Evaluating Intravenous YN001 Compared to Placebo in Adults Aged 18 to 80 With Coronary Atherosclerosis Receiving Cardiovascular Risk Therapy

What this Trial Is About

Researchers are evaluating the efficacy and safety of intravenously administered YN001 in adults diagnosed with coronary atherosclerosis who are also receiving background therapy for managing cardiovascular risk factors. This multinational, multicenter, phase 2b clinical trial is randomized, double-blind, and placebo-controlled to compare YN001 with placebo in this patient population. Participants will be randomly assigned to receive one of three doses of YN001 or matching placebo intravenously once weekly for 13 weeks. The doses include 40mg, 20mg, or 0mg placebo. The study consists of up to a 12-week screening and baseline period, a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up extending to approximately two years after randomization. During the study, participants will undergo various assessments including imaging to measure changes in coronary non-calcified plaque volume, carotid intima-media thickness, and plaque characteristics at multiple time points. Safety and immunogenicity will be monitored alongside pharmacokinetic analyses. The primary outcome focuses on relative change in coronary NCPV at week 13. Participants will be followed for up to 96 weeks to evaluate major adverse cardiac events and long-term safety.

A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis