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

NCT07704190 | Not Yet Recruiting Phase 4

• 1 other identifier: M20260376
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiorenal Metabolic Syndrome; Atherosclerotic Cardiovascular Disease; Chronic Kidney Disease; Coronary Artery Disease; Hypertension; Type 2 Diabetes Mellitus; Peripheral Arterial Disease; Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

Study Arms (2)

Secukinumab + Standard Guideline-Directed Therapy

EXPERIMENTAL

Biological: Secukinumab (75 mg); Other: Standard Medical Therapy

Standard Guideline-Directed Therapy Alone

ACTIVE COMPARATOR

Other: Standard Medical Therapy

Interventions

Secukinumab (75 mg) BIOLOGICAL

75 mg, subcutaneous injection, once every 4 weeks for a total of 12 weeks

Secukinumab + Standard Guideline-Directed Therapy

Standard Medical Therapy OTHER

Standard guideline-directed cardiovascular and renal protective therapy per clinical practice guidelines

Secukinumab + Standard Guideline-Directed Therapy; Standard Guideline-Directed Therapy Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at screening.
• Meet at least one metabolic abnormality:
• Body mass index ≥ 23 kg/m²;
• Waist circumference ≥ 80 cm (female) or ≥ 90 cm (male);
• Fasting glucose 100-124 mg/dL (5.6-6.9 mmol/L) or glycated hemoglobin (HbA1c) 5.7-6.4%;
• Serum triglycerides ≥ 3.51 mmol/L;
• Documented hypertension, metabolic syndrome, or diabetes mellitus.
• Meet at least one diagnostic criterion for chronic kidney disease:
• eGFR ≥15 and \<60 mL/min/1.73 m² (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] creatinine equation);
• UACR ≥ 200 mg/g with eGFR ≥ 60 mL/min/1.73 m² and documented albuminuria.
• Have documented atherosclerotic cardiovascular disease (at least one):
• 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);
• Cerebrovascular disease: prior atherosclerotic stroke, prior carotid revascularization, or ≥50% carotid artery stenosis confirmed by imaging;
• Symptomatic peripheral artery disease.
• Able and willing to provide written informed consent.

You may not qualify if:

• Clinical evidence or suspected active infection judged by investigators.
• History of myocardial infarction, stroke, transient ischemic attack, or hospitalization for unstable angina within 60 days prior to randomization.
• Planned coronary, carotid, or peripheral artery revascularization at randomization.
• Major cardiac surgery, non-cardiac major surgery, or major endoscopy within 60 days before randomization, or planned major surgery during the study period.
• Current use of systemic immunosuppressive agents (glucocorticoids, small-molecule immunosuppressants, biologic DMARDs, anti-tumor drugs).
• Long-term intermittent hemodialysis or peritoneal dialysis.
• History or confirmed evidence of active tuberculosis.
• History of inflammatory bowel disease.
• Active malignancy or carcinoma in situ within the past 5 years.
• Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg).
• Chronic heart failure classified as New York Heart Association (NYHA) Class IV.
• History of bone marrow or solid organ transplantation, or planned organ transplantation during the study.
• Known or suspected allergy to secukinumab or related excipients.
• Pregnant, lactating females, or females of childbearing potential without adequate effective contraception.
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Atherosclerosis; Renal Insufficiency, Chronic; Coronary Artery Disease; Hypertension; Diabetes Mellitus, Type 2; Peripheral Arterial Disease; Carotid Stenosis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Vascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Wen Tang, MD, PhD

CONTACT

+86 13911292690; tanggwen@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share