What this trial means for you
This study is by invitation only — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Tirzepatide for severe obesity, obesity, bmi greater than 30.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: 1. Subject must be able to understand and provide informed consent. 2. BMI \> 30 12 months after bariatric surgery. 3. Age \> 25 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 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 As this 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 multiple endocrine neoplasia syndrome type 2 9. Pregnancy by urine testing, current lactation, or plans to become pregnant during the 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 skin cancer) in the past 5 years. 14. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism. 15. 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. 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 sites by state
Tennessee
- Vanderbilt University Medical Center — Nashville
View the official record on ClinicalTrials.gov →
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