Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06162715
PHASE2/PHASE3

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

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI \> 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who continue with the current standard of care for patients who have previously undergone Gastric Bypass Surgery.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-10-30

Completion Date

2027-12

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Tirzepatide

Tirzepatide will be initiated 12 or 18 months (12 months + 24 weeks) 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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States