Clinical Trial

Bariatric Surgery vs. Semaglutide vs. Tirzepatide

Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-19
Trial Details
NCT Number NCT06803888
Lead Sponsor Ali Aminian
Collaborators: Ethicon, Inc.
Conditions Obesity and Obesity-related Medical Conditions
Enrollment 125 participants
Start Date 2025-01-29
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-18