AuthorisedTherapeutic use (Phase IV)Interventional

Studies to gain insight how the drugs PCSK9-inhibitors and statins affect cholesterol and bile acid metabolism

This research is looking for healthy men, aged 18 and older, to help understand how common cholesterol-lowering medicines work. Specifically, it's investigating two types of drugs: statins (like atorvastatin) and PCSK9 inhibitors (like evolocumab). Doctors want to learn how these medications change the way your body handles cholesterol and bile acids, which are important for digestion and fat absorption. By studying these changes, scientists hope to gain a clearer picture of how these drugs help to keep cholesterol levels healthy and how they might be used even more effectively in the future to prevent heart problems.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Karolinska University Hospital

Enrolment target

Start

12 Apr 2024

Healthy volunteers

What is this study about?

This study is designed to help us better understand some common medicines used to treat high cholesterol. High cholesterol can be a problem because it can lead to serious health issues like heart disease and strokes. The medicines being looked at are called statins (a well-known example is atorvastatin) and a newer type called PCSK9 inhibitors (like evolocumab).

Doctors want to see exactly how these drugs affect your body's systems. Specifically, they're interested in changes to your cholesterol and something called bile acid metabolism. Bile acids are substances made by your liver that help you digest fats. By understanding how these medicines interact with these systems, researchers can get a clearer picture of their full effects.

This research is important because the more we know about how medicines work, the better doctors can use them to help people. It could lead to better ways to treat high cholesterol and ultimately improve the health of many people in the future.

Key takeaways

This study helps understand how cholesterol drugs work.
It's for healthy men aged 18 and over.
You'll take statins or PCSK9 inhibitor drugs.
Participation involves clinic visits and blood tests.
Your contribution helps future patient care.

Who may be eligible?

To take part in this study, you need to be a healthy man and be 18 years old or older. This means they are not looking for people with existing health conditions that might affect the results of the study.

Because this study is very specific about how the body handles cholesterol and certain medications, it's only open to men. This helps the researchers get very clear results without other factors complicating the findings.

You won't be able to join if you have certain health problems or if you're taking medications that might interfere with the study drugs. The research team will do a thorough health check to make sure it's safe for you to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Are you generally in good health?
Are you not currently taking other interfering medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given specific medications – either evolocumab or atorvastatin – for a period. This study will involve several visits to the clinic where doctors will perform various assessments. These will likely include blood tests to measure your cholesterol levels and how your body is handling other substances like bile acids. You'll also have regular check-ups to monitor your overall health.

The research team will explain the exact schedule of visits and what each will involve. You'll also need to follow specific instructions regarding the medication and possibly your diet while in the study. The total duration of your involvement will be clearly outlined to you before you agree to participate.

Potential risks and benefits

Taking part in this study could offer several benefits, such as receiving expert medical monitoring and contributing to important research that helps advance our understanding of cholesterol-lowering drugs. However, like all medicines, evolocumab and atorvastatin can have side effects, which the study team will explain in detail. There might also be some discomfort from procedures like blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Sweden

Common questions

What is high cholesterol?

High cholesterol is when you have too much fatty substance in your blood, which can build up in your arteries and cause heart problems.

Are the medications safe?

The medications, atorvastatin and evolocumab, are approved for use and have been studied for safety. The research team will monitor you closely.

Will I get paid to participate?

Payment for participation varies by study. You should ask the research team if there is any compensation for your time and travel.

What are bile acids?

Bile acids are liquids made by your liver that help your body digest fats from the food you eat.

How long will the study last for me?

The exact duration of your involvement will be explained by the study team before you consent to participate.