Study of Olpasiran Injection for Reducing Heart Artery Plaque in Adults with Stable Cardiovascular Disease and High Lipoproteina

What this Trial Is About

Researchers are evaluating the effects of olpasiran, compared to a placebo, on the volume of non-calcified plaque in participants with stable atherosclerotic cardiovascular disease and elevated lipoproteina. This Phase 3 trial aims to study how olpasiran impacts coronary artery plaque burden using Coronary Computed Tomography Angiography CCTA. The study is sponsored by Amgen and includes adults aged 35 to 80 years with a history of coronary artery disease and elevated lipoproteina levels. Participants are randomly assigned to receive either olpasiran or placebo administered as a subcutaneous injection every 12 weeks. The trial lasts for 72 weeks during which changes in non-calcified plaque volume will be measured from baseline to week 72. Secondary outcomes include changes in low attenuation plaque volume, total plaque volume, calcified plaque volume, and monitoring of treatment-emergent adverse events up to week 74. Throughout the study, participants will undergo regular assessments including CCTA scans to measure plaque volumes. Safety and tolerability will be closely monitored by tracking adverse events. The primary outcome focuses on the change in non-calcified plaque volume over the 72-week treatment period. Participants can expect scheduled visits for injections and imaging assessments, with the entire trial lasting approximately 18 months.

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial