Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

This research study, called ACCLAIM-Lp(a), is testing a new medication called lepodisiran. The main goal is to see if lepodisiran can lower the risk of serious heart problems, like heart attacks and strokes, in adults who have high levels of a type of fat in their blood called lipoprotein(a) (Lp(a)). Participants selected for this study either already have heart disease or are at a high risk of developing it. The study drug will be given as an injection just under the skin. We're also looking to enrol more people to understand how different ways of giving the drug might affect Lp(a) levels. This is a Phase 3 trial, meaning it's one of the final steps before a drug might be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

17,300

Start

05 Mar 2024

Estimated completion

01 Mar 2029

Atherosclerotic Cardiovascular Disease (ASCVD)Elevated Lp(a)

What is this study about?

This important research study, called ACCLAIM-Lp(a), is investigating a new medication called lepodisiran. The main purpose is to find out if this medicine can help lower the risk of serious heart and blood vessel problems, such as heart attacks and strokes, in people who have particularly high levels of a substance in their blood called lipoprotein(a), often shortened to Lp(a).

Lp(a) is a type of fat and protein found in your blood, and high levels of it have been linked to an increased risk of heart disease. While there are treatments for other types of cholesterol, there aren't many specific treatments for high Lp(a) yet. That's why this study is so important — it's exploring a new way to potentially protect people from future heart and stroke events.

The study will involve adults who either already have heart or blood vessel disease (like after a heart attack or needing a procedure to open blocked arteries) or who are considered at high risk of having a heart attack or stroke. Participants will be given the study medication, lepodisiran, as an injection under the skin. Another part of the study will involve additional participants to explore if giving the medicine in different ways can also effectively lower Lp(a) levels.

Key takeaways

This study tests a new drug, lepodisiran, for high lipoprotein(a).
It aims to lower the risk of heart attacks and strokes.
It's for adults with existing heart disease or those at high risk.
The drug is given as an injection under the skin.
Participation involves regular clinic visits and health monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to meet certain requirements. Firstly, you must be 18 years or older and have a high level of lipoprotein(a) (Lp(a)) in your blood, specifically 175 nanomoles per litre or higher.

Secondly, you must either have existing heart or blood vessel disease (like heart disease or blockages in arteries) that has caused an event (like a heart attack) or required a procedure. Alternatively, if you are 55 years or older, you might be eligible if you are at high risk of a first heart attack or stroke. This could include having a known history of conditions like coronary artery disease, narrowing of major arteries, or blocked arteries in your legs, even if you haven't had an event yet. It could also apply if you have a family history of very high cholesterol (familial hypercholesteremia) or a combination of several other risk factors.

However, some conditions would mean you cannot take part. For example, if you've had a recent major heart event or surgery in the past two months, have very high blood pressure that isn't under control, severe heart failure, or have had a specific blood treatment called lipoprotein apheresis recently. Also, people with serious kidney or liver problems would not be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high lipoprotein(a) (Lp(a)) levels of 175 nmol/L or higher?
Have you had a heart attack, stroke, or a procedure for blocked arteries, OR are you 55 or older with other heart risk factors?
Have you NOT had a major heart event or surgery in the past 2 months?
Do you have well-controlled blood pressure?
Do you NOT have severe problems with your kidneys or liver?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regularly visiting a clinic for health checks and to receive the study medication. This medicine, lepodisiran, will be given as an injection just under your skin. You will either receive the active drug or a placebo (a dummy drug with no active ingredients). This is decided randomly, like flipping a coin, and neither you nor your study doctor will know which you are receiving. The study team will monitor your health closely, including taking blood samples to check your Lp(a) levels and overall health. They will also keep track of any changes in your health or any new symptoms you experience. The total duration of your participation in the study, including all follow-up, will be discussed in detail by the study team.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might benefit from closer medical attention and possibly receive a new treatment that could improve your health, though this is not guaranteed as you might receive a placebo. There could be risks and side effects from the study medication, similar to any medicine, and these will be fully explained to you. Although every effort is made to minimise risks, some unknown side effects could occur. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (933)

Birmingham Clinical Research
Verified postcode
Birmingham, United States
Alliance for Multispecialty Research, LLC
Verified postcode
Daphne, United States
SEC Clinical Research
Verified postcode
Dothan, United States
Alliance for Multispecialty Research, LLC
Verified postcode
Mobile, United States
Mobile Heart Specialists
Verified postcode
Mobile, United States
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Verified postcode
Gilbert, United States
Mercy Gilbert Medical Center
Verified postcode
Gilbert, United States
Sun City Clinical Research
Verified postcode
Glendale, United States
Elite Clinical Studies, LLC
Verified postcode
Phoenix, United States
Helios Clinical Research - Phoenix
Verified postcode
Phoenix, United States
Absolute Clinical Research
Verified postcode
Phoenix, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Verified postcode
Sun City West, United States

Common questions

What is lipoprotein(a)?

Lipoprotein(a), or Lp(a), is a type of fat and protein particle in your blood. High levels of Lp(a) are linked to a higher risk of heart disease and stroke.

Why is this study important?

This study is important because there are currently limited treatments specifically for high Lp(a). It aims to find a new way to reduce heart disease and stroke risk.

What is a Phase 3 study?

A Phase 3 study is one of the final stages of clinical research. It involves a larger number of people to confirm the safety and effectiveness of a new drug before it can be considered for general use.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study drug but has no active ingredients. It helps researchers compare the effects of the active drug to no treatment.

Will I know if I'm getting the actual drug or the placebo?

No, during the main part of the study, neither you nor your study doctor will know whether you are receiving the active drug or the placebo. This helps ensure unbiased results.