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

Conditions

• Cardiovascular Risk
• Chronic Kidney Disease
• Inflammation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ziltivekimab B — DRUG
  Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
• Ziltivekimab C — DRUG
  Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
• Placebo (Ziltivekimab B) — DRUG
  Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.
• Placebo (Ziltivekimab C) — DRUG
  Administered subcutaneously (s.c., under skin) once-monthly added to standard of care.

Study Details

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.

Key Dates

Start date

Aug 30, 2021

Status verified

Apr 2026

Primary completion

Jun 9, 2026

Completion

Jun 9, 2026

Study Design

Enrollment

6,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ziltivekimab
  Participants will receive Ziltivekimab B or Ziltivekimab C subcutaneously once monthly for up to 4 years.
• Placebo Comparator: Placebo
  Participants will receive either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously once monthly for up to 4 years.

Primary Outcome Measure

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 [ Time Frame: From randomisation (month 0) to end-of-study (up to 48 months) ]

Locations (181)

Find similar trials in Birmingham, AL

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