NCT06802081 TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation
| NCT ID | NCT06802081 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Cleveland Clinic |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-04-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single center randomized double blind controlled study of patients (BMI ≥ 27 kg/m2) with obesity and Atrial Fibrillation (AFIB) randomized to Tirzepatide vs. placebo. It is expected that the significant weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.
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 ≥ 27 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
Contact & Investigator
Leslie Cho, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06802081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06802081 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06802081 currently recruiting?
Yes, NCT06802081 is actively recruiting participants. Contact the research team at ramseyj8@ccf.org for enrollment information.
Where is the NCT06802081 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06802081 clinical trial?
NCT06802081 is sponsored by The Cleveland Clinic. The principal investigator is Leslie Cho, MD at The Cleveland Clinic. The trial plans to enroll 100 participants.
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