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

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
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.


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.

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

Who else is applying?

What state do they live in?
New York
North Carolina
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

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.
I’m hoping to find a clinical trial to help with my condition. I’m interested in being proactive with my medical conditions.

What questions have other patients asked about this trial?

How long will screening visits take? How long is the trial and is there compensation?

How responsive is this trial?

Typically responds via
Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
~2971 spots leftby Sep 2025