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

VR72411

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). We 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 receive a placebo.

2024-05-01

2025-08-01

2026-01-01

Not yet recruiting

Early phase I

45

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 Criteria: 1. Inability or unwillingness of a subject to give written informed consent or comply with 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 insulin, in the previous 90 days. 5. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery. 6. Personal history of pancreatitis as determined by history. 7. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2 8. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period. 9. Use of systemic glucocorticoids in the past 28 days 10. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history. 11. History of solid organ transplant. 12. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years. 13. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism. 14. Current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements. 15. Screening creatinine elevation with EGFR \< 60 at time of randomization.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2024-03-12