Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06802081

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Led by The Cleveland Clinic · Updated on 2026-01-13

100

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Sustained or normal sinus rhythm at randomization
  • Age between 18 and 80 years old
  • Body mass index (BMI) of 27 to 60 kg/m2
  • Documented symptomatic Atrial Fibrillation (AFIB) by ECG or monitor
  • Types of AFIB include paroxysmal or persistent
  • Stable anti-diabetic medication use for at least 3 months prior to enrollment
  • HbA1c of 10% or less for patients with Type 2 Diabetes Mellitus
  • Ability and willingness to self-administer medication, comply with study requirements, and provide written informed consent
Not Eligible

You will not qualify if you...

  • AFIB ablation within the last 6 months
  • Planned ablation within 3 months after randomization
  • Significant cardiac valve disease requiring surgery within 12 months
  • Severe uncompensated cardiopulmonary disease
  • New York Heart Association Class III or IV heart failure
  • Left ventricular ejection fraction less than 35% at screening
  • Hospitalization in past 6 months for heart attack, unstable angina, stroke, transient ischemic attack, or heart surgery
  • History of solid organ transplant
  • Type 1 diabetes or autoimmune diabetes
  • Estimated Glomerular Filtration Rate (eGFR) less than 30 mL/min/1.73 m2 or dialysis
  • Advanced decompensated liver cirrhosis
  • Hemoglobin less than 9 g/dL
  • Current or recent (within 3 months) participation in other drug or device trials
  • Liver transaminase levels above 300 U/L
  • Average alcohol use over 2 drinks per day
  • Active cancer except non-melanoma skin cancer
  • Life expectancy under 3 years due to other diseases
  • Major mental health or substance abuse disorders
  • Any condition posing undue risk as judged by the investigator
  • Plans to move outside Northeast Ohio within 12 months
  • Personal or family history of pancreatitis, medullary thyroid cancer, or MEN2
  • Use of GLP-1/DPP4i or GIP/GLP-1 drugs within last 6 months
  • Known allergy to investigational drugs or medical tape/adhesives
  • Pregnant, breastfeeding, or planning pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

J

Jeannine M Ramsey, RN, BSN

CONTACT

Y

Yuki Kuramochi, RN, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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