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Atrial Fibrillation (AF)MOTIVE-AFNCT07897305

Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients

A study testing Mazdutide and Conventional treatment in people with Atrial Fibrillation (AF) and Ablation Treatment, run by Beijing Anzhen Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, open-label, superiority randomized controlled trial enrolling adult patients aged 18 to 75 years. All participants have abdominal obesity (BMI ≥ 28 kg/m² with specific waist circumference standards) and non-valvular atrial fibrillation, and have successfully regained normal heart rhythm after… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Mazdutide and Conventional treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteChina
Study dates
25 Oct 2026to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-75 years (inclusive);
  • BMI ≥ 28 kg/m², with waist circumference ≥ 90 cm for male subjects and ≥ 85 cm for female subjects;
  • Patients with non-valvular atrial fibrillation (AF) undergoing their first AF catheter ablation and maintaining sinus rhythm within 24 hours post-ablation;
  • Anteroposterior diameter of the left atrium (excluding transverse and superoinferior diameters) measured from the parasternal long-axis view on echocardiography < 55 mm;
  • Agree to randomization as specified in this study and be able to complete follow-up assessments as required.

Who cannot join

  • ### Surgery-related
  • AF caused by reversible etiologies;
  • Left ventricular ejection fraction (LVEF) < 30 % on echocardiography;
  • Unstable angina, acute myocardial infarction, or percutaneous coronary intervention (PCI) within the preceding 1 month;
  • Patients with severe coronary artery stenosis without prior PCI;
  • Stroke, transient ischemic attack (TIA), intracerebral hemorrhage, or any embolic event within the preceding 1 month;
Show all 43Show fewer
  • Severe congenital heart disease, such as tetralogy of Fallot, corrected transposition of the great arteries, etc.;
  • Hypertrophic cardiomyopathy;
  • Moderate or greater aortic stenosis, moderate or greater mitral stenosis;
  • Severe hepatic dysfunction (Child-Pugh Class 3), renal insufficiency (eGFR < 30 mL/min/1.73 m²), or a history of renal dialysis, kidney transplantation, or nephrectomy;
  • Prior cardiac surgery, including coronary artery bypass grafting, mechanical or bioprosthetic valve replacement, etc.;
  • Post-implantation of intracardiac devices, such as pacemaker implantation, left atrial appendage closure, patent foramen ovale closure, atrial septal defect transcatheter closure, etc.;
  • Contraindications to anticoagulant therapy;
  • Presence of an inferior vena cava filter, or contraindications to right- or left-heart catheterization (e.g., left atrial thrombus, etc.).
  • ### Medications or treatments received prior to screening
  • Self-reported body weight change > 5 % within 90 days before screening;
  • Use (past or current) of anti-obesity medications within 90 days before screening, including sibutramine hydrochloride, orlistat, phentermine, phenylpropanolamine, mazindol, diethylpropion, lorcaserin, phentermine-topiramate combination, naltrexone-bupropion combination, and GLP-1 receptor agonists (liraglutide, benaglutide, semaglutide, tirzepatide, mazdutide), etc.;
  • Use of weight-altering medications within 90 days before screening: systemic corticosteroids (intravenous, oral, or intra-articular administration), tricyclic antidepressants, psychotropic or sedative agents (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts), etc.;
  • Use of weight-modulating Chinese herbal medicines, health supplements, or meal replacements within 90 days before screening.
  • ### Medical history or documented evidence of any of the following disorders
  • Prior bariatric-metabolic surgery or planned bariatric-metabolic surgery within 1 year;
  • Obesity secondary to underlying diseases or medications: e.g., hypercortisolism (Cushing's syndrome), obesity due to pituitary-hypothalamic injury, obesity following dose reduction/discontinuation of anti-obesity drugs, monogenic obesity, etc.;
  • Confirmed type 1 diabetes mellitus;
  • Prior severe hypoglycaemia or recurrent symptomatic hypoglycaemic episodes (≥ 2 events within 6 months before screening);
  • History of retinopathy;
  • Abnormal thyroid function (including TSH ≤ 0.1 mIU/L or ≥ 10 mIU/L) within 7 days before screening, or history of thyroid surgery;
  • Personal or family history of pancreatitis;
  • Personal or family history of medullary thyroid carcinoma;
  • Personal or family history of multiple endocrine neoplasia syndrome type 2;
  • History of malignant neoplasm or malignant tumour in remission;
  • History of moderate-to-severe depression; or history of severe psychiatric disorders including schizophrenia, bipolar disorder, etc.;
  • Prior suicidal ideation or suicidal behaviour;
  • Limb deformity or amputation precluding accurate measurement of height and body weight;
  • Post-procedural 12-lead ECG showing sinus heart rate < 50 beats/min, second- or third-degree atrioventricular block, long-QT syndrome, or QTcF > 450 ms (male), QTcF > 470 ms (female);
  • Contraindications or known hypersensitivity to mazdutide.
  • ### Exclusion by laboratory values at screening
  • Serum calcitonin ≥ 50 ng/L (pg/mL);
  • Fasting triglycerides ≥ 5.64 mmol/L (500 mg/dL);
  • Serum amylase or lipase > 2.0 × upper limit of normal (ULN).
  • ### Other criteria
  • Pregnant or lactating women; subjects (male or female) of child-bearing potential who plan pregnancy within 1 year or decline contraception throughout the study period and for 8 weeks after study completion;
  • Life expectancy < 1 year due to malignancy, severe organ failure, or other conditions;
  • Any other conditions that, in the investigator's judgement, render the subject unsuitable for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing, China.

    Beijing

Other trials in China

About this study

Official title: Efficacy of Mazdutide in Reducing Recurrence After Catheter Ablation in Obese Patients With Atrial Fibrillation: A Multicenter, Superiority, Open-label, Randomized Controlled Trial

This is a multicenter, open-label, superiority randomized controlled trial enrolling adult patients aged 18 to 75 years. All participants have abdominal obesity (BMI ≥ 28 kg/m² with specific waist circumference standards) and non-valvular atrial fibrillation, and have successfully regained normal heart rhythm after their first catheter ablation.

The study aims to compare the efficacy and safety of weekly mazdutide injection with conventional routine care in preventing heart rhythm recurrence within 12 months after ablation (excluding a 3-month early recovery blanking period). A total of 24 months will be spent recruiting participants, followed by a 12-month follow-up period.

Read more

Participants are randomly divided into two groups. The intervention group receives escalating-dose mazdutide subcutaneous injections starting within 48 hours after ablation alongside standard health guidance on diet, exercise and lifestyle. The control group only receives the same routine health guidance without mazdutide treatment.

The primary efficacy endpoint is recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for >30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of any Class I/III antiarrhythmic drugs (AADs).

Being tested
Mazdutide, Conventional treatment
Keywords
atrial dibrillation, Catheter ablation, Obesity, Mazdutide
Medical subject headings
Atrial Fibrillation, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MazdutideDrug

    1. Initiation of mazdutide subcutaneous injection within 48 hours after catheter ablation. Starting dose: 2 mg subcutaneously once weekly using a single-dose pen auto-injector. The initial dose is 2 mg once weekly, increased by 2 mg every 4 weeks during dose escalation, with a maximum dose of 6 mg. The target dose is individualized based on the patient's weight-loss effect. Once the patient achieves a 10% reduction in body weight, the dose is maintained for continued treatment.
    2. Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.
  • Conventional treatmentOther

    Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.

Study groups in NCT07897305
Study groupRoleWhat they receive
Intervention GroupOther1. Initiation of mazdutide subcutaneous injection within 48 hours after catheter ablation. Starting dose: 2 mg subcutaneously once weekly using a single-dose pen auto-injector. The initial dose is 2 mg once weekly, increased by 2 mg every 4 weeks during dose escalation, with a maximum dose of 6 mg. The target dose is individualized based on the patient's weight-loss effect. Once the patient achieves a 10% reduction in body weight, the dose is maintained for continued treatment. 2. Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.
Receives: Drug: Mazdutide
Control GroupOtherPatients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.
Receives: Other: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of atrial arrhythmias at 12 months after a single ablation procedure without the use of any Class I/III antiarrhythmic drugs (AADs).

    Recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for >30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of any Class I/III antiarrhythmic drugs (AADs).

    Measured: From enrollment to the end of treatment at 52 weeks

  2. Composite serious adverse events (SAEs) occurring during the perioperative period and follow-up period.

    1. follow-up period, including cardiac tamponade/cardiac perforation, acute cerebrovascular events, acute coronary syndrome, pericarditis, acute kidney injury, third-degree atrioventricular block, serious bleeding events, atrial-esophageal fistula, pericardial-esophageal fistula, pulmonary vein stenosis, death, etc.;
    2. Incidence of mazdutide-related adverse reactions, such as nausea/vomiting/diarrhea/abdominal pain, elevated serum calcitonin, elevated pancreatic enzymes, severe hypoglycemia, arrhythmia or conduction system disorders, severe liver function abnormality, severe renal function abnormality, thyroid C-cell hyperplasia or thyroid carcinoma, cholelithiasis, acute cholecystitis, cholecystectomy, severe hypersensitivity reactions, etc.

    Measured: From enrollment to the end of treatment at 52 weeks

Secondary outcomes (9)
  1. Recurrence of atrial arrhythmias at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).

    Recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) at 12 months after a single ablation procedure (after a 3-month blanking period), with or without the use of Class I/III AADs;

    Measured: From enrollment to the end of treatment at 52 weeks

  2. Recurrence of AF at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).

    Recurrence of AF recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for >30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of Class I/III AADs;

    Measured: From enrollment to the end of treatment at 52 weeks

  3. Recurrence of AT or AFL at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).

    Recurrence of atrial flutter or atrial tachycardia recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for >30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of Class I/III AADs;

    Measured: From enrollment to the end of treatment at 52 weeks

  4. Recurrence of atrial arrhythmias after single or multiple ablations during the 12-month follow-up

    Recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) after single or multiple ablations during the 12-month follow-up, with or without the use of Class I/III AADs;

    Measured: From enrollment to the end of treatment at 52 weeks"

  5. AF burden

    AF burden (% time) measured at the 12-month follow-up;

    Measured: From enrollment to the end of treatment at 52 weeks

  6. Body weight

    Changes in body weight in kilograms from baseline to the 12-month follow-up;

    Measured: From enrollment to the end of treatment at 52 weeks

  7. Apnea-Hypopnea Index

    Changes in Apnea-Hypopnea Index (AHI) from baseline to the 12-month follow-up;

    Measured: From enrollment to the end of treatment at 52 weeks

  8. Change in Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) Score From Baseline to 12 Months

    The Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire will be used to assess quality of life. The AFEQT total score ranges from 0 to 120, with higher scores indicating better quality of life. Changes from baseline to the 12-month (52-week) follow-up will be reported.

    Measured: From enrollment to the end of treatment at 52 weeks

  9. Cardiovascular-related hospitalizations

    Incidence of cardiovascular-related hospitalizations during the 12-month follow-up;

    Measured: From enrollment to the end of treatment at 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start25 Oct 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897305
Sponsor's protocol ID
Approval No. (2026)-Keluenshen
Acronym
MOTIVE-AF
Status last verified
Sep 2026
First submitted
30 Sep 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mazdutide and Conventional treatment in people with Atrial Fibrillation (AF) and Ablation Treatment, run by Beijing Anzhen Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Deyong Long (+8613522959166, dragon2008@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of atrial arrhythmias at 12 months after a single ablation procedure without the use of any Class I/III antiarrhythmic drugs (AADs). (time frame: From enrollment to the end of treatment at 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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