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ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
NCT05021835 · View on ClinicalTrials.gov ↗
Study Summary
This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Conditions Studied
Interventions
- DRUG Ziltivekimab B
- DRUG Ziltivekimab C
- DRUG Placebo (Ziltivekimab B)
- DRUG Placebo (Ziltivekimab C)
Study Locations (20)
California
- National Heart Institute Cal — Beverly Hills
- California Inst Of Renal Res — Chula Vista
- California Institute of Renal Research #10 — Chula Vista
- Valley Clinical Trials — Covina
- Valiance Clinical Research — Huntington Park
- Scripps Wht Diab Inst La Jolla — La Jolla
- Balboa Nephro Med Gr Inc LaMes — La Mesa
- First Valley Medical Group — Lancaster
- VA Loma Linda Hlthcr Sys — Loma Linda
- Pacific Clinical Studies — Los Alamitos
- Angel City Research, Inc. — Los Angeles
- North America Research Institute — Lynwood
- Hoag Medical Group — Newport Beach
- Valley Clinical Trials, Inc. — Northridge
Alabama
- Uni of Alabama at Birmingham — Birmingham
- Chambliss Clinical Trials, LLC — Montgomery
Arizona
- Lenzmeier Fam Med CCT Research — Glendale
- Aventiv Research Inc. — Mesa
Arkansas
- Univ of Arkansas Med Sciences — Little Rock
- Unity Health-Searcy Medical Center — Searcy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,200 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2026-06-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05021835
The ClinicalTrials.gov registry entry for NCT05021835 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Inflammation appearing as the primary indexed condition, and to 4 interventions — of which Ziltivekimab B is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05021835 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05021835 about?
NCT05021835 is a clinical study titled "ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation". This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medic...
What is the current status of trial NCT05021835?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 6,200 participants. The study started on 2021-08-30. Estimated completion is 2026-06-26.
What conditions does trial NCT05021835 study?
This clinical trial studies the following conditions: Inflammation, Chronic Kidney Disease, Cardiovascular Risk. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05021835?
The interventions under investigation include: Ziltivekimab B (DRUG), Ziltivekimab C (DRUG), Placebo (Ziltivekimab B) (DRUG), Placebo (Ziltivekimab C) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05021835?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05021835 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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