Fractyl Health Eyes Q4 Revita Data, Launches Rejuva Gene Therapy Trial

Fractyl Health is advancing two one-time treatment approaches intended to provide durable benefits for obesity, type 2 diabetes and related metabolic diseases. The company’s lead program, Revita, uses an outpatient endoscopic procedure to ablate a section of the duodenum, the first part of the small intestine. This approach is designed to address duodenal dysfunction, which the company views as a root contributor to abnormal nutrient sensing, body weight and glucose regulation in metabolic disease. Fractyl’s second program, Rejuva, is a pancreatic gene therapy platform. Its lead candidate, RJVA-001, has received clearance to begin a first-in-human study, with site activation expected imminently and initial patient enrollment and dosing anticipated later this year. Revita pivotal data are expected in early Q4. The company expects results in early fourth quarter from a 300-patient pivotal trial evaluating Revita following GLP-1-assisted weight loss. The study enrolls patients with obesity but without prior GLP-1 treatment or type 2 diabetes, gives them tirzepatide until they reach at least 15% total body weight loss, and then randomizes eligible participants two-to-one between Revita and a sham procedure. The study’s first co-primary endpoint compares Revita and sham at six months. Fractyl expects the sham arm to regain roughly 10% of body weight, while the Revita group is expected to regain less than half that amount. A second co-primary endpoint evaluates durability at 12 months in the Revita arm, with the FDA requiring that at least 50% of patients maintain at least 5% total body weight loss relative to their pre-GLP-1 baseline. Fractyl expects 12-month data in the first quarter. The company intends to compile the six-month efficacy results and safety package for a filing by year-end, followed by an update to the FDA once 12-month data are available.