TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Launched by THE CLEVELAND CLINIC · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called TIRzepatide to see if it can help people with obesity and a heart condition called Atrial Fibrillation (AFIB) lose weight and manage their symptoms better. Participants in the study will be randomly assigned to receive either TIRzepatide or a placebo (a treatment that has no active ingredients) for 12 months. The hope is that losing weight with TIRzepatide will lead to improvements in how well their AFIB is controlled and how they feel overall.

To be eligible for the trial, participants must be between 18 and 80 years old, have a body mass index (BMI) over 30, and have documented symptoms of AFIB. They should be in normal heart rhythm at the time of enrollment and have stable diabetes medications if they are diabetic. Participants will need to be able to self-administer the medication and follow the study guidelines. If you or someone you know fits these criteria and is interested, it's important to know that the study is taking place in Northeast Ohio and is currently recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects eligible for inclusion in this study must meet all of the following criteria:
• • 1. Sinus rhythm at randomization
• • 1. Sustained normal sinus rhythm (or)
• • 2. Normal sinus rhythm at office visit
• • 2. Age ≥18 to ≤80 years old
• • 3. BMI \>30 and ≤60 kg/m2
• 4. AFIB criteria:
• • 1. Must be documented by ECG or monitor.
• • 2. Must have symptomatic AFIB (Atrial Fibrillation).
• • 3. In terms of types of AFIB, either paroxysmal AFIB or persistent AFIB.
• • 5. All anti-diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment,
• • 6. HbA1c ≤10% for patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
• • 7. Ability and willingness to give themselves the medication, comply with study requirements and provide written informed consent.
• Exclusion Criteria:
• • Subjects meeting any of the following criteria are not eligible for inclusion in this study.
• • 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