This study focuses on patients with hyperlipidemia (high levels of blood fats) and atherosclerotic cardiovascular disease, a condition where arteries become hardened and narrowed. The study will test a new medication called AZD0780 (laroprovstat) in people who have high levels of “bad” cholesterol (also known as LDL cholesterol) despite taking their usual cholesterol-lowering medicines.
The purpose of this research is to determine how well AZD0780 works compared to placebo in lowering LDL cholesterol levels after 12 weeks of treatment. The medication comes as a film-coated tablet that is taken by mouth. Some participants will receive AZD0780, while others will receive a placebo.
The study will last for 52 weeks (one year), during which participants will continue taking their regular cholesterol-lowering medications. Throughout the study, researchers will measure various types of cholesterol and other blood fats, including apolipoprotein B, non-HDL cholesterol, and lipoprotein(a), to understand how well the treatment works.
1Initial assessment and medication start
Your blood cholesterol levels will be measured after fasting
You will receive AZD0780 tablets or placebo (inactive substance) tablets for oral use
You will continue your current cholesterol-lowering medications, including statins if you are taking them
212-week assessment
Your blood cholesterol levels will be measured again after 12 weeks of treatment
The main focus will be on measuring your LDL-C (bad cholesterol) levels
Additional blood tests will check other types of fats in your blood, including: Apo B, non-HDL-C, total cholesterol, and Lp(a)
328-week assessment
Your blood cholesterol levels will be checked again at 28 weeks
The focus remains on measuring changes in your LDL-C levels
452-week assessment
A final measurement of your blood cholesterol levels will be taken at 52 weeks
This completes one year of participation in the study
The main focus will be on measuring the long-term changes in your LDL-C levels
Who Can Join the Study?
Must be at least 18 years old when signing the consent form
Must have either:
A history of heart and blood vessel disease (like heart attack, chest pain, stroke, or artery problems), or
Be at risk for heart disease due to conditions like:
Narrowed arteries in multiple areas
Diabetes
High blood pressure
Smoking
Kidney disease
Obesity
Must have specific levels of cholesterol (LDL-C) in blood tests:
At least 55 mg/dL if you have existing heart disease
At least 70 mg/dL if you are at risk but don’t have heart disease yet
Must be taking the highest tolerated dose of cholesterol-lowering medications (statins) with:
A stable dose for more than 28 days
If unable to take high-dose statins, must be on lower doses
If not taking any statins, must have documented side effects from trying at least 2 different statins
Both men and women can participate
Who Cannot Join the Study?
History of serious allergic reactions or severe sensitivity to any medications
Currently pregnant or breastfeeding women
Severe liver problems (as indicated by liver function tests more than 3 times the normal upper limit)
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Germany
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Germany
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Czechia
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Czechia
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Bulgaria
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Bremen
Germany
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Rzeszow
Poland
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Bulgaria
Not recruiting
30.05.2025
Czechia
Not recruiting
30.05.2025
Germany
Not recruiting
30.05.2025
Hungary
Not recruiting
30.05.2025
Poland
Not recruiting
30.05.2025
Slovakia
Not recruiting
30.05.2025
Spain
Not recruiting
30.05.2025
Trial locations
AZD0780 is an investigational medication being studied for its effects on lowering LDL cholesterol (often called “bad” cholesterol) in patients who have high cholesterol levels. This medication is being tested in people who either have existing cardiovascular disease or are at risk of developing cardiovascular problems. The medication is designed to help reduce cholesterol levels in the blood, which may help prevent heart disease and related complications.
Hyperlipidemia – A condition characterized by elevated levels of lipids (fats) in the blood, particularly cholesterol and triglycerides. The condition develops gradually over time and can be influenced by both genetic factors and lifestyle choices. It often occurs without noticeable symptoms but leads to fatty deposits in blood vessels. The condition affects how the body processes and stores fats from food.
Atherosclerotic cardiovascular disease – A condition where plaque builds up inside the arteries, causing them to narrow and harden over time. The plaque consists of fat, cholesterol, calcium, and other substances found in the blood. As arteries become narrower, blood flow to various parts of the body becomes restricted. The process develops gradually over many years and can affect arteries throughout the body.
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Bulgaria 
Czechia 
Germany 
Hungary 
Poland 
Slovakia 
Spain