Atrial Fibrillation study: Tirzepatide
Official title TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT06802081
What this study is testing
What is Tirzepatide?
an investigational once‑weekly injectable medicine being studied as a potential treatment for atrial fibrillation in people with obesity is designed to activate both GIP and GLP‑1 receptors, which can affect appetite, blood sugar, and weight
Also referred to as Zepbound.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether tirzepatide helps weight loss and improves atrial fibrillation symptoms.
- Who it's for
- You may be able to join if you have obesity (BMI ≥ 27) and atrial fibrillation.
- What's involved
- You would be randomly assigned, like a coin toss, to tirzepatide or a pretend treatment. You will take the medicine and have check‑ins for a year.
- Time commitment
- The study lasts 12 months with regular visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.