Monoclonal Antibodies

Ziltivekimab for Cardiovascular Risk

Novo Nordisk Investigational Site, Mumbai, Australia

Targeting 3 different conditionsZiltivekimab C +3 morePhase 3RecruitingResearch Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfrom randomisation (month 0) to 2 years (24 months

Awards & highlights

Pivotal Trial

Study 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.

Eligible Conditions

Cardiovascular Risk
Chronic Kidney Disease
Inflammation

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have a history of heart disease, such as a heart attack or surgery to improve blood flow to the heart, or a history of stroke caused by blocked arteries in the brain or surgery to improve blood flow to the carotid artery.

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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,458 Previous Clinical Trials

2,320,747 Total Patients Enrolled

2 Trials studying Cardiovascular Risk

114 Patients Enrolled for Cardiovascular Risk

Clinical Transparency (dept. 1452)Study Director

Novo Nordisk A/S

56 Previous Clinical Trials

38,998 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study Director

Novo Nordisk A/S

69 Previous Clinical Trials

67,528 Total Patients Enrolled

Media Library

Ziltivekimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05021835 — Phase 3

Cardiovascular Risk Research Study Groups: Placebo, Ziltivekimab

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

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