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

Last updated: March 7, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Enrolling

Phase

2/3

Condition

Diabetes Prevention

Obesity

Treatment

Placebo

Standard of Care post-gastric bypass

Tirzepatide

Clinical Study ID

NCT06162715
VR72411
  • Ages 30-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be able to understand and provide informed consent.

  2. BMI > 30 12 months after bariatric surgery.

  3. Age > 30 and < 65

  4. Patients undergoing primary Roux-en-Y Gastric Bypass

Exclusion

Exclusion Criteria:

  1. Inability or unwillingness of a subject to give written informed consent or complywith the study protocol.

  2. Diagnosis of type I Diabetes

  3. Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric,vertical banded gastroplasty).

  4. Use of medications for type 2 di

  5. Hemoglobin A1c > 8.5 in last 3 months.

  6. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months Asthis would preclude patients from undergoing bariatric surgery.

  7. Personal history of pancreatitis as determined by history.

  8. Personal or family history of medullary thyroid cancer by history or multipleendocrine neoplasia syndrome type 2

  9. Pregnancy by urine testing, current lactation, or plans to become pregnant duringthe study period.

  10. Use of systemic glucocorticoids in the past 28 days

  11. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II)within 1 year by history.

  12. History of solid organ transplant.

  13. History of physician-diagnosed malignancy (other than excised non-melanoma skincancer) in the past 5 years.

  14. Current uncontrolled hypertension (systolic >150, diastolic >90) or untreatedhyperthyroidism.

  15. Current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion ofthe investigator, would interfere with the subject's ability to comply with studyrequirements.

  16. Screening creatinine elevation with EGFR < 60 at time of randomization.

  17. Tobacco use in last 12 months

  18. Pregnancy

  19. Prisoners

  20. Unable or unwilling to follow-up

  21. Unable to understand English/Spanish

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
October 30, 2024
Estimated Completion Date:
December 31, 2027

Study Description

Obesity affects nearly half of the U.S. population, impacting health outcomes including diabetes, cardiovascular risk, longevity, and quality of life. While bariatric surgery such as gastric bypass stands as the most effective intervention, 65% of individuals experience persistent obesity when undergoing surgical weight loss alone. Given the wide-ranging impact of obesity on health outcomes, a critical need exists to explore the efficacy of adjuvant weight loss therapies after gastric bypass surgery. Tirzepatide (TRZ), a type of glucagon-like peptide-1 receptor agonist, shows remarkable effectiveness in medical obesity with 25% weight loss after sustained therapy. However, nearly two-thirds of patients taking medications like TRZ have mild to moderate gastrointestinal (GI) symptoms, including nausea, vomiting, and abdominal pain. These medication side-effects could be a consequence of gastroparesis via vagal stimulation of the stomach, and may represent a major driver of weight loss. Limited data exist regarding use of these newer agents, such as TRZ, in patients who have undergone gastric bypass, which disrupts vagal nerves responsible for managing food transit and gastric emptying. This is a major and timely scientific gap in understanding whether gastric bypass surgery might mitigate these GI symptoms while allowing for enhanced weight loss with adjuvant TRZ use in the post-operative period. The investigators propose a pilot, phase II, open-label trial enrolling patients twelve months after gastric bypass with a nadir Body Mass Index ≥ 30 kg/m2. Study subjects will be randomized to either 24 weeks of TRZ or post-surgery standard of care. Our proposal consists of two aims. First, the investigators will determine the impact of adjuvant TRZ administration on weight, total fat mass, and lean body mass in patients with a history of gastric bypass (Aim 1). Second, the investigators aim to investigate the frequency and severity of GI discomfort associated with TRZ utilizing a validated patient reported outcome questionnaire, and they will investigate the impact of TRZ on GI motility in patients with prior Gastric Bypass (Aim 2).

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37209
    United States

    Site Not Available

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