucose improvements began as early as one month after the Revita procedure and were sustained through two years of follow-up. These findings highlight the potential of a single Revita treatment to deliver durable weight maintenance in a real-world setting. Thirty-four participants are currently enrolled in the Germany Real-World Registry study. While the study is no longer enrolling new patients, Fractyl will continue protocol-defined follow-up of participants and share outcomes on an ongoing basis. Revita is being studied in an ongoing IDE-approved REMAIN-1 pivotal study to evaluate its potential safety and efficacy in post-GLP-1 weight maintenance. These new findings from Germany add real-world momentum to Fractyl’s upcoming pivotal trial readouts, including Midpoint Cohort data from its ongoing REMAIN-1 study, which is expected in Q3 2025, and primary endpoint data from the Pivotal Cohort, anticipated in H2 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 for patients with obesity.