30
Participants
Start Date
October 30, 2024
Primary Completion Date
January 31, 2027
Study Completion Date
December 31, 2027
Tirzepatide
Tirzepatide will be initiated 12 months after patients undergo Roux-en-Y Gastric Bypass. Patients will be started on the lowest dose of 2.5 mg and the dose increased every 6 weeks following an adaptive maximum dose titration protocol. Patients will then complete a final 4 weeks of the study drug.
Standard of Care post-gastric bypass
Patients randomized to the control arm will receive the standard of care for weight maintenance after gastric bypass including dietary guidance provided by the Vanderbilt Surgical Weight Loss handbook. This includes recommendations for 64 oz of fluids per day, ≥60 grams of protein/day, and daily bariatric multivitamins. Patients will continue to have access to dedicated bariatric dietitians, advanced practice providers, and surgeons on an ad hoc basis per patients' request.
Vanderbilt University Medical Center, Nashville
Vanderbilt University Medical Center
OTHER