Fractyl Health announced today that it activated the 10th clinical site in its pivotal REVITA-T2Di trial in the U.S. and Europe.
Lexington, Mass.-based Fractyl’s trial is enrolling patients with type 2 diabetes who are currently on insulin therapy at sites in New Jersey, Louisiana, Texas, Massachusetts and New York to add to the initial U.S. site at Indiana University Health. Additionally, enrollment is ongoing in Belgium, Italy and the Netherlands.
REVITA-T2Di — a prospective, randomized, double-blind, sham-controlled study expected to enroll more than 300 patients at up to 35 sites in the U.S. and Europe — will evaluate the efficacy of Fractyl’s Revita DMR procedure. The company set a primary endpoint of the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm, according to a news release.
In April, Fractyl garnered FDA breakthrough device designation for its Revita DMR procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. Through the procedure, the company aims to minimize or eliminate the need for type 2 diabetes patients to receive insulin treatment.
Principal investigator Dr. Vivan Fonseca, who serves as assistant dean for clinical research and Tullis-Tulane alumni chair in diabetes at Tulane University School of Medicine, said in the release that the team is excited to participate in a study of a “potentially important addition to the therapeutic armamentarium of physicians treating diabetes.”
“This exciting clinical trial is the first to evaluate the ability of a procedural therapy to reduce or eliminate the need for insulin in patients with advanced type 2 diabetes, a critical therapeutic need. We are grateful to the prestigious medical centers who have partnered with us to carry out this study,” Fractyl CMO Dr. Juan Carlos Lopez-Talavera said. “As we continue to enroll and treat patients at numerous sites in the U.S. and Europe, we remain focused on strong clinical execution with a sense of urgency for the patients we seek to serve.”