Atherosclerotic cardiovascular disease (ASCVD) occurs when fatty plaques, made of cholesterol and inflammatory cells, build up inside the arteries, causing them to narrow or harden and restricting blood flow to vital organs such as the heart and brain. Over time, these plaques can lead to heart attack, angina, stroke, or other serious cardiovascular events, often without early warning signs. ASCVD includes conditions such as coronary heart disease, heart attack, stroke, and peripheral vascular disease.
Cardiovascular disease remains one of Australia's largest health burdens.
1 in 6 Australians, over 4.5 million people, are living with CVD, and it accounts for 1 in 4 deaths nationally, around 120 every day.
Around 600,000 Australian adults are living with coronary heart disease - the most common form of ASCVD. For many people, managing cardiovascular disease alongside excess weight adds further complexity to their long-term health.
This trial is evaluating whether a new once-weekly self-injectable treatment can help reduce the risk of serious cardiovascular events while also supporting weight management in people with established ASCVD, offering a potential new approach for those managing both conditions at the same time.
treatment design
Eligible participants will be randomly assigned to receive either the investigational once-weekly self-injectable treatment or a placebo, with a 50% chance of receiving either. The injection is self-administered once weekly into the thigh, abdomen, or upper arm, with training provided by the clinical team.
Participants continue their normal treatment and care as directed by their doctor throughout the trial. Participants will attend 25 clinic visits at our Sippy Downs clinic over 4 years. All procedures will be explained clearly, and participants can ask questions at any time.