{ "data": { "asOf": "2026-10-30T22:25:43.187Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07897305", "title": "Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients", "scientificTitle": "Efficacy of Mazdutide in Reducing Recurrence After Catheter Ablation in Obese Patients With Atrial Fibrillation: A Multicenter, Superiority, Open-label, Randomized Controlled Trial", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Atrial Fibrillation (AF)", "Ablation Treatment", "Obesity & Overweight", "Mazdutide" ], "interventions": [ { "name": "Mazdutide", "type": "DRUG", "description": "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.\n2. Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence." }, { "name": "Conventional treatment", "type": "OTHER", "description": "Patients receive health guidance before discharge, including diet, exercise, smoking cessation, and alcohol abstinence." } ], "sponsor": { "name": "Beijing Anzhen Hospital", "type": "OTHER" }, "locations": [ { "city": "Beijing", "country": "China", "facility": "Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing, China." } ], "outcomes": { "other": [], "primary": [ "Recurrence of atrial arrhythmias at 12 months after a single ablation procedure without the use of any Class I/III antiarrhythmic drugs (AADs).", "Composite serious adverse events (SAEs) occurring during the perioperative period and follow-up period." ], "secondary": [ "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 AF at 12 months after a single ablation procedure with or without the use of any Class I/III antiarrhythmic drugs (AADs).", "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 arrhythmias after single or multiple ablations during the 12-month follow-up", "AF burden", "Body weight", "Apnea-Hypopnea Index", "Change in Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) Score From Baseline to 12 Months", "Cardiovascular-related hospitalizations" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Aged 18-75 years (inclusive);\n2. BMI ≥ 28 kg/m², with waist circumference ≥ 90 cm for male subjects and ≥ 85 cm for female subjects;\n3. Patients with non-valvular atrial fibrillation (AF) undergoing their first AF catheter ablation and maintaining sinus rhythm within 24 hours post-ablation;\n4. Anteroposterior diameter of the left atrium (excluding transverse and superoinferior diameters) measured from the parasternal long-axis view on echocardiography \\< 55 mm;\n5. Agree to randomization as specified in this study and be able to complete follow-up assessments as required.\n\nExclusion Criteria:\n\n\\### Surgery-related\n\n1. AF caused by reversible etiologies;\n2. Left ventricular ejection fraction (LVEF) \\< 30 % on echocardiography;\n3. Unstable angina, acute myocardial infarction, or percutaneous coronary intervention (PCI) within the preceding 1 month;\n4. Patients with severe coronary artery stenosis without prior PCI;\n5. Stroke, transient ischemic attack (TIA), intracerebral hemorrhage, or any embolic event within the preceding 1 month;\n6. Severe congenital heart disease, such as tetralogy of Fallot, corrected transposition of the great arteries, etc.;\n7. Hypertrophic cardiomyopathy;\n8. Moderate or greater aortic stenosis, moderate or greater mitral stenosis;\n9. 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;\n10. Prior cardiac surgery, including coronary artery bypass grafting, mechanical or bioprosthetic valve replacement, etc.;\n11. Post-implantation of intracardiac devices, such as pacemaker implantation, left atrial appendage closure, patent foramen ovale closure, atrial septal defect transcatheter closure, etc.;\n12. Contraindications to anticoagulant therapy;\n13. Presence of an inferior vena cava filter, or contraindications to right- or left-heart catheterization (e.g., left atrial thrombus, etc.).\n\n \\### Medications or treatments received prior to screening\n14. Self-reported body weight change \\> 5 % within 90 days before screening;\n15. 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.;\n16. 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.;\n17. Use of weight-modulating Chinese herbal medicines, health supplements, or meal replacements within 90 days before screening.\n\n \\### Medical history or documented evidence of any of the following disorders\n18. Prior bariatric-metabolic surgery or planned bariatric-metabolic surgery within 1 year;\n19. 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.;\n20. Confirmed type 1 diabetes mellitus;\n21. Prior severe hypoglycaemia or recurrent symptomatic hypoglycaemic episodes (≥ 2 events within 6 months before screening);\n22. History of retinopathy;\n23. Abnormal thyroid function (including TSH ≤ 0.1 mIU/L or ≥ 10 mIU/L) within 7 days before screening, or history of thyroid surgery;\n24. Personal or family history of pancreatitis;\n25. Personal or family history of medullary thyroid carcinoma;\n26. Personal or family history of multiple endocrine neoplasia syndrome type 2;\n27. History of malignant neoplasm or malignant tumour in remission;\n28. History of moderate-to-severe depression; or history of severe psychiatric disorders including schizophrenia, bipolar disorder, etc.;\n29. Prior suicidal ideation or suicidal behaviour;\n30. Limb deformity or amputation precluding accurate measurement of height and body weight;\n31. 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);\n32. Contraindications or known hypersensitivity to mazdutide.\n\n \\### Exclusion by laboratory values at screening\n33. Serum calcitonin ≥ 50 ng/L (pg/mL);\n34. Fasting triglycerides ≥ 5.64 mmol/L (500 mg/dL);\n35. Serum amylase or lipase \\> 2.0 × upper limit of normal (ULN).\n\n \\### Other criteria\n36. 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;\n37. Life expectancy \\< 1 year due to malignancy, severe organ failure, or other conditions;\n38. 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