Not yet recruitingPHASE3INTERVENTIONAL

A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk

This research study is looking into a new medication called lepodisiran. The main goal is to find out if this medicine can help reduce the build-up of fatty deposits, known as plaque, in the arteries that supply blood to the heart. This study is for adults aged between 45 and 80 who have high levels of a specific type of cholesterol called Lipoprotein(a), or Lp(a), and who have either already experienced heart-related issues or are considered to be at a high risk of developing them. The study will compare lepodisiran to a dummy medicine (placebo) and will use special imaging techniques to observe any changes in these plaques. Taking part would last approximately 120 weeks.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

252

Start

01 May 2026

Estimated completion

01 Apr 2029

Atherosclerosis Cardiovascular Diseases Lipoprotein(a)

What is this study about?

This research study aims to understand if a new medication called lepodisiran can help people with high levels of Lipoprotein(a), often shortened to Lp(a). Lp(a) is a specific kind of cholesterol in your blood that, when elevated, can increase your chances of developing heart disease. Currently, there aren't many widely available treatments specifically designed to lower Lp(a), so this study is an important step in exploring new options.

The main focus of the study is to see how lepodisiran affects the fatty deposits, also known as plaque, that can build up inside your heart's arteries. These plaques can narrow the arteries and lead to serious heart problems. Researchers will compare lepodisiran against a 'placebo' – a dummy medicine that looks the same but contains no active drug. This allows them to clearly see if any changes are due to lepodisiran itself. They'll use a special type of X-ray scan called a Coronary Computed Tomography Angiography (CCTA) to get detailed pictures of your heart's blood vessels and carefully measure this plaque.

By participating, you would be helping medical science learn more about Lp(a) and how to better manage heart disease risk for people with high levels. The information gathered from this study could potentially lead to new treatments that improve the health and well-being of many people in the future.

Key takeaways

The study tests a new medicine, lepodisiran, for high Lp(a) and heart artery plaque.
It's for adults 45-80 with high Lp(a) who have heart disease or are at high risk.
Lp(a) is a type of cholesterol that can increase your heart disease risk.
Researchers will use special scans (CCTA) to observe changes in plaque.
Participation lasts about 2.5 years and involves regular clinic visits and tests.
You might receive the new medicine or a dummy medicine (placebo).

Who may be eligible?

To join this study, you would need to be aged between 45 and 80 years old. A key requirement is having a confirmed high level of a specific type of cholesterol called Lp(a) in your blood. You also need to have either already experienced heart-related problems, such as a heart attack, or be considered at a high risk of having one for the first time. We'd also need to see evidence of narrowing in your heart's arteries through a special scan, even if you don't have symptoms. If you're currently taking medicines to lower your cholesterol, like statins, these would need to have been at a steady dose for at least eight weeks before you join the study.

There are certain reasons why you might not be able to participate. For example, if you've had a recent major heart health event within the last two months, or if you have uncontrolled high blood pressure. Severe kidney or heart failure would also exclude you. If you've had certain heart surgeries in the past, or are planning any heart procedures during the study period, you wouldn't be able to take part. Also, if you can't safely have the special CCTA scan, perhaps due to allergies to the dye used or other medical reasons, you wouldn't be eligible. The team will carefully check all these details with you.

Quick self-check

Are you between 45 and 80 years old?
Do you have high levels of Lp(a) cholesterol?
Have you experienced heart problems, or are you at high risk for them?
Are you able to have a special heart scan called a CCTA?
Do you have stable doses for any cholesterol-lowering medicines you take?
Have you avoided major heart-related events in the last 2 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, your involvement would last for approximately 120 weeks, which is about two and a half years. During this time, you would receive either the new study medicine, lepodisiran, or a placebo (a dummy medicine). You wouldn't know which one you're receiving, nor would the study team, to ensure the results are as unbiased as possible. You would have regular visits to the clinic for various assessments, which will include blood tests to check your Lp(a) levels and overall health, and regular physical examinations. A key part of the study involves having special heart scans (CCTA) at specific times to monitor the fatty deposits in your arteries. You'd also be asked about your health and any side effects you might experience. All these assessments are designed to carefully track your progress and see how the study medicine is working.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as contributing to medical knowledge that could help others in the future, and receiving close medical monitoring throughout the study. However, like all medicines, lepodisiran may have potential side effects, and some people might experience discomfort from the medical procedures like blood tests or scans. It's also possible that the medicine may not work for you, or you might receive the placebo. Your safety and well-being are paramount, and you would be fully informed about all known risks before joining. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (58)

UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, United States
Valley Clinical Trials, Inc.
Northridge, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, United States
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, United States
Jacksonville Center for Clinical Research
Jacksonville, United States
Merritt Island Medical Research, LLC
Merritt Island, United States
Inpatient Research Clinic
Miami Lakes, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, United States
CARE Institute - High Desert
Meridian, United States
Massachusetts General Hospital
Boston, United States
Profound Research LLC
Farmington Hills, United States
Vector Clinical Trials
Las Vegas, United States

+46 more sites — see the official record for the full list.

Common questions

What is Lp(a) and why is it important?

Lp(a) is a type of fat and protein particle in your blood. High levels can increase your risk of heart disease by contributing to fatty build-up in your arteries.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine fairly.

What is a CCTA scan?

A CCTA scan is a special type of X-ray that takes detailed pictures of the arteries around your heart to look for fatty deposits (plaque).

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctors will know whether you are receiving lepodisiran or the placebo during the study. This helps ensure unbiased results.

How long does the study last?

If you take part, your involvement in the study will last for approximately 120 weeks, which is about two and a half years.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.