RECRUITING

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

TIRO-AF: TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Quick Facts

Study Start:2025-04-08

Study Completion:2027-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06802081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Jeannine M Ramsey, RN, BSN

CONTACT

216-559-7942

ramseyj8@ccf.org

Yuki Kuramochi, RN, BSN

CONTACT

216-445-4063

kuramoy@ccf.org

Principal Investigator

Leslie Cho, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Leslie Cho, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-08

Study Completion Date2027-06-01

Study Record Updates

Study Start Date2025-04-08

Study Completion Date2027-06-01

Terms related to this study

Keywords Provided by Researchers

Atrial Fibrillation
Obesity
tirzepatide

Additional Relevant MeSH Terms

Atrial Fibrillation
Obesity