AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin compared with Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients

High cholesterol is a common condition that can increase the risk of heart attacks and strokes. This Phase 3 study is testing a new combined tablet that contains two medicines: rosuvastatin (a common cholesterol-lowering statin) and laroprovstat. The trial is designed for adults with high cholesterol who have not previously taken cholesterol-lowering treatments. The main goal is to find out if taking the two medicines together in one daily pill lowers "bad" cholesterol (known as LDL cholesterol) more effectively than taking rosuvastatin alone, laroprovstat alone, or an inactive dummy pill (a placebo). Participants will take their assigned tablets for eight weeks. During this time, doctors will monitor changes in their blood fat levels through routine blood tests. By comparing these treatments, researchers hope to see whether this new combination offers an improved, simpler treatment option.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

290

Start

05 Oct 2026

Hypercholesterolaemia

What is this study about?

Cholesterol is a fatty substance found in your blood. While your body needs some cholesterol to function properly, having too much "bad" cholesterol (called LDL cholesterol) can cause fatty deposits to build up in your blood vessels. Over time, this narrowing can raise your risk of heart disease and strokes. Doctors often prescribe statins to help lower cholesterol, but researchers continue to explore ways to make these treatments even more effective.

This study is testing a new treatment that combines two medicines into a single daily tablet: rosuvastatin and laroprovstat. Rosuvastatin is a well-known statin that helps your liver clear bad cholesterol from the bloodstream. Laroprovstat is an experimental medicine designed to work alongside it. Researchers want to find out whether taking both medicines together produces a greater drop in cholesterol than taking either medicine on its own.

Because this is a Phase 3 study, it is one of the final stages of research before a new medicine can be considered for general use. To ensure fair and reliable results, the study also includes a placebo (a dummy pill containing no active drug). Comparing the combined pill against the single drugs and a placebo helps doctors confirm that any improvements in cholesterol are genuinely caused by the new treatment and check that the medicine is safe to take.

Key takeaways

Tests a new 2-in-1 combination tablet containing rosuvastatin and laroprovstat.
Aimed at adults aged 18 and over with high cholesterol who have never taken cholesterol medication before.
Compares the combination pill against single medicines and an inactive placebo.
The main treatment period lasts for eight weeks.
Participation involves daily tablets, regular clinic visits, and routine blood tests.

Who may be eligible?

This trial is open to adults aged 18 and older of any sex who have high cholesterol (hypercholesterolaemia).

A key requirement is that participants must be "treatment-naïve." This means you should not have taken cholesterol-lowering medicines, such as statins, before. Researchers need to see how your body responds to the treatment without any previous cholesterol medications affecting the results.

Before you can take part, the study team will carry out health checks and blood tests to confirm your cholesterol levels and make sure the trial is safe for you. Certain other health conditions, allergies, or regular medications may mean you are unable to join.

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.

You are aged 18 or older.
You have been diagnosed with high cholesterol.
You have never taken cholesterol-lowering tablets (like statins) before.
You are able to take a daily tablet for at least eight weeks.
You are willing to attend clinic appointments and have routine blood tests.

Answer every question to see your result.

What does participation involve?

If you join the trial, your participation will last for at least eight weeks, alongside some extra time for initial health checks. You will be assigned to a treatment group by chance, similar to tossing a coin. You will receive either the combination tablet, rosuvastatin alone, laroprovstat alone, or a dummy pill (placebo). Neither you nor your study doctor will know which treatment you are receiving during the trial. You will take your study tablets once daily at home. You will also attend regular clinic visits where doctors will review your health, check your blood pressure, and take blood tests to measure your cholesterol levels and monitor for any side effects.

Potential risks and benefits

Taking part may help lower your cholesterol levels, and you will receive regular health checks and close medical supervision. However, there is no guarantee of direct health benefits, and you may be given an inactive dummy pill. As with any medication, there is a risk of side effects, such as muscle aches, upset stomach, or headaches. You are entirely free to leave the trial at any time and for any reason, and doing so will not affect your routine NHS care.

Locations (6)

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

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Unverified
Germany
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Unverified
Bulgaria
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Unverified
Hungary
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Unverified
Denmark
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Unverified
Poland
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Unverified
Spain

Common questions

What is a placebo?

A placebo is a dummy pill that looks identical to the real medicine but contains no active ingredients. It helps researchers check if the changes seen are truly caused by the study drug.

Will I know which medication I am receiving?

No. This is a "double-blind" study, which means neither you nor your study doctor will know which treatment you are taking until the study is finished. This ensures the results remain unbiased.

How long will the study last?

The main treatment phase lasts for eight weeks, with additional time beforehand for screening visits to confirm whether the study is suitable for you.

Do I have to pay to take part?

No. All study medications, tests, and medical appointments are provided free of charge. Travel expenses to and from the clinic are usually reimbursed.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can withdraw from the study at any point without giving a reason, and your normal healthcare will continue as usual.