Active not recruitingPHASE3INTERVENTIONAL

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

The ZEUS study is looking into whether a new medication called ziltivekimab can help reduce the chances of serious heart problems, like heart attacks and strokes. This study focuses on individuals who already have heart disease, long-term kidney disease, and signs of inflammation in their body. Participants will be randomly assigned to receive either ziltivekimab or a placebo, which is an inactive substance, to compare their effects. Ziltivekimab is currently an experimental drug, meaning it's not yet available as a prescribed medicine. The aim is to understand if this new treatment could offer a protective benefit against future cardiovascular events for this specific group of patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

6,200

Start

30 Aug 2021

Estimated completion

09 Jun 2026

Cardiovascular Risk Chronic Kidney Disease Inflammation

What is this study about?

This research study, called ZEUS, is designed to investigate a new medication named ziltivekimab. The main goal is to find out if this drug can help reduce the risk of future heart problems, such as heart attacks and strokes, in people who have a combination of existing heart disease, ongoing kidney disease, and signs of inflammation. Inflammation is a natural response by your body, but long-term inflammation can sometimes contribute to health issues.

Currently, ziltivekimab is an investigational medicine, which means it hasn't been approved for use by doctors anywhere in the world and isn't available for prescription. This study is crucial for understanding whether it is a safe and effective treatment. We know that conditions like heart disease and kidney disease can increase your risk of serious cardiovascular events, and this study hopes to find a new way to help protect people.

Participants in the study will be randomly assigned to receive either ziltivekimab or a 'placebo'. A placebo is a dummy treatment that looks just like the study drug but contains no active medicine. This method helps researchers fairly compare the effects of the active drug against no treatment, ensuring any observed benefits are truly due to ziltivekimab. Your chances of receiving either the active drug or the placebo are equal.

Key takeaways

A study for people with heart disease, kidney disease, and inflammation.
Investigating a new drug, ziltivekimab, to reduce heart attacks and strokes.
Participants will receive either the study drug or a placebo.
Involves monthly injections, up to 20 clinic visits, and lasts up to 4 years.
Ziltivekimab is an experimental drug, not yet medically approved.

Who may be eligible?

To join the study, you would need to be an adult aged 18 or older. You must also have long-term kidney disease. This is typically measured by how well your kidneys are filtering your blood (eGFR) or by certain levels in your urine.

You also need to show signs of inflammation in your body, which will be checked with a blood test. Additionally, you must have existing heart disease affecting your heart, brain, or legs, such as a history of heart attack, stroke, or problems with blood flow in your limbs.

There are also reasons why someone might not be able to join. For example, if you have an active infection, or if you've recently had a heart attack, stroke, or been hospitalised for heart failure that isn’t stable. Women cannot take part if they are pregnant, breastfeeding, or planning to become pregnant during the study.

Quick self-check

Are you an adult aged 18 or older?
Do you have chronic kidney disease?
Do you have signs of inflammation (measured by a blood test)?
Do you have existing heart or blood vessel disease (e.g., history of heart attack, stroke, or circulation issues)?
Are you able to attend regular clinic visits and self-inject monthly?
Are you a woman who is not pregnant, breastfeeding, or planning pregnancy during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study medicine (either ziltivekimab or placebo) as an injection under your skin, which you would do yourself once a month using a pre-filled syringe. The study is expected to last for up to four years.

Over this period, you would attend up to 20 clinic visits. At most of these visits, you'll need to provide blood and urine samples for testing. Your heart health will also be regularly monitored using special tests called echocardiography (which uses sound waves to create pictures of your heart) and electrocardiograms (ECGs, which record the electrical activity of your heart).

It's important to remember that if you are a woman, you cannot participate if you are pregnant, breastfeeding, or planning to get pregnant during the study period.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing a new treatment before it is widely available, which could help your health. However, like all medicines, ziltivekimab may have side effects, some of which we might not yet fully know, and there's no guarantee the treatment will be effective for you. There is always a risk that the study drug might not work or could cause unexpected side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1065)

Uni of Alabama at Birmingham
Birmingham, United States
Chambliss Clinical Trials LLC
Montgomery, United States
Lenzmeier Fam Med CCT Research
Glendale, United States
Aventiv Research Inc.
Mesa, United States
Univ of Arkansas Med Sciences
Little Rock, United States
Unity Health-Searcy Medical Center
Searcy, United States
National Heart Institute Cal
Beverly Hills, United States
California Inst Of Renal Res
Chula Vista, United States
California Institute of Renal Research #10
Chula Vista, United States
Valley Clinical Trials
Covina, United States
Valiance Clinical Research
Huntington Park, United States
Scripps Wht Diab Inst La Jolla
La Jolla, United States

+1053 more sites — see the official record for the full list.

Common questions

What is ziltivekimab?

Ziltivekimab is an experimental drug, meaning it's still being tested and is not yet approved as a medicine doctors can prescribe.

How will I take the study medicine?

The study medicine is given as an injection under the skin once a month, using a pre-filled syringe that you would administer yourself.

How long will the study last?

The study is expected to last for up to four years, with regular visits to the clinic.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects fairly.

Can pregnant women participate?

No, women who are pregnant, breastfeeding, or planning to become pregnant during the study cannot take part.