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

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

• Cardiovascular Risk
• Chronic Kidney Disease
• Inflammation

Interventions

DRUG

Ziltivekimab B

Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

DRUG

Ziltivekimab C

Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

DRUG

Placebo (Ziltivekimab B)

Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

DRUG

Placebo (Ziltivekimab C)

Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

Sponsors & Collaborators

• Novo Nordisk A/S

  lead INDUSTRY

Principal Investigators

• Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-30

Primary Completion

2026-06-09

Completion

2026-06-09

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Bulgaria
• Canada
• China
• Croatia
• Czechia
• Denmark
• Germany
• Greece
• Hungary
• India
• Israel
• Italy
• Japan
• Latvia
• Lithuania
• Malaysia
• Mexico
• Netherlands
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations