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New treatment option for Atrial Fibrillation
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?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for atrial fibrillation.
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 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.
- 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
- people 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
You likely can't join if
- people 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
See the full eligibility criteria
- people 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.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.