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Weight-Loss drug tirzepatide takes on heart flutter in new trial

NCT ID NCT06802081

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study at the Cleveland Clinic will test whether the weight-loss drug tirzepatide (Zepbound) can help people with obesity and atrial fibrillation (AFib). About 100 participants will receive weekly injections of tirzepatide or a placebo for up to 12 months. The main goal is to see if weight loss reduces the total time spent in AFib and improves symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tirzepatide (Zepbound)
What this could lead to
If successful, this could show that weight loss with tirzepatide helps control atrial fibrillation symptoms and reduce time spent in AFib.
What could go wrong
This is a small, early-phase trial (100 people) at one center. Results may not apply to everyone, and tirzepatide has side effects like nausea and vomiting. The study is not designed to prove long-term safety or efficacy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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