Ongoing Clinical Trials for Dyslipidaemia
Currently, there are 5 ongoing clinical trials investigating treatments for dyslipidaemia, a condition characterized by abnormal levels of fats such as cholesterol and triglycerides in the blood. These studies are taking place across several European countries and are testing various medications including statins, combination therapies, and experimental drugs aimed at reducing cholesterol levels and lowering cardiovascular risk.
Clinical trial locations
- Czechia
- Denmark
- Greece
- Hungary
- Slovakia
- Spain
- Sweden
Study Comparing Rosuvastatin and Fenofibrate with Pravastatin and Fenofibrate for Patients with Mixed Dyslipidemia at High Risk of Heart Disease
This trial, taking place in Greece, is investigating mixed dyslipidaemia in patients at high or very high risk of heart disease. The study compares two different combination therapies to see which is more effective at lowering cholesterol levels.
Inclusion criteria: To participate, you must be over 18 years old and have been taking Pravafenix for at least 3 months for mixed dyslipidaemia. You need to be at high or very high risk for coronary heart disease, determined by factors such as high cholesterol, high blood pressure, or diabetes. Your LDL cholesterol levels must be at least 55 mg/dL if you’re very high risk, or 70 mg/dL if you’re high risk. Women who can become pregnant must use highly effective birth control throughout the trial.
Exclusion criteria: You cannot participate if your dyslipidaemia is not controlled, if your LDL cholesterol is not at the target level, if you’re not considered high or very high risk for heart disease, or if you fall outside the specified age range. Vulnerable populations who may need special protection are also excluded.
Focus: The study runs for 12 weeks and is designed to compare the effectiveness of rosuvastatin combined with fenofibrate versus Pravafenix in lowering LDL cholesterol levels. It is a double-blind trial, meaning neither participants nor researchers know which treatment is being given. Blood tests will be conducted regularly to measure various cholesterol levels and monitor for side effects.
Investigational drugs: The trial tests rosuvastatin, a medication that reduces cholesterol production in the liver, combined with fenofibrate, which lowers triglycerides and increases good cholesterol. These are compared against Pravafenix, which combines pravastatin and fenofibrate.
Study of RBD5044 in Adults with Mixed Dyslipidemia to Evaluate its Safety and Effectiveness
Conducted in Sweden, this trial examines a new injectable medication called RBD5044 for treating mixed dyslipidaemia over a 48-week period.
Inclusion criteria: You must be between 18 and 80 years old with fasting triglyceride levels between 150 and 499 mg/dL. Your cholesterol levels must show either non-HDL cholesterol of 100 mg/dL or higher, or LDL cholesterol of 70 mg/dL or higher, after at least 4 weeks of stable diet and statin therapy. Your body mass index must be between 18 and 40. Women who can become pregnant must use highly effective birth control from 2 weeks before starting until 4 weeks after the last dose. Men must use condoms or practice abstinence during the study and for 4 weeks afterward, unless they have had a vasectomy.
Exclusion criteria: You cannot participate if you’re outside the age range, have a history of severe allergic reactions, are pregnant or breastfeeding, have participated in another trial within 30 days, have severe liver or kidney disease, uncontrolled diabetes, recent heart attack or stroke, active cancer, uncontrolled high blood pressure, recent substance abuse, or significant mental health conditions.
Focus: The study monitors various blood fat levels throughout the 48-week treatment period, with the main assessment occurring at week 16. Regular blood tests measure triglycerides, cholesterol, and other fat-related substances. Health monitoring includes physical examinations, vital signs, and heart monitoring.
Investigational drugs: RBD5044 is an experimental medication belonging to a class called small interfering RNA. It is given as an injection under the skin and is designed to reduce harmful fat levels in the blood.
Study of Rosuvastatin Effects on Coronary Artery Plaque Volume in Patients with Stable Chest Pain Using CT Imaging
This Hungarian trial uses advanced CT imaging to examine how statin therapy affects plaque buildup in heart arteries in patients with stable chest pain.
Inclusion criteria: You must be between 45-75 years old if female, or 40-75 years old if male. You need a medical indication for a coronary CT angiography and must not have taken statins before. You cannot have conditions preventing a CT scan. You must have at least one partially-calcified or non-calcified plaque in your heart arteries, with an FFRCT value greater than 0.75 below the narrowing. You must be able to understand and sign the informed consent form.
Exclusion criteria: You cannot participate if you’re outside the age range, have known allergy to statins, have had a previous heart attack or unstable heart conditions, are pregnant or breastfeeding, are in other trials, cannot undergo CT angiography, have severe kidney disease preventing contrast dye use, have severe allergic reactions to contrast agents, have uncontrolled high blood pressure, active liver disease, recent major surgery, irregular heart rhythm affecting imaging, or cannot provide informed consent.
