Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for people with obesity and atrial fibrillation. Participants will receive either Tirzepatide or a placebo for a year to see if it helps with weight loss and AFib symptoms.
Are You a Good Fit for This Trial?
Must be takingStable diabetes medications
Rules you outType 1 diabetesPancreatitis
You may be able to join if
I am between 18 and 80 years old
I have a BMI of at least 27
I have been diagnosed with atrial fibrillation
I can follow study requirements and give consent
You may not be able to join if
I have had AFib ablation within the last 6 months
I have severe heart or lung disease
I have been hospitalized for heart problems in the last 6 months
I have a serious organ condition such as advanced cirrhosis
I am currently pregnant or breastfeeding
I have a personal history of pancreatitis
I have a current active cancer
I have issues with alcohol use
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
Subjects eligible for inclusion in this study must meet all of the following criteria:
1. Sinus rhythm at randomization
1. Sustained normal sinus rhythm (or)
2. Normal sinus rhythm at office visit
2. Age ≥18 to ≤80 years old
3. BMI ≥ 27 and ≤60 kg/m2
4. AFIB criteria:
…
Inclusion Criteria:
Subjects eligible for inclusion in this study must meet all of the following criteria:
1. Sinus rhythm at randomization
1. Sustained normal sinus rhythm (or)
2. Normal sinus rhythm at office visit
2. Age ≥18 to ≤80 years old
3. BMI ≥ 27 and ≤60 kg/m2
4. AFIB criteria:
1. Must be documented by ECG or monitor.
2. Must have symptomatic AFIB (Atrial Fibrillation).
3. In terms of types of AFIB, either paroxysmal AFIB or persistent AFIB.
5. All anti-diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment,
6. HbA1c ≤10% for patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
7. 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.
1. AFIB ablation within the last 6 months
2. Planned ablation prior to 3 months post randomization
3. Significant cardiac valvular disease with planned cardiac valve intervention/surgery in the next 12 months
4. Severe uncompensated cardiopulmonary disease
5. New York Heart Association Class III or IV
6. Left ventricular ejection fraction \<35% at the time of screening
7. Hospitalization in the past 6 months for myocardial infarction, unstable angina, stroke, transient ischemic attack, or heart surgery
8. History of solid organ transplant
9. Type 1 diabetes mellitus or auto-immune diabetes
10. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 at screening or on dialysis
11. Advanced and decompensated cirrhosis characterized by: presence of fibrosis stage 4 (cirrhosis) in liver biopsy, ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
12. Hemoglobin less than 9 g/dL
13. Current participation or use of investigational therapy or less than 3 months since participation in any drug or device trial.
14. Liver transaminase level \>300 U/L
15. Subject reports alcohol use of on average \>2 drinks/day
16. Presence of active malignancy (except non-melanoma skin cancer)
17. Life expectancy less than 3 years due to concomitant diseases
18. Major mental health, psychological disorders, or substance abuse disorders that could disqualify the patient from metabolic surgery
19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
20. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months
21. Any personal or family history of pancreatitis or medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2)
22. 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
23. Known hypersensitivity to investigational product due to prior use of GLP-1/DPP4i or GIP/GLP-1
24. Allergy to medical grade tape or adhesive
25. Pregnant, breast-feeding or plans to become pregnant
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.