In short
Clinical trials are investigating Ziltivekimab in several heart and blood vessel conditions. These studies look at whether it can improve outcomes such as heart failure events, major cardiovascular events, and artery inflammation in people with inflammation, chronic kidney disease, or recent heart attack.
Key points
- Ziltivekimab is being studied in several authorised clinical trials for heart failure, cardiovascular disease, coronary artery disease, and acute myocardial infarction. Most of the studies are Phase 3 trials, and one is a Phase 4 trial. The target populations include people with systemic inflammation, chronic kidney disease, and different forms of heart attack. The main goals are to see whether Ziltivekimab can reduce serious heart and blood vessel events, improve heart failure symptoms, and lower artery inflammation. Trial sizes range from very small studies to very large studies with thousands of participants.
Clinical trial overview
Ziltivekimab is being studied in multiple interventional trials, which means the researchers give a treatment and compare it with a control such as placebo. The available studies are all authorised and are testing whether Ziltivekimab can improve outcomes in people with heart and blood vessel disease, often when inflammation is also present.
Most of the trials are Phase 3 studies, which are larger studies meant to test how well a treatment works in real patient groups. One smaller study, SPIDER, is a Phase 4 trial, which usually means the treatment is being studied after it has already reached later-stage use in research.
Heart failure studies
Two trials focus on heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), together with systemic inflammation. HFmrEF means the heart pumps a slightly lower amount of blood than normal, while HFpEF means the pumping strength looks preserved but the heart does not fill or relax normally.
The HERMES study (NCT05636176) is a Phase 3 trial with 5,598 participants and compares Ziltivekimab with placebo, both added to standard care. Its main goal is to see whether treatment lowers the risk of cardiovascular death, heart failure hospitalisation, or an urgent heart failure visit.
The ATHENA study (2023-506988-34-00) is also Phase 3 and includes 680 participants. It looks at whether Ziltivekimab improves heart failure symptoms and physical function, using the KCCQ clinical summary score, which is a patient questionnaire about how heart failure affects daily life.
Cardiovascular disease and chronic kidney disease
The ZEUS study (2023-506926-35-00) is a Phase 3 trial in 6,200 people with atherosclerotic cardiovascular disease, chronic kidney disease, and systemic inflammation. Atherosclerotic cardiovascular disease means disease caused by buildup of fatty material in the arteries.
This study compares Ziltivekimab with placebo, both given with standard care, to see whether it lowers the risk of major adverse cardiovascular events. The main endpoint is time to first 3-point MACE, which includes cardiovascular death, non-fatal heart attack, and non-fatal stroke.
Coronary artery inflammation study
SPIDER (2024-515893-29-01) is a small Phase 4 study with 40 participants who have coronary artery disease. The trial is designed to study whether 20 weeks of Ziltivekimab can reduce inflammation in the artery wall and also lower systemic inflammatory tone.
Its main measures include changes in target to background ratio on imaging and changes in monocyte activation marker protein expression. In simple terms, this means the study is looking at imaging signs of inflammation and at blood cell markers linked to inflammation.
Myocardial infarction studies
Two trials focus on people who have had a heart attack, also called myocardial infarction. One study, 2024-520364-34-00, includes 367 participants with acute myocardial infarction and tests whether Ziltivekimab can improve percent atheroma volume, which is a measure of plaque burden in the arteries.
The ARTEMIS study (NCT06118281) is a large Phase 3 trial with 8,540 adults who have type 1 acute myocardial infarction, including both STEMI and NSTEMI. STEMI and NSTEMI are two common types of heart attack, and the study starts treatment as early as possible after the event.
ARTEMIS aims to test whether Ziltivekimab reduces the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, non-fatal stroke, and ischaemia-driven coronary revascularisation. Coronary revascularisation means a procedure to restore blood flow in the heart arteries.
Main endpoints and what they measure
A primary outcome or endpoint is the main result the researchers want to measure. In these trials, the endpoints focus on serious clinical events, symptom scores, imaging results, and inflammation markers.
Examples include time to first cardiovascular death, heart failure hospitalisation, urgent heart failure visit, non-fatal heart attack, non-fatal stroke, and ischaemia-driven coronary revascularisation. Other endpoints look at the KCCQ score, percent atheroma volume, target to background ratio, and monocyte activation markers.
Who the trials are for
The studies recruit different patient groups, but they all involve people with a high risk of heart and blood vessel problems. Some trials focus on people with heart failure and systemic inflammation, while others include people with chronic kidney disease, coronary artery disease, or a recent heart attack.
Across the studies, the researchers are trying to learn whether Ziltivekimab can reduce serious events and improve important measures of disease activity in these patient groups.