Medical Device Network

FDA expands Fractyl endoscopy trial to include untreated diabetes patients

The endoscopy device trial has seen its remit expanded by the FDA to allow for patients whose type 2 diabetes has gone uncontrolled or untreated.

The US Food and Drug Administration (FDA) has given the green light for metabolic therapeutics company, Fractyl Health, to expand the REVITALIZE-1 clinical study for its endoscopic device to include patients with type 2 diabetes.

The REVITALIZE-1 (NCT04419779) trial is set to examine the company’s device which is designed to address the symptoms of obesity and type 2 diabetes by relining a patient’s duodenum. Previously the trial was set only to examine the device’s effect on patients taking insulin and up to three non-insulin drugs, including GLP-1-based therapies, but now the FDA has given the go-ahead for the trial to involve patients with inadequately controlled diabetes.

Harith Rajagopalan, co-founder and CEO of Fractyl, said: “We are excited about the expansion of the protocol for REVITALIZE-1 because we believe Revita holds unique potential for tackling disease progression and prevention in the huge public health crisis that is T2D.

“For patients currently managing T2D with medications or insulin, Revita aims to enhance glucose regulation and halt or slow down the disease's advancement, representing a paradigm shift in the way in which we treat these patients.”

At the same time, the company is launching its REMAIN-1 trial. The randomised, double-blind trial of Revita will examine patients who have lost at least 15% of total body weight on tirzepatide therapy against a sham therapy. It is expected to begin treating its first cohort of patients in the third quarter of 2024 with mid-point data analysis from this cohort in Q2 2025. The trial is aimed at proving the device’s efficacy by way of a percentage change in body weight from baseline to week 24. Secondary endpoints aim to demonstrate that most patients treated with Revita maintain clinically significant weight loss after stopping tirzepatide.

Rajagopalan added: “If successful and approved, Revita may offer a reliable ‘off-ramp’ to the millions of people currently taking GLP-1 therapies, potentially providing durable weight maintenance without having to continue taking these medications.”

Elsewhere in the field of devices designed for the treatment of diabetes, Tandem Diabetes Care shared positive new data from a user satisfaction and wearability survey that found the majority of patients were satisfied with its automated insulin delivery system, Tandem Mobi. Medtronic also published positive results from a trial of its MiniMed 780G automated insulin delivery system during the American Diabetes Association (ADA) meeting in Orlando, Florida.