Clinical trial
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial
Active, not recruiting · Phase 2, Phase 3 · 1 countries · Registry ID NCT06162715
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
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.
Primary outcomes
Change in weight over time.
We will measure the average PAGI SYM score from 0 - 24 weeks in both arms.
Study locations
1 locations were listed when this page was built. The first 40 are shown.