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Effect of Lepodisiran on Coronary Plaque in Adults with Elevated Lipoprotein(a) and Established Atherosclerotic Cardiovascular Disease or High Risk for First Event

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have high levels of Lipoprotein(a) and who have already experienced heart problems or are at high risk for a first heart event. These individuals typically have Cardiovascular Diseases caused by Atherosclerosis, a condition where fatty deposits, called plaque, build up inside the arteries that supply the heart. The medication being tested is called Lepodisiran, which is given as a liquid that is injected just under the skin. Some participants will receive a harmless substance that looks the same as the medication but does not contain the active drug, called a placebo.

The main goal of the trial is to see whether Lepodisiran can reduce the amount of plaque in the coronary arteries. Participants will receive a series of injections over several months and will have routine check‑ups that may include imaging scans to look at the arteries. Throughout the study, researchers will compare the changes in plaque size between those who receive Lepodisiran and those who receive the placebo, to determine if the drug can help lower the risk of future heart events.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and assignment
After you join the study, study staff will assign you to either lepodisiran or a matching placebo in a randomized, double-blind manner, meaning you will not know which product you receive.
Step 2
Baseline measurements
Before receiving any medication, you will have imaging of your heart arteries to measure coronary plaque and blood tests. this creates the starting point for later comparison.
Step 3
Medication administration
You will receive a subcutaneous injection of the assigned product (lepodisiran or placebo) according to the schedule defined by the study. the exact dose is determined by the protocol, and injections will be given at the study site or at home if instructed.
Step 4
Regular follow‑up visits
You will return to the study site at scheduled intervals for safety checks, blood tests, and to receive additional injections as required. the frequency of visits follows the study protocol.
Step 5
Repeat imaging
After a period of treatment, you will undergo another imaging test to assess the change in noncalcified plaque volume. the difference from the baseline measurement will be used to evaluate the effect of the medication.
Step 6
Final assessment and study end
At the end of the study, a final set of measurements will be taken, and you will be informed about the overall results. participation ends after the final assessment.

Who can join the trial?

6 criteria

Have a blood level of Lp(a) (a type of cholesterol particle) that is 175 nmol/L or higher.
Have already been diagnosed with cardiovascular disease (heart or blood‑vessel problems) or be considered at risk for a first heart event.
Show evidence of coronary artery disease (narrowing of the heart’s arteries) on a screening scan called CCTA (a special type of CT scan of the heart).
If you are taking medicines that lower cholesterol—such as statins, prescription‑strength niacin, or PCSK9 inhibitors—the dose must have been stable and unchanged for at least 8 weeks.
Be an adult (generally 18 years of age or older).
Both males and females are eligible to participate.

Who cannot join the trial?

7 criteria

Had a major cardiovascular (CV) event such as a heart attack or stroke within the last 60 days, or has uncontrolled high blood pressure (blood pressure that is not well managed) at the screening visit.
Has moderate to severe renal dysfunction (meaning the kidneys are not working well).
Has severe heart failure (the heart cannot pump blood effectively).
Has previously undergone coronary artery bypass graft surgery (CABG) – a surgery that creates new pathways for blood around blocked heart arteries.
Is planning to have any of the following heart procedures soon: coronary angiography (a test that looks at heart arteries), percutaneous coronary intervention (PCI) (a procedure to open blocked arteries), another bypass surgery, or a heart valve operation.
Has already received a treatment that removes lipoproteins (fat‑carrying proteins) from the blood or has taken medication that specifically targets Lipoprotein(a) (Lp(a)).
Cannot safely undergo a coronary CT angiography (CCTA) because of medication intolerance, an allergy to the contrast dye used in the scan, or because of body shape or technical factors that make the test unsafe.

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Verified sites

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Complejo Hospitalario Universitario Insular Materno Infantil
Verified
Las Palmas De Gran Canaria, Spain
Hospital Clinico San Carlos
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Madrid, Spain
Semmelweis University
Responsive
Budapest, Hungary

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Investigated drugs

Lepodisiran is an experimental medicine being tested to see if it can lower the amount of a protein called Lp(a) in the blood. High levels of Lp(a) are linked to a higher risk of heart disease. In this study, participants receive Lepodisiran as a liquid that is injected just under the skin. The goal is to find out whether the medicine can reduce the buildup of plaque in the coronary arteries of adults who already have heart disease or who are at risk for a first heart‑related event.

Ly3819469 Sodium

What is already known about the treatment

Placebo to match LY
This is an inactive solution that looks like the real drug but contains no active ingredients. It is given by injection in the same way as the test drug to keep the study fair. The placebo has no therapeutic use and is only used as a control in research. It helps researchers see if any changes are due to the actual medication.
Lepodisiran
Lepodisiran is a clear solution for injection that is given under the skin (subcutaneous use). It is an experimental small‑interfering RNA (siRNA) medicine that lowers the protein lipoprotein(a) by blocking the gene that makes it. Currently it is being studied in Phase 3 trials for people with high Lp(a) and a risk of heart disease, and it is not yet approved for general medical use. Its main purpose is to reduce plaque buildup in arteries and lower the chance of heart problems.

Investigated diseases

Cardiovascular Diseases
A group of conditions that affect the heart and blood vessels, including problems with blood flow and vessel walls. Over time, these conditions can lead to the buildup of material inside arteries, making them narrower and less flexible. As the vessels change, the heart may have to work harder to pump blood through the body. This can cause gradual changes in heart size and function. The condition often progresses silently until noticeable changes in circulation occur.
Atherosclerosis
A disease where fatty deposits build up on the inner walls of arteries, forming plaques. The plaques can grow larger, causing the arteries to become stiff and narrowed. As the narrowing worsens, blood flow to organs and tissues can be reduced. The disease typically advances over many years, with plaques gradually changing in size and composition. This process can affect any major artery in the body.
Lipoprotein(a)
A blood protein that carries cholesterol and is inherited in many people. Higher levels tend to increase over a lifetime, contributing to the formation of arterial plaques. As concentrations rise, the risk of plaque buildup in arteries may grow. The condition usually persists without obvious symptoms, but the elevated protein can influence the progression of arterial disease.