Using Tirzepatide to treat obesity in patients with Atrial Fibrillation

TIRO-AF: TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

This study is testing if the weight loss medication Tirzepatide can help people with obesity and Atrial Fibrillation feel better and manage their symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06802081 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized double-blind controlled study focusing on patients with obesity and Atrial Fibrillation (AFIB). Participants with a BMI greater than 30 kg/m2 will be assigned to receive either Tirzepatide or a placebo for 12 months. The study aims to evaluate whether significant weight loss from Tirzepatide can improve the management and symptoms of AFIB. Patients will be monitored for AFIB burden using FDA-approved event monitors, while also receiving standard care for their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a BMI over 30 and documented symptomatic Atrial Fibrillation.

Not a fit: Patients who have undergone AFIB ablation within the last 6 months or have planned ablation procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to significant weight loss and improved management of Atrial Fibrillation symptoms for patients.

How similar studies have performed: Previous studies have indicated that weight loss can positively impact Atrial Fibrillation management, suggesting potential success for this approach.

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Leslie Cho, MD — The Cleveland Clinic
• Study coordinator: Jeannine M Ramsey, RN, BSN

Conditions Atrial Fibrillation; Obesity; tirzepatide