A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
This research study is testing a new combination medicine called laroprovstat/rosuvastatin. It's designed for people who have high cholesterol but haven't yet started any cholesterol-lowering treatments. The main goal is to find out how well this new combination medicine lowers 'bad' cholesterol (LDL-C) and if it's safe to use. We'll be comparing it to taking laroprovstat by itself, rosuvastatin by itself, or a placebo (a dummy pill with no active medicine). This is a late-stage study (Phase 3), meaning the individual medicines have already been tested, and now we're looking at their combined effect in a larger group of people. The hope is to find a new, effective way to help manage high cholesterol.
At a glance
What is this study about?
This study is about finding better ways to help people manage high cholesterol, a common condition where there's too much fatty substance in your blood. High cholesterol can increase your risk of heart problems over time. Researchers are testing a new medicine that combines two active ingredients: laroprovstat and rosuvastatin. Rosuvastatin is a type of medicine called a statin, which is already used to lower cholesterol. Laroprovstat is a newer medicine being developed that also helps reduce the amount of 'bad' cholesterol (LDL-C) in your blood.
The main aim of this study is to see how well this new combination medicine works at lowering your LDL-C, which is often called 'bad' cholesterol because high levels can build up in your arteries. We also want to understand if it's safe and if people can take it without too many side effects. This is important because having more effective and convenient treatment options could help more people keep their cholesterol levels healthy.
This is a 'Phase 3' study, which means the medicines have already undergone earlier testing. Now, we're looking at them in a larger group of people to confirm their effectiveness and safety before they can potentially become available more widely. Participants will be given either the new combination medicine, one of the medicines by itself, or a placebo (a pill that looks like the real medicine but contains no active drug), to fairly compare their effects.
Key takeaways
- This study tests a new combination medicine for high cholesterol.
- It's for people who haven't taken cholesterol-lowering drugs recently.
- The goal is to see if the combination medicine safely lowers 'bad' cholesterol (LDL-C).
- You might receive the new medicine, individual components, or a dummy pill.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. We're looking for people who have high cholesterol but have never taken cholesterol-lowering medication before in the last three months. It's also important that you don't have a history of heart disease or blocked arteries, and your risk of developing these over the next 10 years is considered low.
There are certain reasons why you wouldn't be able to join. For example, if you've had problems taking statin medicines in the past, or if you have certain other health conditions that aren't well-controlled. These include severe high blood pressure, type 2 diabetes, or an underactive thyroid. The study also cannot include people of Asian origin.
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 18 years old or older?
- Do you have high cholesterol but haven't taken cholesterol medicine in the last 3 months?
- Have you never had heart disease or blocked arteries?
- Do you *not* have problems taking statin medicines?
- Are your blood pressure, diabetes, and thyroid conditions (if any) well-controlled?
- Are you *not* of Asian origin?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of several groups by chance. You might receive the new combination medicine, one of the medicines by itself, or a dummy pill (placebo). You won't know which one you're taking, nor will your study doctor, to ensure the results are fair.
You'll need to attend regular visits to the clinic for check-ups. During these visits, doctors and nurses will monitor your health, take blood samples to check your cholesterol levels, and ask you about any side effects you might be experiencing. They will also make sure you're taking the study medicine as prescribed. The total length of your participation in the study will be explained to you by the study team, including how long you'll be taking the medication and how many follow-up visits you'll need.
Potential risks and benefits
Locations (152)
- Research SiteVerified postcodeDothan, United States· Not yet recruiting
- Research SiteVerified postcodeChandler, United States· Not yet recruiting
- Research SiteVerified postcodePhoenix, United States· Not yet recruiting
- Research SiteVerified postcodeHuntington Beach, United States· Not yet recruiting
- Research SiteVerified postcodeLoma Linda, United States· Not yet recruiting
- Research SiteVerified postcodeLomita, United States· Not yet recruiting
- Research SiteVerified postcodeLong Beach, United States· Not yet recruiting
- Research SiteVerified postcodeSan Dimas, United States· Not yet recruiting
- Research SiteVerified postcodeArvada, United States· Not yet recruiting
- Research SiteVerified postcodeColorado Springs, United States· Recruiting
- Research SiteVerified postcodeWaterbury, United States· Not yet recruiting
- Research SiteVerified postcodeClearwater, United States· Not yet recruiting
Common questions
What is 'bad' cholesterol (LDL-C)?
'Bad' cholesterol, or LDL-C, is a type of fat in your blood. High levels can build up in your arteries, making them narrow and increasing your risk of heart problems.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the real study medicine but contains no active ingredients. It helps researchers compare the effects of the active medicine fairly.
What does 'LLT-naïve' mean?
This means you haven't taken any medicines to lower your cholesterol in the last three months before joining the study.
What is a 'Phase 3' study?
A Phase 3 study is a late stage of research where a new treatment is tested on a larger group of people to confirm its effectiveness, monitor side effects, and compare it with existing treatments.
Will I know which medicine I'm getting?
No, neither you nor your study doctor will know which treatment you are receiving. This is called 'blinding' and helps ensure the study results are unbiased.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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