Study on How Evolocumab and Atorvastatin Affect Cholesterol and Bile Acid Metabolism in Healthy Volunteers

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to understand how the drugs PCSK9 inhibitors and statins affect cholesterol and bile acid metabolism in the body.

2 initial assessment

An initial assessment will be conducted to ensure you meet the criteria for participation. This includes confirming that you are a healthy male volunteer aged between 18 and 64 years.

3 medication administration

You will receive two types of medications during the trial: evolocumab and atorvastatin.

Evolocumab will be administered through a subcutaneous injection. This means the medication will be injected under your skin.

Atorvastatin will be taken orally, which means you will swallow the medication in the form of a pill.

4 medication schedule

The specific dosage, frequency, and duration of the medication administration will be explained to you by the study team. It is important to follow the instructions provided to ensure the accuracy of the study results.

5 monitoring and follow-up

Throughout the study, your health and the effects of the medications on your cholesterol and bile acid metabolism will be monitored. This may involve regular check-ups and tests as determined by the study protocol.

6 completion of the study

The study is expected to end by December 31, 2024. Upon completion, the results will be analyzed to understand the changes in cholesterol and bile acid metabolism due to the medications.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
01.02.2024

Trial locations

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.

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 ID:
2023-505726-34-02
NCT ID:
NCT06140095
Trial Phase:
Therapeutic confirmatory (Phase III)

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