NCT07704190Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- Jul 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Peking University Third Hospital
- NCT number
- NCT07704190
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From Jul 2026 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of myocardial infarction, stroke, transient ischemic attack, or hospitalization for unstable angina within 60 days prior to 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).
- Subjects with inadequate standard therapy judged by investigators.
Other illness
- Clinical evidence or suspected active infection judged by investigators.
- 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.
- Any disease condition that may endanger subject safety or impair protocol compliance per investigator judgment.
Lab values
- 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.
- HbA1c ≥10% (≥86 mmol/mol).
Other
- Planned coronary, carotid, or peripheral artery revascularization at randomization.
- Long-term intermittent hemodialysis or peritoneal dialysis.
- Pregnant, lactating females, or females of childbearing potential without adequate effective contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.