Fractyl Laboratories said today it launched the Revita-2 clinical trial of its Revita DMR procedure in orally-treated type 2 diabetes patients with poorly controlled disease.
The company said that it has enrolled the 1st patient in the trial at a European center participating in the study.
The Revita DMR is a minimally invasive procedure designed to ablate and ‘rejuvenate’ the duodenum (the 1st part of the intestine) in order to alter glucose metabolism, the Lexington, Mass.-based company said.
“Untreated insulin resistance can lead to more severe diseases including fatty liver disease and NASH. The initial clinical data of Revita DMR is encouraging, and there is enormous need for treatments that can change the course of these metabolic diseases,” Jacques Devière of Brussels’ Hôpital Erasme said in a prepared statement.
The Revita-2 clinical trial is a randomized, sham-controlled, blinded study at multiple centers in Europe and will include 3-month glycemic and hepatic endpoints, the company said.
“The clinical data we have gathered to-date suggests Revita DMR may address a significant unmet medical need, which is the underlying insulin resistance in patients with type 2 diabetes who are poorly controlled despite medications. We anticipate that the Revita-2 trial will further build the clinical support about the safety and efficacy of the Revita DMR procedure and inform the design of additional clinical trials,” co-founder & CEO Dr. Harith Rajagopalan said in a press release.
