Bariatric Surgery vs. Semaglutide vs. Tirzepatide (NCT06803888) | Clinical Trial Compass
RecruitingPhase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
United States125 participantsStarted 2025-01-29
Plain-language summary
The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight reduction in one-year trials, which had not been seen in the past with medical therapy. While the literature suggests that bariatric surgery is superior to these new highly effective medications, there is no head-to-head comparison between the most common bariatric operations (Roux-en-Y gastric bypass \[RYGB\] and sleeve gastrectomy \[SG\]) with semaglutide (once weekly) and tirzepatide (once weekly). The goal of this Randomized Clinical Trial (RCT) is to compare these effective therapies in patients with severe obesity to provide the best evidence to inform clinical decisions in treating patients with obesity.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is a candidate for general anesthesia
✓. Is eligible for bariatric surgery (RYGB or SG) based on ASMBS/IFSO 2022 guidelines
✓. Is ≥18 and ≤70 years old (both inclusive)
✓. has a BMI ≥35 and ≤65 kg/m2 (both inclusive)
✓. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide) for at least 3 months prior to entry, with HbA1c ≤12%.
✓. No weight loss \> 20 lbs. in 3 months before screening (self-reported)
✓. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study.
✓. Is able to understand the options and to comply with the requirements of each arm.
Exclusion criteria
✕. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)