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

A Prospective, Randomized, Open-Label, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Targeted Interleukin-17A (IL-17A) Inhibitor (Secukinumab) on Cardiovascular and Renal Endpoints in Patients With Cardiorenal Metabolic Syndrome Complicated With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Hypertension; Type 2 Diabetes Mellitus; Peripheral Arterial Disease; Chronic Kidney Disease; Atherosclerotic Cardiovascular Disease; Carotid Artery Stenosis; Cardiorenal Metabolic Syndrome
• Intervention / Treatment: Biological: Secukinumab (75 mg); Other: Standard Medical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wen Tang, MD, PhD; Phone Number: +86 13911292690; Email: tanggwen@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 <60 mL/min/1.73 m² (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation);
   2. UACR ≥ 200 mg/g with eGFR ≥ 60 mL/min/1.73 m² and documented albuminuria.

4. Have documented atherosclerotic cardiovascular disease (at least one):

   1. Coronary heart disease: history of myocardial infarction, prior coronary revascularization, or ≥50% major epicardial coronary artery stenosis confirmed by cardiac catheterization or coronary coronary computed tomography angiography (CTA);
   2. Cerebrovascular disease: prior atherosclerotic stroke, prior carotid revascularization, or ≥50% carotid artery stenosis confirmed by imaging;
   3. Symptomatic peripheral artery disease.
5. Able and willing to provide written informed consent.

Exclusion Criteria:

1. Clinical evidence or suspected active infection judged by investigators.
2. History of myocardial infarction, stroke, transient ischemic attack, or hospitalization for unstable angina within 60 days prior to randomization.
3. Planned coronary, carotid, or peripheral artery revascularization at randomization.
4. Major cardiac surgery, non-cardiac major surgery, or major endoscopy within 60 days before randomization, or planned major surgery during the study period.
5. Current use of systemic immunosuppressive agents (glucocorticoids, small-molecule immunosuppressants, biologic DMARDs, anti-tumor drugs).
6. Long-term intermittent hemodialysis or peritoneal dialysis.
7. History or confirmed evidence of active tuberculosis.
8. History of inflammatory bowel disease.
9. Active malignancy or carcinoma in situ within the past 5 years.
10. Uncontrolled hypertension (systolic blood pressure >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 <2 ×10⁹/L or platelet count <120 ×10⁹/L, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) >2.5 × upper limit of normal.
16. HbA1c ≥10% (≥86 mmol/mol).
17. Any disease condition that may endanger subject safety or impair protocol compliance per investigator judgment.
18. Subjects with inadequate standard therapy judged by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secukinumab + Standard Guideline-Directed Therapy	Biological: Secukinumab (75 mg); 75 mg, subcutaneous injection, once every 4 weeks for a total of 12 weeks; Other: Standard Medical Therapy; Standard guideline-directed cardiovascular and renal protective therapy per clinical practice guidelines
Active Comparator: Standard Guideline-Directed Therapy Alone	Other: Standard Medical Therapy; Standard guideline-directed cardiovascular and renal protective therapy per clinical practice guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to First Occurrence of 3-point Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)	From randomization up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first extended MACE composite endpoint	From randomization up to 2 years
Total number of heart failure hospitalizations, urgent heart failure visits or cardiovascular death	From randomization up to 2 years
All-cause mortality	From randomization up to 2 years
Changes in carotid artery stenosis degree	Baseline, Month 6, Month 24
Changes in carotid artery plaque size	Baseline, Month 6, Month 24
Time to composite chronic kidney disease endpoint (sustained eGFR decline ≥30% or kidney failure)	From randomization up to 2 years
Incidence of kidney failure (death due to renal failure, sustained eGFR <15 mL/min/1.73 m², or long-term renal replacement therapy)	From randomization up to 2 years
Changes in UACR	Baseline, Month 6, Month 24
Changes in eGFR	Baseline, Month 6, Month 24
Annual slope of eGFR	Baseline, Month 6, Month 24
Changes in high-sensitivity C-reactive protein (hs-CRP)	Baseline, Month 6, Month 24
Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP)	Baseline, Month 6, Month 24
Number of new-onset atrial fibrillation events	From randomization up to 2 years
Changes in hemoglobin levels	Baseline, Month 6, Month 24

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Carotid Artery Diseases; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2; Peripheral Arterial Disease; Coronary Artery Disease; Renal Insufficiency, Chronic; Atherosclerosis; Carotid Stenosis; secukinumab
• Other Study ID Numbers: M20260376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No