First Patient Enrolled in U.S. STEP-1 Clinical Trial of EndoBarrier

GI Dynamics Inc., a medical device company that is developing EndoBarrier for patients with type 2 diabetes and obesity, announced that the first patient in the United States (U.S.) STEP-1 clinical trial has been enrolled at Michigan Medicine in Ann Arbor.
 
Michigan Medicine is one of five clinical study sites for the STEP-1 trial; the site is led by principal investigator Allison R. Schulman M.D., M.P.H., assistant professor of gastroenterology and internal medicine.
 
“We are honored to be the first clinical study site to enroll the first patient into the STEP-1 trial,” said Dr. Schulman. “This groundbreaking trial is the first of its kind to measure the primary endpoint of type 2 diabetes combined with reductions in weight, cardiovascular risk, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and chronic kidney disease (CKD). I am excited to help bring an interventional upper gastrointestinal implant procedure for the treatment of multiple metabolic disorders to this patient population.”
 
The STEP-1 trial is the randomized (3 EndoBarrier: 1 Control) controlled, double-blinded pivotal trial of EndoBarrier in the United States. The trial is designed to measure the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication for the treatment of type 2 diabetes and obesity.
 
“We are constantly seeking new methodologies to treat our growing type 2 diabetes and obesity patient population,” said Elif A. Oral, M.D., professor of metabolism, endocrinology and diabetes at Michigan Medicine. “EndoBarrier has shown significant promise in previous studies by addressing high hemoglobin A1c levels and weight as well as other metabolic syndromes, and we look forward to gathering additional data in the STEP-1 trial.”
 
This is the first of 67 patients expected to be enrolled into Stage 1 of the STEP-1 trial. Regardless of what treatment arm the patient is randomized into, all patients will receive identical diabetes medication monitoring and counseling throughout the 24-month study period. Results from the STEP-1 trial will support the company’s pre-market approval application for EndoBarrier to the U.S. Food and Drug Administration (FDA).
 
The STEP-1 trial’s lead principal investigator is Christopher C. Thompson M.D., M.H.E.S. of Brigham and Women’s Hospital and Harvard Medical School in Boston. The five clinical trial sites include Brigham and Women’s Hospital, Michigan Medicine, Baylor College of Medicine, Thomas Jefferson University, and Surgical Specialists of Louisiana.
 
“I have been excited about EndoBarrier since its development and have paid close attention to the positive data that has been released through investigator-initiated studies performed outside of the U.S.,” said Dr. Thompson. “EndoBarrier is a unique device in that it has been shown to produce a clinically and statistically significant impact on type 2 diabetes and obesity as well as on a host of metabolic comorbidities. It is a treatment option that clearly addresses an unmet need for this disease state.”
 
“In addition to measuring the primary endpoint of reduction in blood sugar at 12 months, this landmark study measures a wide variety of metabolic conditions across a two-year period—the first pivotal trial in the U.S. to do so,” said Scott Schorer, president and CEO of GI Dynamics. “We hope to gather evidence to support future research of metabolic disorders and data to support an approval in the U.S. through post-market approval.”
 
The company anticipates full enrollment of the 67 patients by the end of 2020.