FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech

Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system.

Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420.

In September, Fractyl activated the 10th clinical site in the pivotal trial across the U.S. and Europe.

Under the new authorization, the trial can now include a broader set of patients with inadequately controlled T2D despite being on metformin, other antidiabetic agents (ADAs) and long-acting insulin, according to a news release.

In March, Fractyl won FDA breakthrough device designation for the Revita DMR procedure, which it designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease for patients with insulin-treated type 2 diabetes. The procedure aims to minimize or eliminate the need for type 2 diabetes patients to receive insulin treatment.

READ: “How Fractyl Labs is ‘reversing’ type 2 diabetes to reduce or eliminate insulin injections” — an interview with co-founder & CEO Harith Rajagopalan.

Revita DMR has been tested in early pilot clinical studies in approximately 300 patients with various stages of type 2 diabetes, with the company using that clinical experience to announce a deepening of its clinical development program, the Revitalize T2D program.

Fractyl’s Revitalize T2D clinical development program aims to represent multiple parallel ongoing and planned clinical studies seeking to use Revita in different patient populations, ranging from prediabetes to long-acting insulin-treated type 2 diabetes. Revitalize-1 is the first of such clinical studies and is already underway, now with its expanded patient population.

“We are looking forward to continuing our expanded Revitalize-1 study and concurrently embarking on our Revitalize T2D clinical development program, which will be informed in close collaboration with leading academic experts,” Fractyl Health CMO Dr. Juan Carlos Lopez-Talavera said in the release. “We believe the importance of these clinical studies, and the reason patients across the spectrum of T2D are interested in participating, is that we are seeking to address a very important residual unmet need in T2D for patients who remain at risk of the significant complications of the disease.”