Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIb, Multicenter, Randomized, Parallel-group, Double- blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AZD0780 in Participants with Dyslipidemia

This research study is testing a new medicine, AZD0780, for people who have unhealthy levels of fats in their blood, also known as dyslipidemia. This often means having high levels of 'bad' cholesterol (LDL-C), which can lead to serious heart conditions like heart attacks and strokes. These heart problems are a major cause of illness and death worldwide. The study will look at how well AZD0780 lowers these unhealthy blood fats over 12 weeks, and if it is safe and tolerable to take. Some participants will receive the active medicine, while others will receive a placebo (a dummy pill) to compare the effects fairly.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Astrazeneca AB

Enrolment target

209

Start

16 Jan 2024

which is a major risk factor for Cardiovascular Disease (CVD)such as Ischemic Heart Disease and Ischemic Stroke. CVD is a leading cause of global mortality and a contributor to disability.

What is this study about?

This study is about a health condition called dyslipidemia, which simply means having unhealthy levels of fats in your blood. A very common type of dyslipidemia is having high cholesterol, especially too much 'bad' cholesterol, known as LDL-cholesterol. This bad cholesterol is a major factor that can increase your risk of heart and blood vessel problems, such as heart attacks and strokes. These conditions, known as cardiovascular diseases, are a significant health concern globally.

We are testing a new medicine called AZD0780. The main aim is to see if this medicine can effectively lower these unhealthy fats in your blood, particularly the 'bad' LDL-cholesterol, over a period of 12 weeks. We will also be looking at how this new medicine affects other types of fats, like good cholesterol (HDL-C) and triglycerides, as well as checking inflammatory markers.

This is a 'Phase II' study, which means we are exploring how well the medicine works and also paying close attention to its safety. By understanding how AZD0780 affects cholesterol and other blood fats, we hope to find new ways to help people manage their risk of heart problems and strokes.

Key takeaways

This study tests a new medicine (AZD0780) for unhealthy blood fats.
It aims to lower 'bad' cholesterol (LDL-C) and other fats.
Participants will receive either the medicine or a dummy pill (placebo).
It's a main phase (Phase II) study focusing on how well it works and safety.
The study involves regular visits, blood tests, and health checks over 12 weeks.
Ultimately, the goal is to help reduce the risk of heart attacks and strokes.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. Both men and women are welcome to take part.

Beyond this basic age requirement, the study will have specific health criteria to ensure it's suitable for you. For instance, you would need to have certain levels of cholesterol or other fats in your blood that the study is designed to treat. The study team will check your medical history and conduct tests to make sure you fit the precise health profile needed for this research.

It's important that you don't have any other medical conditions that might interfere with the study medicine or the planned tests. Your doctor and the study team will go through all the details to determine if this study is the right fit for you.

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 or other unhealthy blood fat levels?
Are you able to attend regular study appointments?
Are you willing to take the study medicine or placebo for 12 weeks?
Are you comfortable with blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either the new medicine AZD0780 or a placebo (a dummy pill that looks the same but contains no active medicine). Neither you nor your study doctor will know which one you are taking until the end of the study. This is called 'double-blind' and helps ensure fair results.

You will need to attend several appointments over a 12-week period. During these visits, the study team will take blood samples to check your cholesterol and other fat levels, as well as monitor the medicine's levels in your body. We will also perform physical exams, check your vital signs (like blood pressure and heart rate), take ECGs (heart rhythm tests), and carry out other safety lab tests.

After the 12 weeks, there will be follow-up checks to make sure you are well and to gather all the necessary information. The total duration of your involvement, including follow-up, will be explained fully by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. Potential benefits might include closer monitoring of your health and access to a new medicine that could help manage your cholesterol, possibly before it's widely available. However, there's no guarantee you will receive the active medicine or that it will help your condition. Potential risks could include side effects from the medicine, or discomfort from blood tests and other procedures. All possible side effects will be fully explained. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Denmark
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Unverified
Czechia
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Unverified
Spain
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Unverified
Slovakia
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Unverified
Hungary

Common questions

What is dyslipidemia?

Dyslipidemia means you have unhealthy levels of fats, like cholesterol, in your blood. This can include having too much 'bad' cholesterol or not enough 'good' cholesterol.

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

LDL-cholesterol is often called 'bad' cholesterol because high levels can lead to a build-up of fatty deposits in your arteries, increasing your risk of heart disease and stroke.

What is a 'placebo'?

A placebo is a dummy pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare the effects of the new medicine fairly.

How long will the study last for me?

The main part of the study will involve taking the medicine or placebo for 12 weeks, followed by further checks. The study team will tell you the exact total duration.

Will I know if I'm getting the real medicine?

No, you won't know if you're getting the active medicine or the placebo. This is to ensure the study results are as accurate and unbiased as possible.