NCT05021835

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

ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,200 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-08-30
• Primary completion: 2026-06-09
• Completion: 2026-06-09
• First posted: 2021-08-26
• Last updated: 2026-04-13

Locations

1,065 sites across 38 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

Regulatory

• FDA-regulated drug study