Focus: The study examines changes in coronary artery plaque characteristics over 3 months of treatment, with follow-up continuing to 24 months. Participants undergo CT scans at baseline, 3 months, and 24 months to measure plaque volume and composition. Blood tests monitor cholesterol levels and potential side effects throughout the study.
Investigational drugs: The trial uses Xeter, containing rosuvastatin (a statin medication), at a maximum daily dose of 40 milligrams, compared against placebo. The medication is taken orally as a film-coated tablet.
Study on Managing High Cholesterol in Cardiovascular Disease Patients Using Inclisiran
This Hungarian study investigates a comprehensive cholesterol management program using Leqvio (inclisiran) in patients at high risk for heart disease.
Inclusion criteria: You must be 18 years or older and agree to take maximum-dose statin therapy (either Rosuvastatin at least 20 mg or Atorvastatin at least 40 mg). Your fasting LDL cholesterol must be 1.8 mmol/L or higher at screening. You must have proven atherosclerotic coronary disease, shown either by non-obstructive coronary plaques on CT scan in at least four regions, or having had an acute coronary syndrome in the past year with multi-vessel disease and procedures involving at least two coronary arteries. You must provide written informed consent.
Exclusion criteria: Patients with primary hypercholesterolemia or mixed dyslipidaemia related to atherosclerotic cardiovascular disease cannot participate.
Focus: The program combines lifestyle changes, diet, exercise, and medications to lower LDL cholesterol. Regular visits track progress through blood tests measuring cholesterol levels. The study also uses CT scans to monitor plaque in arteries and evaluates changes in lifestyle, diet, and health behaviors. Leqvio is administered as an injection under the skin at a dose of 284 mg.
Investigational drugs: Leqvio (inclisiran) is designed to lower LDL cholesterol levels. The trial also emphasizes comprehensive lipid management through the Semmelweis Lipid Center Program, which combines medication with lifestyle modifications.
Study on the Effects of AZD0780 on Cholesterol Levels in Adults Aged 18-75 with Dyslipidemia
This international trial, conducted across Slovakia, Spain, Denmark, Hungary, and Czechia, evaluates a new experimental medication called AZD0780 for treating dyslipidaemia.
Inclusion criteria: You must be between 18 and 75 years old and unable to have children. Your fasting LDL cholesterol must be between 70 mg/dL (1.8 mmol/L) and 190 mg/dL (4.9 mmol/L) at the start of the study. Your fasting triglycerides must be less than 400 mg/dL (4.52 mmol/L). You must have been taking moderate or high-intensity statin therapy for at least 2 months before the study with no planned changes in medication or dosage during the trial. Your body mass index must be 19.0 kg/m² or higher.
Exclusion criteria: You cannot participate if you have any serious medical condition interfering with the study, are pregnant or breastfeeding, participated in another trial within 30 days, have allergic reactions to the study medication, have uncontrolled high blood pressure, severe liver or kidney disease, history of drug or alcohol abuse, cannot follow study procedures, have history of heart disease like heart attack or stroke, or are taking medications that might interfere with the study drug.
Focus: The 12-week study evaluates how different doses of AZD0780 affect LDL cholesterol levels compared to placebo. Participants are randomly assigned to receive either the medication or placebo in a double-blind design. Regular follow-up visits include blood tests to measure cholesterol changes, vital signs assessment, and monitoring for side effects.
Investigational drugs: AZD0780 is an experimental lipid-lowering agent taken orally as a film-coated tablet. The medication targets specific pathways in the body to lower LDL cholesterol levels, though the exact mechanism is still under investigation.
Summary
These five clinical trials represent diverse approaches to managing dyslipidaemia across Europe. Hungary hosts the most trials with three studies, reflecting a concentration of cardiovascular research in this region. The trials range from comparing existing combination therapies to testing entirely new experimental medications.
Several trials focus on statin-based therapies, either alone or in combination with other drugs like fenofibrate. These established medications remain central to cholesterol management. However, newer approaches are also being investigated, including injectable therapies like RBD5044 and inclisiran, which represent different mechanisms of action compared to traditional oral statins.
Most studies target patients at high cardiovascular risk, particularly those with elevated LDL cholesterol despite existing treatment. The trials typically run between 12 weeks and 48 weeks, with regular monitoring of cholesterol levels and safety assessments. Several studies use advanced imaging techniques, such as CT angiography, to directly visualize changes in arterial plaque, providing objective measures of treatment effectiveness beyond blood test results.
Eligibility criteria across trials generally require stable existing therapy, specific cholesterol level thresholds, and exclude patients with severe organ dysfunction or recent cardiovascular events. These studies aim to provide evidence for better cholesterol management strategies and potentially expand treatment options for patients whose condition is not adequately controlled with current therapies.
