TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation
Recruiting · NCT06802081 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTirzepatide
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Pregnant, breast-feeding or plans to become pregnant
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States