RecruitingPhase 2NCT06802081

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

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

Sponsor

The Cleveland Clinic

Enrollment

100 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Atrial Fibrillation

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tirzepatide — a weight-loss medication already used for diabetes and obesity — can help reduce weight and improve symptoms in people who have both atrial fibrillation (an irregular heartbeat) and excess weight. **You may be eligible if...** - You are between 18 and 80 years old - You have a BMI between 27 and 60 - You have symptomatic atrial fibrillation (paroxysmal or persistent), confirmed by ECG or heart monitor - You are currently in normal heart rhythm - Your diabetes medications (if any) have been stable for at least 3 months - Your HbA1c (blood sugar control measure) is 10% or below **You may NOT be eligible if...** - You have a history of pancreatitis or thyroid cancer - You are already taking tirzepatide or similar GLP-1/GIP drugs - You have Class IV heart failure or recent heart attack - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week12 (10mg) as tolerated.

DRUGPlacebo

Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg).