GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 30, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

December 31, 2027

Conditions
Severe ObesityObesityBMI Greater Than 30
Interventions
DRUG

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.

OTHER

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.

Trial Locations (1)

37209

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER