In short
Currently, there are 2 ongoing clinical trials testing new treatments for lipoprotein metabolism disorder, specifically focusing on elevated lipoprotein(a) levels. These studies are being conducted across several European countries and are investigating oral and injectable medications aimed at reducing lipoprotein(a) levels to lower the risk of heart-related problems.
Clinical trial locations
- Denmark
- Germany
- Hungary
- Netherlands
- Romania
- Spain
Study of LY3473329 for Adults with High Lipoprotein(a) Levels at Risk for Heart Problems
This clinical trial is testing a new oral medication called LY3473329 for adults who have high levels of lipoprotein(a) in their blood. Lipoprotein(a) is a specific type of fat that, when elevated, can increase the risk of heart attacks, strokes, and other cardiovascular problems. The medication is taken as a film-coated tablet once daily for approximately 12 weeks.
Main inclusion criteria:
- Must be at least 40 years old
- Must have lipoprotein(a) levels of 175 nmol/L or higher at screening
- Must have one of the following conditions: coronary artery disease, previous stroke, peripheral artery disease, familial hypercholesterinemia, or type 2 diabetes
- If taking cholesterol-lowering medications or hormone treatments, must be on a stable dose
- Must have a body mass index between 18.5 and 40
- Women who can have children must use highly effective birth control methods
Main exclusion criteria:
- Any other serious health condition that might interfere with the study
- Pregnant or breastfeeding
- Recent major surgery
- Currently participating in another clinical trial
- History of drug or alcohol abuse
- Allergy to the study medication
- Uncontrolled high blood pressure
- Severe liver or kidney disease
- Heart attack or stroke within the last 6 months
- Unable to comply with study procedures
Focus and goals: The study aims to evaluate whether LY3473329 can effectively lower lipoprotein(a) levels over the 12-week treatment period and assess the safety of the medication. Participants will be randomly assigned to receive either the active medication or a placebo. Throughout the study, regular check-ups will monitor changes in lipoprotein(a) levels and other health indicators.
Investigational drug: LY3473329 is a synthetic small molecule taken orally once daily. It is designed to target specific pathways in the body to help reduce lipoprotein(a) levels, potentially lowering the risk of heart-related events in people with this condition.
Study of LY3819469 for Adults with High Lipoprotein(a) Levels
This trial is investigating LY3819469, an injectable medication for adults with elevated lipoprotein(a) levels. Unlike the first trial, this medication is given as a subcutaneous injection under the skin rather than as an oral tablet. The study compares the investigational drug to a placebo to determine if it can effectively reduce lipoprotein(a) levels in the blood.
Main inclusion criteria:
- Must be at least 40 years old
- Must have lipoprotein(a) levels of at least 175 nmol/L at screening
- If taking lipid-lowering drugs or hormone therapy, must be on a stable dose for at least 4 weeks before screening
- Must have a body mass index between 18.5 and 40
- Males must agree to use highly effective contraception methods, or participants must be women who are not of childbearing age
Main exclusion criteria:
- Any other serious health condition that might interfere with the study
- Pregnant or breastfeeding
- Participated in another clinical trial within the last 30 days
- History of allergic reactions to the study medication
- Unable to follow study procedures or instructions
- History of drug or alcohol abuse within the past year
- Uncontrolled high blood pressure
- Severe liver or kidney disease
- Heart attack or stroke within the last 6 months
- Currently taking medications that might interfere with the study
Focus and goals: The primary objective is to determine if LY3819469 is more effective than a placebo in lowering lipoprotein(a) levels. Participants will be randomly assigned to receive either the treatment or placebo injections over several months. Regular monitoring will include blood tests to measure lipoprotein(a) levels and other health assessments to ensure participant safety.
Investigational drug: LY3819469 is administered through subcutaneous injections, with a maximum daily dose of 400 milligrams. The medication works by targeting and reducing the production of lipoprotein(a) in the body, which is classified as a lipid-lowering agent designed to reduce specific types of fats in the blood.
Summary
Both ongoing clinical trials for lipoprotein metabolism disorder focus specifically on reducing elevated lipoprotein(a) levels in adults who are at increased risk for cardiovascular events. The trials are being conducted across multiple European countries, with Germany and the Netherlands participating in both studies, demonstrating a concentration of research activity in these regions.
A notable difference between the two trials is the method of drug administration: one study tests an oral medication taken once daily, while the other investigates an injectable treatment given under the skin. Both medications, LY3473329 and LY3819469, are developed by Eli Lilly and Company and share similar inclusion criteria, requiring participants to be at least 40 years old with lipoprotein(a) levels of 175 nmol/L or higher.
The trials employ similar exclusion criteria to ensure participant safety, excluding individuals with recent cardiovascular events, severe organ disease, or those unable to comply with study procedures. Both studies use placebo-controlled designs to properly evaluate the effectiveness of the investigational medications in reducing lipoprotein(a) levels and potentially lowering cardiovascular risk.
