Clinical Trials for Hyperlipidaemia
Currently, there are 2 ongoing clinical trials investigating treatments for hyperlipidaemia, a condition characterised by high levels of fats such as cholesterol in the blood. These trials are evaluating different cholesterol-lowering medications and their combinations, aiming to improve cardiovascular health outcomes in patients at varying risk levels. (Also known as: High cholesterol, Elevated blood lipids, Dyslipidemia)
Clinical trial locations
- Austria
- Croatia
- Germany
- Hungary
- Poland
- Slovenia
Study on the Effects of Alirocumab and Drug Combination on Hyperlipidemia in Patients
This clinical trial, conducted in Austria, is investigating how cholesterol-lowering medications affect various aspects of health beyond cholesterol levels. The study examines the relationship between these medications and steroid hormones, bile acids, muscle structure, vitamin D, the immune system, and related conditions such as depression and osteoporosis.
Who can participate:
- Adults aged between 18 and 75 years
- Individuals with LDL cholesterol levels above 116 mg/dl
- Most participants must have been previously prescribed treatment for high cholesterol, including high-dose statins such as atorvastatin at 40 mg or more, rosuvastatin at 20 mg or more, or PCSK-9 inhibitors like Praluent, Repatha, or Inclisiran
- A specific group of participants new to low-dose statin therapy with no previous statin history, who have been prescribed low-dose simvastatin, atorvastatin, or rosuvastatin
Who cannot participate:
- Individuals outside the age range of 18 to 65 years
- Vulnerable populations unable to give informed consent
Study focus: The main goal is to determine if cholesterol-lowering medications can reduce levels of steroid hormones in the body. Participants will be monitored for up to 36 months, during which they will receive one of several cholesterol-lowering medications or a placebo. The study will observe changes in sex steroid levels and assess how these medications might affect various bodily functions related to cholesterol management.
Investigational drugs: The trial involves several medications including alirocumab, rosuvastatin, evolocumab, atorvastatin, and inclisiran. Some medications are taken as tablets, while others are administered through injection under the skin. These drugs work by blocking substances the body needs to make cholesterol, helping to prevent heart attacks and strokes.
Study on Lowering Cholesterol with Rosuvastatin or Rosuvastatin/Ezetimibe in Patients at High or Very High Risk of Cardiovascular Disease with High Cholesterol
This international clinical trial is being conducted across five European countries: Hungary, Croatia, Poland, Slovenia, and Germany. The study focuses on comparing the effectiveness of two treatment approaches for lowering LDL cholesterol in patients at high or very high risk of cardiovascular disease.
Who can participate:
- Adults between 18 and 70 years old (at least 40 years old if apparently healthy or having type II diabetes without heart disease history)
- Individuals at high cardiovascular risk with LDL-C levels of 1.8 mmol/L (70 mg/dL) or higher, or at very high risk with levels of 1.4 mmol/L (55 mg/dL) or higher
- Those who have never received cholesterol-lowering treatment or have not been on such treatment for at least 4 weeks before joining the study
- Patients able to understand the trial information and provide voluntary informed consent
- Those capable of following the trial protocol without serious health conditions that could affect participation
Who cannot participate:
- Patients not at high or very high cardiovascular risk
- Those unable to achieve the required reduction in LDL cholesterol levels
- Individuals outside the specified age range
- Vulnerable populations
Study focus: The trial aims to evaluate how effective and safe these treatments are in achieving specific cholesterol level goals over 12 weeks. Participants are divided into two groups: one receiving rosuvastatin alone, and another receiving a combination of rosuvastatin and ezetimibe. The study monitors changes in cholesterol levels at 4, 8, and 12 weeks of treatment. The primary goal is to achieve at least a 50% reduction in LDL cholesterol from baseline levels.
Investigational drugs: Rosuvastatin works by reducing the amount of cholesterol made by the liver, helping to decrease the risk of heart disease and stroke. The combination of rosuvastatin and ezetimibe enhances cholesterol-lowering effects, as ezetimibe limits cholesterol absorption from the diet. Both treatments are taken orally as film-coated tablets in various dosages depending on group assignment.
Summary
These two clinical trials represent complementary approaches to understanding and treating high cholesterol levels. The first trial in Austria takes a comprehensive, long-term approach spanning up to 36 months, investigating not only cholesterol reduction but also the broader effects of various cholesterol-lowering medications on hormone levels, muscle health, and overall wellbeing. This study includes a diverse range of medications including both oral and injectable treatments.
The second trial, conducted across five European countries, takes a more focused approach over 12 weeks, specifically comparing the effectiveness of rosuvastatin alone versus the combination of rosuvastatin and ezetimibe in patients at high cardiovascular risk. The multi-country design of this trial provides a broader geographic representation and may help identify treatment effectiveness across different populations.
Both trials emphasise the importance of personalised treatment approaches based on cardiovascular risk levels and previous treatment history. They provide opportunities for patients who have not previously received cholesterol-lowering therapy, as well as those already on treatment regimens, to access potentially beneficial interventions while contributing to scientific understanding of cholesterol management.
