Phase 2 Study of Intravenous YN001 Added to Evolocumab for Treating Coronary Atherosclerosis in Australia

What this Trial Is About

Researchers are studying the effects of a drug called YN001 on patients with coronary atherosclerosis, a condition where the arteries supplying blood to the heart become blocked. This Phase 2, multicenter study in Australia aims to assess whether YN001, given along with the drug evolocumab, can reduce the amount of plaque in the coronary arteries. The study involves adults diagnosed with coronary atherosclerosis confirmed by coronary computed tomography angiography CCTA. Participants will be randomly assigned to one of two treatment groups, each receiving a different dose of YN001 administered intravenously once a week for 12 weeks. All participants will also receive evolocumab injections every two weeks during the study. The study includes a screening period of up to 41 days, a baseline visit, a treatment and observation period lasting 13 weeks, and a safety follow-up period lasting 14 days after the last dose. During the study, participants will undergo assessments including CCTA scans to measure changes in plaque volume and composition in the coronary arteries from the start of treatment to week 13. Other measurements include carotid artery thickness and fat attenuation index, safety evaluations, and blood tests to monitor drug levels and effects. The total study duration for participants includes screening, treatment, observation, and safety follow-up periods.

YN001-004 in Patients With Coronary Atherosclerosis in Australia