Active not recruitingPHASE3INTERVENTIONAL

A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event

This study is testing a new medication called AZD0780 to see if it can safely lower 'bad' cholesterol (LDL-C) in adults. It's for people who either already have heart and blood vessel disease (like after a heart attack or stroke), or those who are at a higher risk of getting it for the first time. AZD0780 is designed to reduce the amount of LDL-C in the blood. Some participants will receive AZD0780, while others will get a dummy pill (placebo). Neither you nor the study team will know which you're receiving until the study ends. We also want to make sure the drug is safe. The study lasts about 56 weeks per person.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

3,103

Start

28 May 2025

Estimated completion

11 Jan 2027

Cardiovascular Disease

What is this study about?

This study is looking into a new medication called AZD0780. We want to see if it can help lower 'bad' cholesterol, also known as LDL-C, in people who either already have heart and blood vessel disease or are at a higher risk of developing it. LDL-C is important because high levels can lead to problems like heart attacks and strokes. Many people already take medicines to lower their cholesterol, and this study will test if AZD0780, taken alongside these existing treatments, can improve things further.

Heart and blood vessel disease, sometimes called cardiovascular disease or ASCVD, includes conditions like having had a heart attack, stable or unstable angina (chest pain due to heart disease), or problems with blood flow to other parts of the body. Being at risk means you might have conditions like diabetes, high blood pressure, or chronic kidney disease, which increase your chances of developing these heart problems.

The main goal is to find out if AZD0780 is effective at lowering LDL-C and whether it is safe for people to use. It's a 'Phase III' study, which means it's one of the final steps in testing a new medicine before it might become widely available. Doctors and scientists are carefully reviewing the results as they come in to make sure everything is handled safely and correctly.

Key takeaways

This study tests a new drug (AZD0780) to lower 'bad' cholesterol (LDL-C).
It's for adults with existing heart disease or those at high risk of developing it.
You'll take the study medication for about a year, alongside your current cholesterol drugs.
Some participants get the new drug, others get a dummy pill (placebo).
The main goals are to check if AZD0780 is effective and safe.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must either have a history of heart and blood vessel disease (like a previous heart attack, specific types of chest pain, or procedures to open up blood vessels), or you must be at a higher risk of getting it for the first time.

Being at risk could mean you have certain conditions like diabetes, high blood pressure, or chronic kidney disease, or a significant narrowing of blood vessels. Importantly, your 'bad' cholesterol (LDL-C) levels must still be above a certain point, even if you are already taking other cholesterol-lowering medicines.

You should also already be on a stable dose of cholesterol-lowering medication. This might include a strong statin, or a weaker statin combined with other drugs like ezetimibe or bempedoic acid. The study team will check all these details to see if you're a good fit.

Quick self-check

Are you 18 years old or older?
Do you have a history of heart disease, or are you at high risk for it?
Is your 'bad' cholesterol (LDL-C) still high, even with your current medication?
Are you already taking stable cholesterol-lowering medication (like statins, ezetimibe, etc.)?

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, you'll first have a 'screening' period of up to 14 days where checks will be done to see if you meet all the study requirements. Once confirmed, you'll be randomly assigned to either receive the new drug AZD0780 or a dummy pill (placebo). There's an equal chance of getting either one, and neither you nor your doctors will know which you're receiving during the study.

You'll take the study medication once a day, by mouth, for 52 weeks (about one year), on top of your current cholesterol-lowering medicines. During this time, you'll have regular visits to the study clinic for health checks, blood tests, and to make sure you're doing well. After you finish taking the study medicine, there will be a final follow-up period of 10 days to check on your health and safety. The total time you'd be involved in the study is about 56 weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that AZD0780 might lower your 'bad' cholesterol more effectively than your current treatment, which could ultimately reduce your risk of heart problems. However, there's no guarantee you'll receive the active drug or that it will benefit you. Potential risks could include side effects from the medication, which would be explained in more detail by the study team. There's also the inconvenience of study visits and tests. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (404)

Research Site
Huntsville, United States
Research Site
Irondale, United States
Research Site
Mobile, United States
Research Site
Gilbert, United States
Research Site
Phoenix, United States
Research Site
Sun City West, United States
Research Site
Garden Grove, United States
Research Site
Gardena, United States
Research Site
Lancaster, United States
Research Site
Lincoln, United States
Research Site
San Diego, United States
Research Site
San Diego, United States

+392 more sites — see the official record for the full list.

Common questions

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

LDL-C stands for Low-Density Lipoprotein Cholesterol. It's often called 'bad' cholesterol because high levels can build up in your arteries and increase your risk of heart disease and stroke.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers understand if the new drug is truly making a difference or if any changes are due to other factors.

Why don't I know if I'm getting the drug or placebo?

This is a 'blinded' study. Not knowing helps ensure the results are accurate and unbiased, as expectations from either you or the doctors can't influence what happens during the study.

Can I continue my regular cholesterol medicine during the study?

Yes, you must continue your stable dose of existing cholesterol-lowering medicines as part of your background treatment during this study.

How long will I be involved in the study?

The total time you would be involved, including initial checks, taking the medicine, and follow-up, is about 56 weeks (just over a year).