Fractyl Health has activated the 10th clinical site in its REVITA-T2Di trial in the United States and Europe. The trial is a prospective, randomised, double-blind, sham-controlled study to evaluate the efficacy of Fractyl’s Revita DMR (duodenal mucosal resurfacing) procedure. According to a news release, the company set a primary endpoint of the percentage of those who can achieve HbA1c less than or equal to 7% without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.
In April, Fractyl secured FDA breakthrough device designation for its Revita DMR procedure designed to resurface the upper intestine lining in metabolic disease for people with insulin-treated Type 2 diabetes. The company aims to minimise or eliminate the need for people with Type 2 diabetes to receive insulin treatment through the procedure.
The REVITA-T2Di trial is enrolling people 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 US site at Indiana University Health. Enrolment is also ongoing in Belgium, Italy and the Netherlands.