Not recruiting

Study of LY3819469 for Adults with High Lipoprotein(a) Levels

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition known as elevated lipoprotein(a), which is a type of lipoprotein disorder. Lipoproteins are particles in the blood that carry cholesterol and other fats. When levels of lipoprotein(a) are high, it can increase the risk of heart disease. The study is testing a new treatment called LY3819469, which is a solution for injection developed by Eli Lilly and Company. This treatment is being compared to a placebo to see if it can effectively reduce the levels of lipoprotein(a) in the blood.

The purpose of the study is to determine if LY3819469 is better than a placebo in lowering lipoprotein(a) levels. Participants in the study will receive either the treatment or a placebo through an injection under the skin, known as a subcutaneous injection. The study will last for a period of time, during which participants will be monitored to see how their lipoprotein(a) levels change. The maximum daily dose of the treatment is 400 milligrams, and the total dose over the course of the study can be up to 800 milligrams.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on the safety and effectiveness of LY3819469 for people with elevated lipoprotein(a) levels, potentially leading to new treatment options for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the investigational medication LY3819469 or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.
Step 2
Medication administration
The medication or placebo will be given as a solution for injection under the skin, known as a subcutaneous injection. The exact dosage and frequency will be determined by the study team and communicated to you.
Step 3
Treatment period
The treatment period will last for several months. During this time, you will continue to receive the injections as scheduled. The main goal is to evaluate the effect of the medication on reducing lipoprotein(a) levels in your blood.
Step 4
Monitoring and assessments
Throughout the study, regular monitoring and assessments will be conducted. This includes blood tests to measure lipoprotein(a) levels and other health checks to ensure your safety and well-being.
Step 5
End of study
The study is expected to conclude by January 16, 2024. At the end of the study, a final assessment will be conducted to evaluate the overall effects of the treatment.

Who can join the trial?

5 criteria

Participants must be at least 40 years old.
Participants must have a level of Lp(a) (a type of fat in the blood) of at least 175 nmol/L at screening.
If participants are taking lipid-lowering drugs (medications to reduce fats in the blood) or hormone therapy, they need to be on a stable dose for at least 4 weeks before screening.
Participants must have a body mass index (BMI) between 18.5 and 40. BMI is a measure of body fat based on height and weight.
Males must agree to use highly effective contraception methods, or participants must be women who are not of childbearing age.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to the study medication.
Patients who are unable to follow the study procedures or instructions.
Patients with a history of drug or alcohol abuse within the past year.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of heart attack or stroke within the last 6 months.
Patients who are currently taking medications that might interfere with the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amphia Hospital
Breda, The Netherlands
Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Verified
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Brasov, Romania

Trial locations

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Investigated drugs

LY3819469 is a medication being studied to see if it can help lower levels of a specific type of fat in the blood called lipoprotein(a), or Lp(a). High levels of Lp(a) can increase the risk of heart disease. This medication is being tested to find out if it can reduce Lp(a) levels more effectively than a placebo, which is a substance with no active ingredients used for comparison in clinical trials. The goal is to determine if LY3819469 can be a safe and effective treatment for people with elevated Lp(a) levels.

Ly3819469 Sodium

What is already known about the treatment

LY3819469 – LY3819469 is administered orally in the form of a pill. It is currently being studied in clinical trials to determine its effectiveness and safety for treating lipoprotein disorders, specifically in reducing elevated levels of lipoprotein(a) in adults. The medication works by targeting and reducing the production of lipoprotein(a) in the body, which is a type of fat that can contribute to heart disease. LY3819469 is classified as a lipid-lowering agent, which means it helps to lower certain types of fats in the blood.

Investigated diseases

Lipoprotein Disorder – Lipoprotein disorder involves abnormalities in the levels or types of lipoproteins in the blood. Lipoproteins are particles that transport cholesterol and triglycerides through the bloodstream. This disorder can lead to an imbalance, causing either high or low levels of lipoproteins. Over time, these imbalances can contribute to the buildup of fatty deposits in blood vessels. This can affect blood flow and potentially lead to complications in the cardiovascular system. The progression of the disorder depends on the specific type and severity of the lipoprotein imbalance.