TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Atrial Fibrillation, Obesity

In brief

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.

Key facts

Study ID: NCT06802081
Run by: The Cleveland Clinic
People needed: 100
Starts: 2025-04-08
Expected to finish: 2027-06-01
Last updated by the study team: 2026-01-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects eligible for inclusion in this study must meet all of the following criteria:
Sinus rhythm at randomization
Sustained normal sinus rhythm (or)
Normal sinus rhythm at office visit
Age ≥18 to ≤80 years old
BMI ≥ 27 and ≤60 kg/m2
AFIB criteria:
Must be documented by ECG or monitor.
Must have symptomatic AFIB (Atrial Fibrillation).
In terms of types of AFIB, either paroxysmal AFIB or persistent AFIB.
All anti-diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment,
HbA1c ≤10% for patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
Ability and willingness to give themselves the medication, comply with study requirements and provide written informed consent.

You may not qualify if…

Subjects meeting any of the following criteria are not eligible for inclusion in this study.
AFIB ablation within the last 6 months
Planned ablation prior to 3 months post randomization
Significant cardiac valvular disease with planned cardiac valve intervention/surgery in the next 12 months
Severe uncompensated cardiopulmonary disease
New York Heart Association Class III or IV
Left ventricular ejection fraction <35% at the time of screening
Hospitalization in the past 6 months for myocardial infarction, unstable angina, stroke, transient ischemic attack, or heart surgery
History of solid organ transplant
Type 1 diabetes mellitus or auto-immune diabetes
Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 at screening or on dialysis
Advanced and decompensated cirrhosis characterized by: presence of fibrosis stage 4 (cirrhosis) in liver biopsy, ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
Hemoglobin less than 9 g/dL
Current participation or use of investigational therapy or less than 3 months since participation in any drug or device trial.
Liver transaminase level >300 U/L
Subject reports alcohol use of on average >2 drinks/day
Presence of active malignancy (except non-melanoma skin cancer)
Life expectancy less than 3 years due to concomitant diseases
Major mental health, psychological disorders, or substance abuse disorders that could disqualify the patient from metabolic surgery
Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months
Any personal or family history of pancreatitis or medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2)
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
Known hypersensitivity to investigational product due to prior use of GLP-1/DPP4i or GIP/GLP-1
Allergy to medical grade tape or adhesive

Where it is running

Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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