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RecruitingOBSERVATIONAL

A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

This study is checking how a combination of three medicines works when given together to lower high cholesterol. The three medicines are bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. These medicines are already used to help people with high cholesterol or a mix of unhealthy fats in their blood. The main aim is to see how much this 'triple therapy' lowers 'bad' cholesterol (called LDL-C) after 8 weeks and then after a year. Researchers will also look at safety, whether patients achieve their cholesterol goals, and how consistently people take their medicines. This study observes people already taking these medicines, so no new drugs are given as part of the study itself.

At a glance

Status
Recruiting
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Enrolment target
2,000
Start
12 Feb 2025
Estimated completion
31 Jan 2028

What is this study about?

This study is all about understanding how well a specific combination of medicines works to lower high cholesterol in real-life situations. Doctors often prescribe more than one medicine to help people with high cholesterol, especially if their 'bad' cholesterol (known as LDL-C) is still too high even after taking one treatment.

The three medicines being looked at together are bempedoic acid, ezetimibe, and a statin (either rosuvastatin or atorvastatin). These are all established treatments for lowering cholesterol. The study aims to see how much this 'triple therapy' can bring down LDL-C levels. It will also track how many people reach their cholesterol targets and if there are any side effects over time. This information helps doctors understand the best ways to manage high cholesterol and improve patient health.

It's important to know that this is an ‘observational study’. This means the researchers are simply observing and collecting information from people who are already being treated with these medicines by their doctors. No new medicines will be given by the study team, and your current treatment will not change because of your participation. They are keen to learn from everyday medical practice.

Key takeaways

  • This study observes people taking three common cholesterol medications together.
  • It aims to understand how well this 'triple therapy' lowers 'bad' cholesterol (LDL-C) in real life.
  • Researchers will also track safety and if people meet their cholesterol goals.
  • No new medicines are given; information is collected from your existing medical care.
  • Participation lasts for about one year, looking at information at 8 weeks and 1 year.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with high cholesterol or a mix of unhealthy blood fats by your doctor. You must also be considered at high or very high risk for heart problems.

This study is for people who have recently started taking the specific combination of three medicines: bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. You might have started all three medicines at the same time, or bempedoic acid was added to your existing statin and ezetimibe, or ezetimibe was added to your existing statin and bempedoic acid.

There are also a few things that would mean you can't join. For example, if you've recently used certain other cholesterol-lowering treatments called PCSK9i monoclonal antibodies or ever used PCSK9i-siRNA, you wouldn't be eligible. Your doctor will carefully check if this study is right for you, making sure there are no reasons from your medical history that would prevent you from taking part.

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.

  1. Are you 18 years or older?
  2. Do you have high cholesterol or a mix of unhealthy blood fats?
  3. Have you recently started taking bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin together?
  4. Has your doctor said you are at high or very high risk for heart problems?
  5. Have you not recently taken certain other advanced cholesterol-lowering injections (PCSK9i treatments)?
Answer every question to see your result.

What does participation involve?

This is an observational study, which means you won't be given any new drugs by the research team. You will continue to take the medicines your doctor has prescribed for your cholesterol (bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin) as part of your usual care. The study involves collecting information from your routine clinic visits and medical records over a period of one year. This will include your cholesterol levels, other blood test results, and any side effects you might experience. It also looks at how consistently you take your medicines. There will be specific checks at 8 weeks and again at 1 year from when you started the triple therapy.

Potential risks and benefits

Participating in this study means that your routine medical information will help researchers understand how effective and safe this combination of cholesterol medicines is in real-world use. This could lead to better treatments for more people in the future. As no new treatments are given, the risks are generally low, focusing on data collection rather than experimental procedures. However, taking any medication always carries potential side effects, which your doctor will discuss with you. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (163)

  • Innere Medizin
    Verified postcode
    Braunau am Inn, Austria· Recruiting
  • Innere Medizin 1
    Verified postcode
    Feldkirch, Austria· Recruiting
  • Uniklinik Graz, Endokrinologie und Diabetes
    Verified postcode
    Graz, Austria· Recruiting
  • Uniklinik Graz, Kardiologie
    Verified postcode
    Graz, Austria· Recruiting
  • Innere Medizin 3 - Kardiologie
    Verified postcode
    Innsbruck, Austria· Recruiting
  • Klinikum Wels-Grieskirchen GmbH+B18
    Unverified
    Kepler Universitätsklinikum Gmb+, Austria· Active not recruiting
  • Innere Medizin
    Verified postcode
    Klagenfurt, Austria· Recruiting
  • Innere Medizin
    Verified postcode
    Linz, Austria· Recruiting
  • Kepler Universitätsklinikum GmbH Klinik für Innere Medizin 1 - Kardiologie und Internistische Intensivmedizin
    Verified postcode
    Linz, Austria· Recruiting
  • Kardiologie-Urfahr Dr. Hönig & Dr. Gammer & Dr. Buchmayr
    Verified postcode
    Linz, Austria· Recruiting
  • Ordination
    Verified postcode
    Mattersburg, Austria· Recruiting
  • Landesklinikum Mistelbach - Gänserndorf
    Verified postcode
    Mistelbach, Austria· Active not recruiting

Common questions

What is 'bad' cholesterol (LDL-C)?

LDL-C stands for Low-Density Lipoprotein Cholesterol, often called 'bad' cholesterol because high levels can lead to plaque buildup in your arteries, increasing your risk of heart problems.

What does 'triple therapy' mean?

Triple therapy in this study refers to taking three specific medicines together: bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin, to help lower cholesterol.

Will I receive new medicine if I join this study?

No, this is an observational study. You will continue to take the medicines your doctor has already prescribed for you; the study team will just collect information about how you are doing.

How long will I be followed in this study?

The study will collect information from your medical records for up to one year after you started your triple therapy treatment.

What is 'primary hypercholesterolemia' or 'mixed dyslipidemia'?

These are medical terms for types of high cholesterol or unhealthy levels of fats (lipids) in your blood. Your doctor can explain which one you have.

How to find out more

Daiichi Sankyo Contact for Clinical Trial Information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Bempedoic Acid in Combination With Ezetimibe and …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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