* 4758: Zeus- Effects of ziltivekimab versus placebo on ASCVD
Research type
Research Study
Full title
ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
IRAS ID
300630
Contact name
Robin Choudhury
Contact email
Eudract number
2020-004853-59
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
UTN number, U1111-1259-3422
Duration of Study in the UK
3 years, 11 months, 29 days
Research summary
There is a major unmet medical need to improve the treatment of patients with
atherosclerotic cardiovascular disease, especially those with chronic kidney disease (CKD), and thereby reduce their risk of Cardiovascular events, such as heart attack. Inflammation is an important risk factor in patients with atherosclerotic cardiovascular disease.
The aim of the current study is to test the efficacy of ziltivekimab in
reducing the risk of major adverse cardiovascular events in adult patients with
established cardiovascular disease, chronic kidney disease and inflammation.
Ziltivekimab, a new drug, is a fully human monoclonal antibody directed against the IL-6 ligand. Currently available clinical data show that ziltivekimab once monthly reduces inflammation as measured by high-sensitivity C-reactive protein (hs-CRP), and thereby has the potential to reduce cardiovascular risk.
This trial is planned to be conducted in 32 countries, approximately 500 sites and approximately 6,200 participants will be randomly assigned (1:1) to 15 mg
ziltivekimab or placebo, both administered subcutaneously once-monthly and added to standard of care.
The trial has a double-blinded, placebo-controlled, parallel-group design. The study is event driven; therefore, end-of-study will be scheduled depending on the accumulated number of major adverse cardiovascular events (MACE). The study duration is expected to be up to 48 months (4 years) following randomisation of the first participant. The recruitment period is anticipated to be approximately 18 months. The total study duration for an individual participant is estimated to be approximately 2.5 to 4 years, depending on the date of entry in the trial of the participant.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0189
Date of REC Opinion
26 Jul 2021
REC opinion
Further Information Favourable Opinion