RecruitingPHASE3INTERVENTIONAL

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

This research study is testing a new medication, AZD0780, to see if it can help prevent serious heart and blood vessel problems. We want to know if AZD0780 can reduce the chances of things like heart attacks, strokes, or needing procedures to unblock arteries. We're looking for two groups of people: those who have already experienced such events, and those who haven't had one yet but are at high risk. The study will compare AZD0780 to a dummy pill (placebo) to understand its effects. This is a "phase 3" study, which means it’s one of the final steps to determine if this new medicine is safe and effective enough for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

15,100

Start

04 Jun 2025

Estimated completion

26 Oct 2029

Cardiovascular Disease

What is this study about?

This study is investigating a new medicine called AZD0780. We know that heart disease and strokes are major health concerns, and researchers are always looking for better ways to prevent them. This particular medicine is designed to work in a specific way to help control factors that contribute to these problems. By participating, you could help us understand if AZD0780 is a good option for protecting people's hearts and blood vessels in the future.

The main goal of the study is to see if AZD0780 can lower the risk of serious health events related to your heart and blood vessels. These events, sometimes called 'MACE-PLUS', include things like heart attacks, strokes, or even the need for surgery or other procedures to clear blocked arteries. We're interested in people who have already had these kinds of problems, as well as those who haven't but are considered to be at a high risk of developing them soon.

This is a 'phase 3' study, which means it's a large and important step in developing new medicines. We're comparing AZD0780 to a 'placebo' (a dummy pill that looks like the study drug but contains no active medicine). This helps us make sure that any improvements we see are truly due to AZD0780 and not just other factors. Your participation is vital in helping us find out if this new medicine could offer a new way to keep hearts healthier.

Key takeaways

This study is testing a new medicine (AZD0780) for heart and blood vessel problems.
It aims to reduce the risk of future heart attacks, strokes, or related procedures.
The study includes people who have had these problems or are at high risk.
Participants will receive either the study medicine or a dummy pill.
Regular health checks are part of participating.
You can stop taking part at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 and over. We are interested in two main groups of people.

Firstly, we are looking for those who have already had a heart attack, an ischaemic stroke (a stroke caused by a blood clot), or surgery to help blood flow in their legs due to blocked arteries. For this group, your 'bad' cholesterol (LDL-C) level needs to be at a certain level, and you might also need to have other health conditions like type 2 diabetes, be aged 65 or older, have had a foot or lower leg amputation, or have certain kidney problems.

Secondly, we are looking for people who haven't had a heart attack, stroke, or leg surgery but are at a higher risk of having one. This includes men aged 50 or over, or women aged 55 or over, who also have a certain 'bad' cholesterol level. Additionally, they must have clear signs of artery disease, or have high-risk type 1 or type 2 diabetes that is affecting their kidneys, eyes, or nerves.

Quick self-check

Are you 18 years of age or older?
Have you had a heart attack, certain types of stroke, or leg artery surgery in the past?
Do you have high 'bad' cholesterol (LDL-C) and other risk factors like diabetes or kidney issues?
Or, are you a man aged 50+ or woman aged 55+ with high 'bad' cholesterol and signs of artery or high-risk diabetes?
Have you been diagnosed with conditions affecting your kidneys, eyes, or nerves due to diabetes?
Are you able to attend regular clinic visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive the study medication (AZD0780) or a placebo (a dummy pill). You wouldn't know which one you're receiving, and neither would your study doctor. You would take the medication daily for the duration of the study.

Throughout the study, you'll have regular visits to the clinic where the medical team will monitor your health, conduct examinations, take blood samples, and ask about your general well-being and any side effects. The study will continue until enough data has been collected to answer the research questions, and your final visit would be scheduled after that. The total time you would be involved will depend on how long it takes to gather all the necessary information from all participants.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might benefit from closer medical monitoring and access to a new medication not yet widely available. However, there's always a chance the treatment won't help you, or you might experience side effects from the study medication. These will be carefully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1333)

Research Site
Athens, United States· Not yet recruiting
Research Site
Birmingham, United States· Recruiting
Research Site
Fairhope, United States· Recruiting
Research Site
Foley, United States· Recruiting
Research Site
Huntsville, United States· Suspended
Research Site
Mobile, United States· Recruiting
Research Site
Mobile, United States· Not yet recruiting
Research Site
Saraland, United States· Recruiting
Research Site
Vestavia Hills, United States· Recruiting
Research Site
Gilbert, United States· Recruiting
Research Site
Glendale, United States· Recruiting
Research Site
Mesa, United States· Suspended

+1321 more sites — see the official record for the full list.

Common questions

What is 'ASCVD'?

ASCVD stands for Atherosclerotic Cardiovascular Disease. It's a type of heart disease where plaque builds up in your arteries, which can lead to heart attacks and strokes.

What does 'randomised, placebo-controlled' mean?

It means you have an equal chance of getting the real study medicine or a dummy pill, decided by chance. Neither you nor the doctors will know which one you're taking.

What is a 'phase 3' study?

Phase 3 is an important stage of drug development where a new medicine is tested on a large group of people to confirm its effectiveness, monitor side effects, and compare it to existing treatments.

What is 'LDL-C'?

LDL-C is often called 'bad cholesterol'. High levels can increase your risk of heart disease.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your regular medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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