TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

NCT06802081 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-228
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Obesity

Keywords

Atrial Fibrillation; Obesity; tirzepatide

Outcome Measures

Primary Outcomes (1)

• AFib burden

  Percentage total duration of being in AFIB

  Up to 4 weeks

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Participants to inject weekly subcutaneous injections of Tirzepatide starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg) as tolerated.

Drug: Tirzepatide

Control

PLACEBO COMPARATOR

Participants to inject weekly subcutaneous injections of normal saline starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg).

Drug: Placebo

Interventions

Tirzepatide DRUG

Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week12 (10mg) as tolerated.

Also known as: Zepbound

Tirzepatide

Placebo DRUG

Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg).

Also known as: Normal Saline

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify 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
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Obesity

Interventions

Tirzepatide; Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Leslie Cho, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeannine M Ramsey, RN, BSN

CONTACT

216-559-7942; ramseyj8@ccf.org

Yuki Kuramochi, RN, BSN

CONTACT

216-445-4063; kuramoy@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 30, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)