Atherosclerotic cardiovascular disease (ASCVD), including coronary artery disease, stroke, and peripheral arterial disease, remains one of the leading causes of death and disability in Australia. It is caused by the build-up of plaque inside the arteries, and common health conditions such as obesity, diabetes, and metabolic disorders further increase that risk.
One important but often overlooked driver is elevated Lipoprotein(a), or Lp(a), a genetically determined lipid particle that is not routinely tested in general practice. High Lp(a) levels are associated with greater plaque build-up and arterial inflammation, significantly raising the risk of heart attacks and strokes. To date, no drug has been officially approved to directly lower Lp(a) levels, leaving a significant gap in care for people living with this inherited risk factor.
This trial is evaluating an investigational injectable treatment given every 12 weeks that may help reduce Lp(a) levels and lower the risk of serious heart events in people with established cardiovascular disease.
treatment design
Eligible participants will be randomly assigned to receive either the investigational treatment or a placebo, with a 50% chance of receiving either. The injection is administered under the skin, into the abdomen, thigh, or upper arm, every 12 weeks in the clinic over 60 weeks.
Participants will attend regular visits for health checks, heart imaging, and safety assessments. Even if a participant stops receiving the investigational treatment, they may still be asked to complete follow-up assessments.