phase II
enrolling

The Heart Disease and Cholesterol Trial

For adults aged 45–80 with elevated Lp(a) and existing cardiovascular disease, or aged 55–80 at risk of a first heart event. Conducted at our South Bank clinic in Brisbane and Birtinya, in Sunshine Coast.
Age 45-80
day visits
Up to $1948
About this trial

Evaluating an investigational therapy for elevated LDL-C and lipid management

Cardiovascular disease (CVD) remains one of Australia's most significant health challenges. More than 4.5 million Australians, 1 in 6 people, are living with CVD, and it accounts for around 1 in 4 deaths nationally, with someone dying from it approximately every 12 minutes. More than 590,000 Australians are living with coronary heart disease, the most common form.

One underrecognised driver of cardiovascular risk is elevated Lipoprotein(a), or Lp(a), an inherited type of "bad" cholesterol that increases the risk of plaque building up in the arteries. Around 1 in 5 people have elevated Lp(a) levels, which can increase the risk of heart attack or stroke by 2-4 times. Yet most are unaware because it is not detected on standard cholesterol tests. Unlike other cholesterol types, Lp(a) cannot be meaningfully reduced through diet, exercise, or existing cholesterol medications. Currently, no approved medicine specifically targets Lp(a).

This heart and cholesterol trial is investigating whether an investigational medicine given every 26 weeks can reduce the build-up of fatty plaque in the heart's arteries. The clinic team will measure Lp (a) levels using CT imaging in people with elevated Lp(a), helping researchers understand whether this approach can meaningfully reduce long-term cardiovascular risk.
The investigational medicine is given as a single injection every 26 weeks using a prefilled autoinjector pen, similar to devices used for some diabetes or arthritis medicines, making dosing straightforward and infrequent.
Eligibility

Do you qualify for a heart disease and cholesterol trial?

You may be eligible to apply for this specialised cardiovascular and cholesterol trial if you meet the following pathways:

Pathway 1 — Aged 45–80 with existing cardiovascular disease:

  • Elevated Lp(a) levels of at least 175 nmol/L
  • Established ASCVD, such as a previous heart attack, stroke, or artery revascularisation, that occurred at least 60 days ago

Pathway 2 — Aged 55–80 at risk of a first cardiovascular event:

  • Elevated Lp(a) levels of at least 175 nmol/L
  • No previous cardiovascular event but documented artery narrowing or multiple cardiovascular risk factors

Both pathways require:

  • Able and willing to attend study visits, follow study procedures, and provide informed consent
  • No major heart event, stroke or major surgery within the past 60 days
  • No expectation of needing major heart or blood vessel surgery in the near future
What's involved

Commitment and procedures

Visit type
day visits
total visits
9
duration
104 weeks
treatment
Autoinjector pen

procedures

Physical examination
Vital signs and blood monitoring
Coronary CT Angiography imaging
Blood sample collection
ECG (electrocardiogram)
Urine sample collection
Questionnaires
Treatment or placebo injection

treatment design

Eligible participants will be randomly assigned to receive either the investigational medicine or a placebo injection. Participants will not know which they are receiving. The medicine is administered once every 26 weeks using a single-use prefilled autoinjector pen, making dosing infrequent and straightforward.

Participants will attend up to 9 study visits at our South Bank or Birtinya clinics over approximately 104 weeks. The purpose of this trial is to assess whether the investigational medicine can reduce the build-up of fatty plaque in the heart's arteries, measured by CT imaging. Throughout your time in this cholesterol trial, you will receive comprehensive medical assessments from our experienced team, and all procedures will be explained clearly.
More information

Have questions? We're here to help.

Contact our recruitment team directly. They're happy to answer any questions before you apply to the heart and cholesterol trial. Please do not send personal medical information by email.
Phone
+07 5409 8640
Hours
Mon–Fri, 8am–5pm
Trial at a glance
Status
enrolling
Phase
phase II
Therapeutic Area
Ages
45-80
Duration
104 weeks
Visits
9 visits
Location
Brisbane and Birtinya clinics
PROTOCOL
J3L-MC-EZEJ ASCVD
Reimbursement
Up to $1948

Ready to check your eligibility?

Takes ~2 minutes to apply for this cholesterol trial. Our team will call you within 1–2 business days.
Apply for this trial →
We won't share your details with third parties.
This trial has been reviewed by an independent human research ethics committee.

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