TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Exclusion Criteria

• •1. AFIB ablation within the last 6 months
• •2. Planned ablation prior to 3 months post randomization
• •3. Significant cardiac valvular disease with planned cardiac valve intervention/surgery in the next 12 months
• •4. Severe uncompensated cardiopulmonary disease
• •5. New York Heart Association Class III or IV
• •6. Left ventricular ejection fraction \<35% at the time of screening
• •7. Hospitalization in the past 6 months for myocardial infarction, unstable angina, stroke, transient ischemic attack, or heart surgery
• •8. History of solid organ transplant
• •9. Type 1 diabetes mellitus or auto-immune diabetes
• •10. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 at screening or on dialysis
• •11. Advanced and decompensated cirrhosis characterized by: presence of fibrosis stage 4 (cirrhosis) in liver biopsy, ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
• •12. Hemoglobin less than 9 g/dL
• •13. Current participation or use of investigational therapy or less than 3 months since participation in any drug or device trial.
• •14. Liver transaminase level \>300 U/L
• •15. Subject reports alcohol use of on average \>2 drinks/day
• •16. Presence of active malignancy (except non-melanoma skin cancer)
• •17. Life expectancy less than 3 years due to concomitant diseases
• •18. Major mental health, psychological disorders, or substance abuse disorders that could disqualify the patient from metabolic surgery
• •19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
• •20. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months
• •21. Any personal or family history of pancreatitis or medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2)
• •22. Current use or any use within the last 6 months of GLP-1/DPP4i (Glucagon-Like Peptide-1/Dipeptidyl Peptidase-4 inhibitor) or GIP (Gastric Inhibitory Polypeptide)/GLP-1
• •23. Known hypersensitivity to investigational product due to prior use of GLP-1/DPP4i or GIP/GLP-1
• •24. Allergy to medical grade tape or adhesive
• •25. Pregnant, breast-feeding or plans to become pregnant