drugset / Trial / NCT06803888

Bariatric Surgery vs. Semaglutide vs. Tirzepatide

NCT06803888

Phase 4 Active not recruiting 125 enrolled Ali Aminian Ethicon, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-29
Primary completion
2027-07-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Semaglutide Peptide 1.7 mg Subcutaneous
Comparator Semaglutide Peptide 2.4 mg Subcutaneous
Comparator Tirzepatide Peptide 10 mg Subcutaneous
Comparator Tirzepatide Peptide 15 mg Subcutaneous

Indications