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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomisation (month 0) to 2 years (24 months
Awards & highlights
ZEUS Trial 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.
ZEUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney tests show a high protein level in my urine but my kidneys are still functioning well.
Select...
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.
Select...
I have heart or blood vessel disease.
Select...
I have symptoms of poor blood flow in my legs due to narrowed or blocked arteries.
Select...
I have chronic kidney disease with specific test results.
Select...
I have heart, brain, or leg artery disease proven by tests or procedures.
Select...
My kidney function is reduced but not extremely low.
ZEUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomisation (month 0) to 2 years (24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomisation (month 0) to 2 years (24 months
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 moreZEUS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZiltivekimabExperimental Treatment2 Interventions
Participants will receive 15 milligrams (mg) of either Ziltivekimab B or Ziltivekimab C subcutaneously using single-use pre-filled DV3430-C1 manual syringe or single-dose DV3430-C3 pen-injector respectively once monthly for up to 4 years.
Group II: PlaceboPlacebo Group2 Interventions
Participants will receive 15 mg of either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously using single-use pre-filled DV3430-C1 manual syringe or single-dose DV3430-C3 pen-injector respectively 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
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,408,868 Total Patients Enrolled
4 Trials studying Cardiovascular Risk
31,618 Patients Enrolled for Cardiovascular Risk
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
38,920 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
133,626 Total Patients Enrolled
1 Trials studying Cardiovascular Risk
21,504 Patients Enrolled for Cardiovascular Risk
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney tests show a high protein level in my urine but my kidneys are still functioning well.I might have an infection, as per my doctor's assessment.Your kidney function, measured using a test called eGFR, is between 15 and 60 mL/min/1.73 m^2.Your blood test shows a high level of a protein called hs-CRP, which is a sign of inflammation.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.I have heart or blood vessel disease.I have not had a heart attack, stroke, or severe chest pain requiring hospitalization in the last 2 months.I have symptoms of poor blood flow in my legs due to narrowed or blocked arteries.Your blood test shows high levels of a protein called C-reactive protein (CRP).I am scheduled for a procedure to improve blood flow to my heart or other areas.I have chronic kidney disease with specific test results.I have heart, brain, or leg artery disease proven by tests or procedures.I haven't had major surgery in the last 60 days and don't plan any soon.My kidney function is reduced but not extremely low.
Research Study Groups:
This trial has the following groups:- Group 1: Ziltivekimab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cardiovascular Risk Patient Testimony for trial: Trial Name: NCT05021835 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the Ziltivekimab FDA status?
"There is already some clinical data affirming Ziltivekimab's efficacy, and thus it has been given a safety score of 3 by our team here at Power."
Answered by AI
Are there different hospitals testing this treatment in North America?
"Currently, this trial is 100% operational at 100 sites. If you are interested in participating, it would be advantageous to select a location near you from the list of 100 total sites. The sites are located in in Hazel Crest, Evansville and Boston among other places."
Answered by AI
Who else is applying?
What state do they live in?
New York
North Carolina
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Tennova Healthcare-Turkey Creek Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
2
0
Why did patients apply to this trial?
Can’t breathe when laying on back. To help others with heart disease. Not satisfied with the results of my current treatment.
PatientReceived no prior treatments
I’m hoping to find a clinical trial to help with my condition. I’m interested in being proactive with my medical conditions.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long will screening visits take? How long is the trial and is there compensation?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Novo Nordisk Investigational Site: < 24 hours
Typically responds via
Email
Average response time
- < 2 Days
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