Fractyl Health Reports Positive Six-Month Results for Revita

Fractyl Health announced positive six-month randomized results from the ongoing REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita for weight maintenance following GLP-1 drug discontinuation. Across the prespecified efficacy population, Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months, consistent with meaningful and sustained attenuation of the expected post-GLP-1 rebound trajectory. An exploratory analysis of patients who achieved above median weight loss during GLP-1 run-in showed that Revita-treated participants experienced 4.2% weight regain versus 13.3% with sham at 6 months, corresponding to an approximately 70% relative reduction in post-GLP-1 weight regain. Revita-treated patients demonstrated improvements in cardiometabolic lipid parameters versus sham at 6 months, including increased HDL cholesterol and reduced triglyceride-to-HDL ratio, suggesting improved metabolic regulation following GLP-1 discontinuation. Revita continued to demonstrate favorable safety and tolerability results through six months, with no treatment-emergent serious adverse events related to the device or procedure, and no study discontinuations due to adverse events. No new related adverse events were observed between 3- and 6-month follow up.