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Study of LY3473329 for Adults with High Lipoprotein(a) Levels at Risk for Heart Problems

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. People with this condition have higher levels of a specific type of fat in their blood, which can increase the risk of heart-related problems. The study is testing a new treatment called LY3473329, which is a film-coated tablet taken by mouth. This medication is being developed by Eli Lilly and Company Limited and is a synthetic small molecule designed to help manage the levels of lipoprotein(a) in the blood.

The purpose of the study is to evaluate how effective and safe LY3473329 is for adults who have high levels of lipoprotein(a) and are at high risk for cardiovascular events, such as heart attacks or strokes. Participants in the study will be randomly assigned to receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of 12 weeks, during which participants will take the medication or placebo once daily.

Throughout the study, participants will be monitored to see how their lipoprotein(a) levels change from the beginning to the end of the 12-week period. The study aims to provide valuable information on whether LY3473329 can effectively lower lipoprotein(a) levels and reduce the risk of cardiovascular events in people with this condition. This research could lead to new treatment options for managing elevated lipoprotein(a) and improving heart health.

The research process

The trial runs in 4 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 informed about the purpose and procedures involved. The study aims to evaluate the effectiveness and safety of the medication LY3473329 for individuals with high levels of lipoprotein(a), which is a type of fat in the blood, and who are at high risk for heart-related events.
Step 2
Medication administration
You will be randomly assigned to receive either the medication LY3473329 or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The medication is taken orally, meaning you will swallow a film-coated tablet once daily.
The duration of taking the medication is planned from the start of the study until the end of the treatment period, which is approximately 12 weeks.
Step 3
Regular check-ups
Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include assessments of your lipoprotein(a) levels and other health indicators.
The primary goal is to observe the percent change in your lipoprotein(a) levels from the beginning of the study to week 12.
Step 4
End of study
At the end of the study, you will have a final assessment to evaluate the overall effects of the medication on your health.
The study is expected to conclude by August 2024, and you will be informed about the results and any further steps if necessary.

Who can join the trial?

6 criteria

Participants must be at least 40 years old.
Participants must have a level of Lp(a) (a type of fat in the blood) that is 175 nmol/L or higher at screening.
Participants must have one of the following conditions: coronary artery disease (heart disease), stroke (a brain attack), peripheral artery disease (narrowed blood vessels outside of the heart), familial hypercholesterinemia (a genetic condition causing high cholesterol), or type 2 diabetes (a condition affecting blood sugar).
If participants are taking certain medications, such as drugs to lower cholesterol, testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone, they must be on a stable dose before and during the study.
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.
Both males and females can participate. Females who can have children must agree to use highly effective birth control methods, or they must be women who cannot have children anymore.

Who cannot join the trial?

10 criteria

Participants with any other serious health condition that might interfere with the study.
Participants who are pregnant or breastfeeding.
Participants who have had a recent major surgery.
Participants who are currently participating in another clinical trial.
Participants with a history of drug or alcohol abuse.
Participants who have an allergy to the study medication.
Participants with uncontrolled high blood pressure.
Participants with severe liver or kidney disease.
Participants with a history of heart attack or stroke within the last 6 months.
Participants who are unable to comply with the study procedures.

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Verified sites

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

Verified
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemet, Hungary
Verified
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Budapest, Hungary
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Kath. St. Paulus GmbH
Dortmund, Germany

Trial locations

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Investigated drugs

LY3473329 is a medication being studied for its potential to help people who have high levels of a specific type of fat in their blood called lipoprotein(a), or Lp(a). High levels of Lp(a) can increase the risk of heart problems. This medication is taken by mouth once a day and is being tested to see if it can safely lower Lp(a) levels and reduce the risk of heart-related events in adults who are at high risk.

Ly3473329

What is already known about the treatment

LY3473329 – LY3473329 is an oral medication taken once daily, currently being studied in clinical trials to assess its effectiveness and safety for adults with high levels of lipoprotein(a), which is a type of fat in the blood that can increase the risk of heart problems. This medication is still under investigation, and its full effects and approval status are being evaluated in medical research. It is primarily intended for people with lipoprotein disorders who are at high risk for cardiovascular events. LY3473329 works by targeting specific pathways in the body to help reduce the levels of lipoprotein(a), potentially lowering the risk of heart-related issues. It falls under the category of drugs aimed at managing lipid levels in the blood.

Investigated diseases

Lipoprotein Disorder – Lipoprotein disorder involves abnormal levels of lipoproteins in the blood, which are molecules made of fat and protein that transport cholesterol and triglycerides. This condition can lead to an imbalance in the types of cholesterol, such as low-density lipoprotein (LDL) and high-density lipoprotein (HDL). Over time, elevated levels of certain lipoproteins, like lipoprotein(a) or Lp(a), can contribute to the buildup of fatty deposits in the arteries. This buildup can cause the arteries to narrow and harden, a process known as atherosclerosis. As the condition progresses, it may increase the risk of cardiovascular events, such as heart attacks or strokes. The progression of lipoprotein disorder is influenced by genetic factors, lifestyle, and other health conditions.