Atherosclerotic cardiovascular disease (ASCVD) is a condition in which plaque, made up of fat, cholesterol, and other substances, builds up inside the artery walls over time, causing them to become thick and hard. As the arteries narrow, blood flow decreases, and the body's organs receive less oxygen. ASCVD often develops without obvious symptoms in the early stages, making it one of the most dangerous and underrecognised cardiovascular conditions.
In Australia,
cardiovascular disease was the underlying cause of 42,300 deaths, around 23% of all deaths, in 2024, with approximately 156 acute coronary events recorded every day. The leading risk factors driving this burden include high blood pressure, poor diet, and high cholesterol. While existing treatments such as statins can reduce the risk of cardiovascular events, ASCVD remains a leading cause of death and disability both in Australia and globally, highlighting an urgent need for more effective therapeutic options.
This trial is evaluating the effectiveness of a new investigational once-daily tablet in reducing atherosclerotic plaque in people living with ASCVD. Cardiac CT Angiography (CCTA) imaging is used at three points throughout the study to directly measure whether the treatment is reducing plaque build-up in the arteries, giving researchers a precise, evidence-based measured picture of its impact.
Eligible participants will be randomly assigned to receive either the investigational tablet or a placebo, with a 75% chance of receiving the active treatment, tested across varying dose levels. The tablet is taken orally once daily at approximately the same time each day.
The trial runs for 58 weeks, with participants attending 9 clinic visits at our Morayfield and South Bank clinics. Cardiac CT Angiography (CCTA) imaging will be performed three times over the course of the study to directly measure changes in arterial plaque. All procedures will be explained clearly, and participants can ask questions at any time.
