Could an arthritis drug shield heart and kidneys in metabolic syndrome?
NCT ID NCT07704190
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study tests whether secukinumab, a drug that blocks inflammation, can reduce the risk of major heart problems and kidney decline in people with cardiorenal metabolic syndrome and hardened arteries. About 100 adults will receive either secukinumab injections plus standard care, or standard care alone, and be followed for two years. The main goal is to see if the drug delays heart attacks, strokes, or heart-related death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- secukinumab, an injectable drug that blocks IL-17A to reduce inflammation
- What this could lead to
- If successful, this could show that targeting inflammation with secukinumab lowers the risk of heart attacks, strokes, and kidney decline in people with metabolic syndrome and heart disease.
- What could go wrong
- This is a small, early-phase trial with only 100 participants, so results may not apply broadly. The drug may not improve outcomes and could have side effects like infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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