Weight-Loss drug tirzepatide may help keep heart rhythm steady after ablation

NCT ID NCT07715929

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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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 Results may not be published yet.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

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Status unknown
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First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This trial tests whether adding tirzepatide (Mounjaro) to a structured lifestyle program reduces the return of atrial fibrillation within a year after catheter ablation in obese patients. About 710 participants with symptomatic AF and a BMI of 28 or higher (or 24 with other risk factors) will receive either tirzepatide injections plus lifestyle changes or lifestyle changes alone. The main goal is to see if the drug lowers the rate of AF, atrial flutter, or atrial tachycardia episodes lasting 30 seconds or more.

What this could mean

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

Active substance
tirzepatide (Mounjaro), a once-weekly injection that targets two gut hormones to promote weight loss and improve metabolism
What this could lead to
If successful, this could offer a new way to prevent atrial fibrillation from coming back after ablation in people with obesity, combining weight-loss medication with lifestyle changes.
What could go wrong
This is a Phase 4 trial, so the drug is already approved for weight loss, but its effect on heart rhythm after ablation is unproven. Side effects like nausea or rare pancreatitis are possible, and the open-label design may introduce bias.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 710 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 75 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: * Age ≥18 years and ≤75 years at the time of screening * Documented symptomatic paroxysmal AF or persistent AF, confirmed by 12-lead ECG, Holter monitoring, or cardiac monitoring device, with documented AF episode duration ≥7 days (for persistent AF) and total AF history duration ≤5 years * Body weight criteria (aligned with NMPA-approved tirzepatide indication) meeting at least one of the following: BMI ≥28.0 kg/m² (obesity threshold per Chinese criteria), OR BMI ≥24.0 kg/m² and \<28.0 kg/m² (overweight per Chinese criteria) with at least one weight-related comorbidity: hypertension, dyslipidemia, type 2 diabetes mellitus (T2DM), obstructive sleep apnea syndrome (OSAS), or atherosclerotic cardiovascular disease (ASCVD) * Failed response to or intolerance of at least one antiarrhythmic drug (AAD), or explicit patient preference for a rhythm control strategy * Undergoing catheter ablation for AF at a participating center, with confirmed successful restoration of sinus rhythm at the end of the procedure (as determined by the operator) * Willing and able to understand the study procedures, provide written informed consent, and comply with all protocol requirements including 12-month follow-up visits * Capable of performing basic physical activity (no absolute contraindication to moderate-intensity aerobic exercise) Exclusion Criteria: Cardiovascular Exclusion Criteria * Long-standing persistent AF: continuous AF duration ≥5 years prior to enrollment * Prior catheter ablation for AF or atrial flutter at any time * Left atrial anteroposterior diameter \>55 mm (by transthoracic echocardiography at screening) * Left ventricular ejection fraction (LVEF) \<35% at screening * NYHA functional class III or IV heart failure * Significant structural heart disease: hypertrophic cardiomyopathy, valvular heart disease requiring intervention, congenital heart disease, myocarditis, or cardiac sarcoidosis * Acute coronary syndrome (ACS), ischemic stroke/TIA, or major cardiac surgery within 6 months prior to screening Tirzepatide-Specific Exclusion Criteria (per NMPA Prescribing Information) * Prior use of any GLP-1 receptor agonist (liraglutide, semaglutide, dulaglutide, exenatide, etc.) or GIP receptor agonist, or known hypersensitivity to tirzepatide or any excipient in the formulation * Personal or family (first-degree relative) history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) * History of acute pancreatitis or chronic pancreatitis, or current symptomatic cholelithiasis or cholecystitis * Type 1 DM * Severe gastrointestinal disease including severe gastroparesis, inflammatory bowel disease, or any condition that would substantially impair gastrointestinal motility or absorption General Exclusion Criteria * Use of any weight-loss medication (orlistat, phentermine, naltrexone/bupropion, or other anti-obesity agents) or participation in any weight-loss pharmacotherapy clinical trial within 3 months prior to screening * Severe hepatic insufficiency (Child-Pugh class C) or severe renal insufficiency (eGFR \<15 mL/min/1.73 m²) * Active malignancy (receiving systemic anti-cancer treatment or with life expectancy \<2 years due to malignancy) * Pregnancy, breastfeeding, or women of childbearing potential who are unwilling to use highly effective contraception throughout the study and for ≥1 month after the last dose of tirzepatide * Severe psychiatric disorder (schizophrenia, bipolar disorder, severe major depressive disorder) that would impair ability to comply with study procedures * Known allergy or sensitivity to adhesive patch materials (relevant to ECG monitoring patch components) * Any other condition that, in the opinion of the investigator, would make participation inadvisable or compromise the safety of the participant or the integrity of the study

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Conditions

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