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STEP-1

GI Dynamics announces lead site for US Pivotal Trial of EndoBarrier

The primary endpoint of STEP-1 is reduction in average blood sugar levels (HbA1c) at 12 months of treatment

GI Dynamics has announced the execution of its contract with Brigham and Women’s Hospital in Boston, MA, as the lead clinical site of the US pivotal trial of EndoBarrier. The US pivotal trial of EndoBarrier, STEP-1 (Single Therapy Euglycemic Procedure), formally known as GID 18-1, will begin enrolling patients with type 2 diabetes and obesity during the second half of 2019.

Brigham and Women’s principal investigator (PI), Dr Christopher C Thompson is an associate professor at Harvard Medical School who specializes in gastroenterology, hepatology and endoscopy. He is a board-certified doctor of internal medicine and gastroenterology, who is both the director of endoscopy and director of the bariatric endoscopy fellowship program at Brigham and Women’s. Thompson is the author or co-author of more than 200 publications and has participated in or led numerous clinical trials.

“I am honoured to lead the STEP-1 trial with other forward-thinking clinical sites,” said Thompson. “I have been working diligently with GI Dynamics and some of the world’s leading clinicians over the past three years to bring this pivotal trial of EndoBarrier to the US. It is imperative to find new ways to treat type 2 diabetes and obesity and I believe EndoBarrier will help pave the way.”

The primary endpoint of STEP-1 is reduction in average blood sugar levels (HbA1c) at 12 months of treatment. The pivotal trial will consist of randomised EndoBarrier implant and control arms; both arms will receive identical lifestyle therapy that complies with the most current American Diabetes Association guidelines.

 “Brigham and Women’s is one of the top treatment facilities in the U.S. and a leader in minimally invasive gastrointestinal procedures,” said Stephen Linhares, vice president of clinical and regulatory affairs of GI Dynamics. “It is an honour to have their outstanding team as our lead clinical site for STEP-1. Dr Thompson was instrumental in the company’s efforts to achieve FDA approval for Stage-1 of the US pivotal trial of EndoBarrier and we look forward to supporting his work as the PI for our STEP-1 study.”

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