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TIRO-AF

RecruitingPhase 2

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

100

estimated

Study population

Atrial fibrillation, Obesity / overweight

Key I/E criteria

BMI 27-60HbA1c ≤10%

Primary endpoint

AFib burden

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06802081
Org study ID24-228

Timeline

Milestones

Study first posted2025-01-30actual
Study start2025-04-08actual
Last update posted2026-01-13actual
Primary completion2026-12-31estimated
Study completion2027-06-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Atrial fibrillationObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

AFib burden

Time frame:Up to 4 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.