GI Dynamics has a commenced a US pivotal trial of its non-surgical device that is designed to treat patients with obesity and uncontrolled type 2 diabetes.
The flexible, tube-shaped EndoBarrier liner, which is implanted into the gut, forms a physical barrier between food and a portion of the wall of the intestine.
The double-blind, multicentre, randomised, sham-controlled trial, named ENDO, will enrol 500 patients to assess improvements in diabetes over a treatment period of up to 12 months.
The primary endpoint of the trial is improvement in HbA1c, a key blood sugar measure for diabetes, while secondary endpoint forms weight loss and improvements in select cardiovascular risk factors, such as cholesterol.
During previous clinical studies, EndoBarrier has achieved rapid reductions in blood sugar levels and weight loss of approximately 20% in 12 months, according to the company.
The Massachusetts General Hospital’s Obesity, Metabolism and Nutrition Institute director and lead investigator Lee Kaplan said: "Results from the pilot studies of EndoBarrier have been very promising, and we look forward to determining the efficacy and safety of this device in this large, controlled, pivotal trial."
GI Dynamics president and chief executive officer Stuart Randle said: "We appreciate the support of our investigators and clinical trial sites as we begin the process of enrolling patients and executing this landmark clinical trial."
The company’s EndoBarrier device is also available in Europe and Australia for the treatment of type 2 diabetes and obesity for up to 12 months.