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Monoclonal Antibodies

Ziltivekimab for Cardiovascular Disease (ZEUS Trial)

Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Urinary albumin-to-creatinine ratio (UACR) >= 200 milligrams per gram (mg/g) and eGFR >= 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation)
a) Coronary heart disease defined as at least one of the following: i. Documented history of MI ii. Prior coronary revascularisation procedure iii. greater than or equal to 50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke of atherosclerotic origin ii. Prior carotid artery revascularisation procedure iii. greater than or equal to 50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound.
Must not have
Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2)
Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (month 0) to 2 years (24 months
Awards & highlights

Summary

This trial is to see if ziltivekimab reduces cardiovascular events in people with cardiovascular disease, chronic kidney disease and inflammation. Ziltivekimab is new and not yet approved. Participants will inject themselves with the study medicine monthly for up to 4 years.

Who is the study for?
This trial is for people with both cardiovascular disease and chronic kidney disease, who also have inflammation. They must have a certain level of kidney function or protein in their urine, signs of heart-related artery issues, or peripheral artery disease. Pregnant women or those planning pregnancy are excluded.Check my eligibility
What is being tested?
The study tests if ziltivekimab can prevent heart attacks and strokes better than a placebo in patients with heart and kidney diseases plus inflammation. Participants will inject either the drug or placebo monthly for up to 4 years, with regular clinic visits and cardiovascular assessments.See study design
What are the potential side effects?
As ziltivekimab is new and not yet approved, potential side effects aren't fully known but may include reactions at the injection site, allergic responses, or other unforeseen complications related to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney tests show a high protein level in my urine but my kidneys are still functioning well.
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You have a history of heart disease, such as a heart attack or blocked arteries, or a history of stroke or blocked arteries in the neck.
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I have heart or blood vessel disease.
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I have symptoms of poor blood flow in my legs due to narrowed or blocked arteries.
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I have chronic kidney disease with specific test results.
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I have heart, brain, or leg artery disease proven by tests or procedures.
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My kidney function is reduced but not extremely low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a procedure to improve blood flow to my heart or other areas.
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I haven't had major surgery in the last 60 days and don't plan any soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (month 0) to 2 years (24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomisation (month 0) to 2 years (24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first occurrence of 3-point Major Adverse Cardiovascular Event (MACE), a composite endpoint consisting of: Cardiovascular (CV) death, non-fatal Myocardial Infarction (MI) and non-fatal stroke
Secondary outcome measures
Annual rate of change in eGFR (CKD-EPI) (total eGFR slope)
Change in N-terminal-pro-brain natriuretic peptide ( NT-pro-BNP)
Change in Short Form 36 (SF-36) Physical Component Score (PCS)
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZiltivekimabExperimental Treatment2 Interventions
Participants will receive Ziltivekimab B or Ziltivekimab C subcutaneously once monthly for up to 4 years.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously once monthly for up to 4 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ziltivekimab C
2023
Completed Phase 1
~270
Ziltivekimab B
2023
Completed Phase 1
~270

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cardiovascular risk often target inflammation, a key factor in the development of cardiovascular diseases. Anti-inflammatory agents like ziltivekimab, which target the interleukin-6 (IL-6) pathway, work by reducing inflammation and lowering levels of C-reactive protein (CRP), a marker associated with cardiovascular events. Statins, another common treatment, lower cholesterol levels and also have anti-inflammatory effects. By reducing inflammation and cholesterol, these treatments help prevent the progression of atherosclerosis and reduce the risk of heart attacks and strokes. This is crucial for cardiovascular risk patients as it directly addresses the underlying mechanisms that contribute to cardiovascular events, thereby improving outcomes and survival rates.
Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS). The ACAPS Group.Associations Between Drug Treatments and the Risk of Aneurysmal Subarachnoid Hemorrhage: a Systematic Review and Meta-analysis.Intensive statin therapy in coronary artery disease: is lower cholesterol better and safe?

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,413,536 Total Patients Enrolled
4 Trials studying Cardiovascular Risk
31,618 Patients Enrolled for Cardiovascular Risk
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
38,955 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
111 Previous Clinical Trials
134,369 Total Patients Enrolled
1 Trials studying Cardiovascular Risk
21,504 Patients Enrolled for Cardiovascular Risk

Media Library

Ziltivekimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05021835 — Phase 3
Cardiovascular Risk Research Study Groups: Ziltivekimab, Placebo
Cardiovascular Risk Clinical Trial 2023: Ziltivekimab Highlights & Side Effects. Trial Name: NCT05021835 — Phase 3
Ziltivekimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05021835 — Phase 3
Cardiovascular Risk Patient Testimony for trial: Trial Name: NCT05021835 — Phase 3
~1808 spots leftby Sep 2025