The EndoBarrier liner, which is implanted into the gut, is a flexible, tube-shaped device that forms a physical barrier between food and a portion of the wall of the intestine.

The double-blind, randomized, multi-center, sham-controlled pivotal 25-site trial, which will enroll up to 500 people is designed to assess the safety and efficacy of EndoBarrier liner in treating patients with obesity and uncontrolled type 2 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.

The company said previously conducted 12 clinical studies on the EndoBarrier liner, outside the US and one in the US, have shown to achieve rapid reductions in blood sugar levels, improvements in cardiovascular risk factors including blood pressure, cholesterol and triglycerides, and weight loss of approximately 20% in 12 months.

GI Dynamics president and chief executive officer Stuart Randle said the company has been rewarding to see the benefits EndoBarrier has brought to people living with type 2 diabetes.

"We look forward to providing updates on the progress of the ENDO trial and to submitting the results for PMA approval to sell EndoBarrier in the United States," Randle added.

In addition to the US, the device is available in selected countries in Europe including Germany, Austria, the UK and the Netherlands, as well as Australia and Chile.