A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction and Elevated Coronary Inflammation Using CCTA

What this Trial Is About

Researchers are studying the effects of orticumab treatment on inflammation in people who have had a heart attack and show increased coronary inflammation as seen on coronary computed tomography angiography (CCTA). This Phase 2 trial aims to compare the impact of orticumab versus placebo on inflammation in coronary arteries, measured using the Fat Attenuation Index (FAI), over a 6-month period. The study focuses on participants with prior myocardial infarction who meet specific inflammation criteria based on CCTA imaging and are on stable cardiovascular treatment. Participants will receive either orticumab or placebo treatment for 24 weeks. There are multiple treatment groups, including high and low doses of both orticumab and placebo. An optional Day 14 sub-study is available where participants can have additional safety assessments and blood tests to measure serum orticumab levels and inflammation biomarkers. Throughout the study, participants are expected to attend all scheduled visits, provide complete medical history, and consult the study doctor before any changes to their usual treatments. During the study, participants will undergo assessments including CCTA scans to measure coronary artery inflammation, blood tests for safety and biomarker analysis, and monitoring for adverse events. The main outcome is the percent change in the mean FAI score in the coronary arteries after 24 weeks of treatment. Secondary outcomes include changes in coronary artery inflammation and CaRi-Heart score. Safety monitoring and adherence to cardiovascular medication regimens will be maintained throughout the trial, which is expected to continue until June 2027.

Focused Orticumab Research for Treating Inflammation in Coronary Arteries