An interventional study of Mazdutide and Conventional treatment in Atrial Fibrillation (AF), Ablation Treatment and Obesity & Overweight, sponsored by Beijing Anzhen Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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.
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).
3,958 studies on the registry are indexed under Atrial Fibrillation; 934 are open to participants now.
This study's planned enrollment of 700 is above the median of 145 across 2,438 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
### Surgery-related
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
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
Contraindications or known hypersensitivity to mazdutide.
### Exclusion by laboratory values at screening
Serum amylase or lipase > 2.0 × upper limit of normal (ULN).
### Other criteria
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.
Drug: Mazdutide
Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.
Other: Conventional treatment
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.
Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence.
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).
Time frame: From enrollment to the end of treatment at 52 weeks
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.
Time frame: From enrollment to the end of treatment at 52 weeks
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;
Time frame: From enrollment to the end of treatment at 52 weeks
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;
Time frame: From enrollment to the end of treatment at 52 weeks
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;
Time frame: From enrollment to the end of treatment at 52 weeks
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;
Time frame: From enrollment to the end of treatment at 52 weeks"
AF burden
AF burden (% time) measured at the 12-month follow-up;
Time frame: From enrollment to the end of treatment at 52 weeks
Body weight
Changes in body weight in kilograms from baseline to the 12-month follow-up;
Time frame: From enrollment to the end of treatment at 52 weeks
Apnea-Hypopnea Index
Changes in Apnea-Hypopnea Index (AHI) from baseline to the 12-month follow-up;
Time frame: From enrollment to the end of treatment at 52 weeks
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.
Time frame: From enrollment to the end of treatment at 52 weeks
Cardiovascular-related hospitalizations
Incidence of cardiovascular-related hospitalizations during the 12-month follow-up;
Time frame: From enrollment to the end of treatment at 52 weeks
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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