High Lp(a) & Heart Disease Study

Many people living with elevated lipoprotein(a) (also called Lp(a)) carry a significantly higher risk of heart attack and stroke. Unlike regular LDL cholesterol, Lp(a) is largely determined by genetics and is not effectively lowered by standard cholesterol medications such as statins. If you have been told you have a high Lp(a) level, this study may be of particular relevance to you.

This study is investigating two new investigational oral medications that work to lower Lp(a) and LDL cholesterol levels in people at elevated cardiovascular risk who are already on statin therapy. The medications are taken as tablets once daily - there are no injections involved.

This is a double-blind, placebo-controlled study, meaning some participants will receive placebo tablets. Neither you nor the clinical team will know which treatment you have been assigned. All participants will continue their existing prescribed medications throughout the study.

As a participant, you will receive study medication at no cost, regular health monitoring by our experienced clinical team, and reimbursement for your time and travel. All study-related tests and consultations are provided free of charge.

 You may be eligible to join this study if you meet the criteria below. Our team will confirm your eligibility at a screening visit — you do not need to be certain of every item before registering interest

• You are aged 18 to 75 years
• You have been told you have a high Lp(a) level (≥ 150 nmol/L on a fasting blood test)
• You have a history of heart attack, stroke, coronary artery disease, or peripheral artery disease — or you are at elevated risk of a first cardiovascular event (e.g. due to diabetes, kidney disease, significant atherosclerosis, or current smoking)
• You have an elevated LDL cholesterol level (≥ 1.4 mmol/L if you have existing heart disease, or ≥ 1.8 mmol/L if at high risk)
• You are currently taking a moderate or high-intensity statin, on a stable dose for at least 28 days
• You are not currently taking fibrate therapy or certain injectable or oral cholesterol-lowering medications — our team will discuss this with you
• You do not have severe kidney disease or a recent acute cardiovascular event within the last 6 months
• You are willing to attend clinic visits in Ipswich or East Brisbane over approximately 15 weeks

Other eligibility criteria apply. Our team will walk through all inclusion and exclusion criteria with you at your screening visit — please register your interest and we will be in touch.

• You will be randomly assigned to receive either an investigational study medication (at one of several doses) or a placebo — neither you nor the clinical team will know which you have received
• A screening visit up to 3 weeks before treatment begins, to confirm eligibility — including fasting blood tests, an ECG, blood pressure measurement, and medical history review
• Six clinic visits during the 12-week treatment period: at the start (Day 1), and again at approximately weeks 1, 2, 4, 8, and 12. Each visit has a 3-day flexibility window
• One follow-up visit approximately 3 weeks after your last dose, to assess your health after completing treatment
• Fasting blood samples at most visits — please fast for at least 8 hours overnight before each clinic appointment (water is permitted up to 1 hour before blood collection)
• An ECG, blood pressure and pulse check, and weight measurement at each visit
• Study tablets taken once daily at home; your first dose on clinic days will be taken under the supervision of our team
• All study medications, tests, and consultations are provided at no cost to you
• You are free to withdraw at any time, for any reason, without affecting your usual medical care

Early access to a new treatment

This study investigates medications targeting Lp(a) — a risk factor that current medications cannot effectively treat. Participants may benefit from meaningful reductions in both Lp(a) and LDL cholesterol before these treatments are publicly available.

Close monitoring of your heart health

Regular ECGs, blood pressure checks, and detailed blood tests throughout the study provide a level of cardiovascular monitoring well beyond standard GP care.

No cost to you

All study visits, medications, tests, and consultations are provided free of charge. Participants also receive reimbursement for reasonable travel expenses.

Help others living with high Lp(a)

Elevated Lp(a) affects approximately 1 in 5 Australians and is a leading but under-recognised cause of heart attack and stroke. Your participation directly advances new treatments for your community.

Footer note: Your privacy is important. All personal information will be kept strictly confidential.

This study is opening soon at our Ipswich and East Brisbane sites. To register your interest:

• Visit www.lcr.health and complete the online expression of interest form
• Call our team directly on (07) 3180 8045
• Email us at paul@lcr.health

Once you register, a member of our clinical team will contact you to discuss the study in more detail, answer any questions, and confirm whether you may be eligible for a screening visit.