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AzTrials

Cardiorenal Metabolic SyndromePhase 4NCT07704190

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

A Phase 4 study testing Secukinumab (75 mg) and Standard Medical Therapy in people with Cardiorenal Metabolic Syndrome and Atherosclerotic Cardiovascular Disease, run by Peking University Third Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Secukinumab (75 mg) and Standard Medical Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
15 Jul 2026to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • HbA1c ≥10% (≥86 mmol/mol).
  • Any disease condition that may endanger subject safety or impair protocol compliance per investigator judgment.
  • Subjects with inadequate standard therapy judged by investigators.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wen Tang, MD, PhD contact

+86 13911292690

tanggwen@126.com

About this study

Official title: 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.

Being tested
Secukinumab (75 mg), Standard Medical Therapy
Medical subject headings
Atherosclerosis, Renal Insufficiency, Chronic, Coronary Artery Disease, Hypertension, Diabetes Mellitus, Type 2, Peripheral Arterial Disease, Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secukinumab (75 mg)Biological

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

  • Standard Medical TherapyOther

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

Study groups in NCT07704190
Study groupRoleWhat they receive
Secukinumab + Standard Guideline-Directed TherapyExperimentalNot described
Receives: Biological: Secukinumab (75 mg); Other: Standard Medical Therapy
Standard Guideline-Directed Therapy AloneActive comparatorNot described
Receives: Other: Standard Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Occurrence of 3-point Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)

    Measured: From randomization up to 2 years

Secondary outcomes (14)

  1. Time to first extended MACE composite endpoint

    Measured: From randomization up to 2 years

  2. Total number of heart failure hospitalizations, urgent heart failure visits or cardiovascular death

    Measured: From randomization up to 2 years

  3. All-cause mortality

    Measured: From randomization up to 2 years

  4. Changes in carotid artery stenosis degree

    Measured: Baseline, Month 6, Month 24

  5. Changes in carotid artery plaque size

    Measured: Baseline, Month 6, Month 24

  6. Time to composite chronic kidney disease endpoint (sustained eGFR decline ≥30% or kidney failure)

    Measured: From randomization up to 2 years

  7. Incidence of kidney failure (death due to renal failure, sustained eGFR <15 mL/min/1.73 m², or long-term renal replacement therapy)

    Measured: From randomization up to 2 years

  8. Changes in UACR

    Measured: Baseline, Month 6, Month 24

  9. Changes in eGFR

    Measured: Baseline, Month 6, Month 24

  10. Annual slope of eGFR

    Measured: Baseline, Month 6, Month 24

  11. Changes in high-sensitivity C-reactive protein (hs-CRP)

    Measured: Baseline, Month 6, Month 24

  12. Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

    Measured: Baseline, Month 6, Month 24

  13. Number of new-onset atrial fibrillation events

    Measured: From randomization up to 2 years

  14. Changes in hemoglobin levels

    Measured: Baseline, Month 6, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704190
Sponsor's protocol ID
M20260376
Status last verified
Jun 2026
First submitted
6 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Secukinumab (75 mg) and Standard Medical Therapy in people with Cardiorenal Metabolic Syndrome and Atherosclerotic Cardiovascular Disease, run by Peking University Third Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen Tang, MD, PhD (+86 13911292690, tanggwen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Occurrence of 3-point Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) (time frame: From randomization up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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