Fractyl Health announced positive clinical results from its German Real-World Registry, demonstrating meaningful and sustained weight loss and improved blood sugar control for at least one year following a single Revita endoscopic procedure. The data, derived from a cohort of 11 patients with obesity and uncontrolled Type 2 Diabetes (T2D), showcase the potential of Revita as a durable therapeutic option.
The study followed patients for 12 months post-Revita procedure. These patients had a median age of 62 years, with obesity and advanced T2D, a median body weight of 111 kilograms (245 pounds; BMI 32 kg/m2) and median baseline HbA1c of 9.6% despite using up to three glucose lowering agents. Approximately two-thirds of these patients were male.
Key Findings from the German Registry
At 12 months, the patients' median weight decreased from 111 kg to 97 kg, representing a nearly 13% total body weight loss. Their median HbA1c also decreased substantially from 9.6% to 7.2%. Furthermore, the number of glucose-lowering medications remained stable or decreased for 10 out of the 11 patients at 12 months.
Weight loss was observed as early as one month post-Revita procedure and was generally maintained throughout the one-year follow-up period. Revita was well-tolerated in these patients, with no procedure-related adverse safety events reported.
Expert Commentary
Professor Stephan Martin, Director of the West German Diabetes Center of Excellence, commented on the results: "These are compelling initial results for one of the hardest to treat patient populations – older people living with obesity and uncontrolled T2D...From what I have seen, I believe patients with obesity and T2D who are looking for an alternative to ongoing medication escalation should consider Revita in conjunction with a diet and exercise program to potentially change the trajectory of their disease."
About Revita
Revita is an outpatient endoscopic procedure designed to resurface the mucosal lining of the duodenum. This resurfacing aims to address the dysfunctional nutrient sensing and signaling mechanisms in the gut that contribute to metabolic diseases like obesity and T2D. By remodeling the duodenal lining, Revita has the potential to be a disease-modifying therapy targeting a root cause of these conditions.
Ongoing Clinical Trials
Fractyl Health is currently conducting the REMAIN-1 study for Revita in weight maintenance, which has received FDA Breakthrough Device designation. They are also enrolling patients in the REVITALIZE-1 study in T2D. Data readouts from the open-label study in weight maintenance are anticipated in the fourth quarter of 2024, with a mid-point analysis of REMAIN-1 expected in Q2 2025.
