Karolinska University Hospital
Solna, Sweden
Not yet recruiting
Study on How Evolocumab and Atorvastatin Affect Cholesterol and Bile Acid Metabolism in Healthy Volunteers
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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 understanding how the drugs evolocumab and atorvastatin affect the body's metabolism of cholesterol and bile acids. Cholesterol is a type of fat found in the blood, and bile acids are substances produced by the liver that help digest fats. The study involves healthy volunteers to explore these effects.
Evolocumab is a medication known as a PCSK9 inhibitor, which helps lower cholesterol levels by increasing the liver's ability to remove cholesterol from the blood. It is administered as a solution for injection under the skin. Atorvastatin is a type of drug called a statin, which is taken orally in tablet form. Statins work by reducing the amount of cholesterol produced by the liver.
The purpose of this study is to learn more about how these medications influence cholesterol and bile acid metabolism. Participants will receive either the medication or a placebo and will be monitored for changes in their cholesterol and bile acid levels over a period of time. This research aims to provide valuable insights into the effects of these drugs on the body's metabolic processes.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
3 criteria
- Participants must be healthy volunteers. This means they should not have any significant health issues.
- Participants must be 18 to 64 years old.
- Participants must be male.
Who cannot join the trial?
3 criteria
- Participants must be healthy volunteers. This means they should not have any significant health issues.
- Only male participants are allowed in this study.
- Participants must be within a specific age range. Please ensure you meet the age requirements.
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Investigated drugs
Atorvastatin
is a medication that belongs to a group of drugs called statins. It is used to lower cholesterol levels in the blood. By reducing cholesterol, atorvastatin helps prevent heart disease and stroke. In this clinical trial, researchers are studying how atorvastatin affects the way the body processes cholesterol and bile acids, which are substances that help digest fats.
Evolocumab
is a medication known as a PCSK9 inhibitor. It works by helping the liver remove more cholesterol from the blood, which can lower the risk of heart disease. In this study, evolocumab is being examined to understand its impact on cholesterol and bile acid metabolism in the body. This research aims to provide insights into how evolocumab can help manage cholesterol levels effectively.
What is already known about the treatment
Atorvastatin
Atorvastatin is a medication taken orally in the form of a tablet, commonly used to lower cholesterol levels in the blood. It is well-established in medical practice and literature as a treatment for high cholesterol and prevention of cardiovascular diseases. The main therapeutic use of atorvastatin is to reduce the risk of heart attacks and strokes by lowering bad cholesterol (LDL) and increasing good cholesterol (HDL). At the molecular level, atorvastatin works by inhibiting an enzyme in the liver responsible for producing cholesterol, thus reducing overall cholesterol levels. It belongs to a class of drugs known as statins, which are widely used for managing cholesterol.
Evolocumab
Evolocumab is administered via injection and is used to lower cholesterol levels, particularly in patients who have not responded adequately to statins alone. It is recognized in medical literature as an effective treatment for high cholesterol, especially in cases of familial hypercholesterolemia or when statins are not enough. Evolocumab works by blocking a protein called PCSK9, which leads to an increase in the number of receptors on liver cells that remove LDL cholesterol from the blood. This medication is classified as a PCSK9 inhibitor, a newer class of drugs for cholesterol management.
Investigated diseases
Healthy volunteers – This term refers to individuals who do not have any known medical conditions or diseases. They are often used in clinical trials to provide baseline data for comparison with individuals who have specific health conditions. Healthy volunteers typically have normal physiological functions and are not experiencing symptoms of illness. Their participation helps researchers understand the effects of new treatments or interventions in a controlled environment. The progression of health in these individuals is generally stable, as they do not exhibit disease-related changes. They serve as a control group to help identify the effects of the treatment being studied.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505726-34-02Estimated enrolment8 patientsSponsorKarolinska University Hospital
sourced from the EU Clinical Trials Register and site verification
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