Effect of Secukinumab on Cardiorenal Outcomes in Patients With Cardiorenal Metabolic Syndrome and Atherosclerotic Cardiovascular Disease

This is a prospective, randomized, open-label, parallel-controlled clinical trial to evaluate the efficacy and safety of targeted IL-17A inhibition with secukinumab on cardiovascular and renal endpoints in 100 patients with cardiorenal metabolic syndrome and atherosclerotic cardiovascular disease (ASCVD). Eligible subjects will be randomized 1:1 to receive either secukinumab 75 mg subcutaneous injection every 4 weeks for a total of 12 weeks plus standard guideline-directed medical therapy, or standard medical therapy alone. The primary endpoint is the time to first occurrence of 3-point major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) over a 2-year follow-up period. Key indicators include estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) for renal outcome assessment.

Inclusion Criteria: 1. Age ≥ 18 years at screening. 2. Meet at least one metabolic abnormality: 1. Body mass index ≥ 23 kg/m²; 2. Waist circumference ≥ 80 cm (female) or ≥ 90 cm (male); 3. Fasting glucose 100-124 mg/dL (5.6-6.9 mmol/L) or glycated hemoglobin (HbA1c) 5.7-6.4%; 4. Serum triglycerides ≥ 3.51 mmol/L; 5. Documented hypertension, metabolic syndrome, or diabetes mellitus. 3. Meet at least one diagnostic criterion for chronic kidney disease: 1. eGFR ≥15 and \180 mmHg or diastolic blood pressure \>110 mmHg). 11. Chronic heart failure classified as New York Heart Association (NYHA) Class IV. 12. History of bone marrow or solid organ transplantation, or planned organ transplantation during the study. 13. Known or suspected allergy to secukinumab or related excipients. 14. Pregnant, lactating females, or females of childbearing potential without adequate effective contraception. 15. Absolute neutrophil count \