Comparing Magnet System Surgery and Semaglutide Medication for Adults with Obesity and Type 2 Diabetes

What this Trial Is About

This trial investigates adults with obesity and type 2 diabetes, comparing two treatments to improve diabetes control. It evaluates the functional improvement of type 2 diabetes by using the Magnet System in a side-to-side duodeno-ileostomy surgery versus semaglutide medication. Participants have a body mass index between 30 and 40 kgm2 and a hemoglobin A1c level of at least 6.5%. The study is sponsored by GT Metabolic Solutions, Inc. and aims to assess how each treatment affects diabetes over time. Participants are randomly assigned to one of two groups one group receives the Magnet System device to create a duodeno-ileostomy through magnetic compression anastomosis, and the other group receives semaglutide medication as a weekly subcutaneous injection up to 2.4 mg or a dose tolerated based on side effects. The study prohibits additional metabolic or bariatric surgeries and the use of other GLP-1 receptor agonists during the study period. The treatment phase lasts up to one year with assessments scheduled accordingly. Throughout the study, participants will undergo evaluations including measurement of their hemoglobin A1c levels at day 360 to determine functional improvement in diabetes control. Researchers will monitor adherence to treatment, safety, and any side effects. Participants will provide informed consent and comply with follow-up visits and assessments for the full duration of the study, which extends to June 2028.

Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes