Recruiting

AZURE-OutcomesAZD0780 for Reducing Cardiovascular Events in Atherosclerotic Disease

What is being tested

AZD0780

+ Placebo

Drug

Who is being recruted

Arterial Occlusive Diseases+2

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: June 2025

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 4, 2025

Actual date on which the first participant was enrolled.

This study is investigating the effectiveness of a new medication called AZD0780 in reducing serious heart-related events in people who have atherosclerotic cardiovascular disease (ASCVD) or are at high risk of developing it. ASCVD is a condition where the arteries become narrowed or blocked due to plaque buildup, leading to potential heart attacks or strokes. The study is important because finding effective treatments can help prevent these life-threatening events and improve the quality of life for many individuals who are at risk. Participants in this study will be randomly assigned to take either the AZD0780 medication or a placebo, which is a substance with no active medication, to compare its effects. The medication is taken orally, meaning it is swallowed like a pill. The study will measure how well AZD0780 works by tracking the occurrence of major cardiovascular events from the start of the study until a specified end date. There are no details given about potential risks or benefits, but participants will have a final visit after the study ends to assess their health.

Official TitleA Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

15100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesAtherosclerosis

Criteria

4 inclusion criteria required to participate

Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of ASCVD defined as ACS ≥ 1 month to ≤ 12 months prior to randomisation, ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month to ≤ 12 months prior to randomisation, or revascularisation for symptomatic lower limb PAD any time prior to screening Additional risk factors based on the level of the LDL-C: * Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below. i) T2DM requiring ongoing medical therapy ii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD

Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) and diagnostic evidence of at least one of the following disease categories (i, ii, or iii): i) Significant atherosclerotic artery disease ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of end-organ disease (diabetic nephropathy, retinopathy, neuropathy or an ABI outside the normal range \[0.9 to 1.4\]) iii) Documented atherosclerosis of less significance For (ii) and (iii), participants need to have at least one of the additional risk factors below: 1. CKD with eGFR x mL/min/1.73 m2 2. Current tobacco use 3. Age ≥ 65 4. T2DM (if included on the less significant atherosclerosis criterion iii)

Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).

Participants must achieve a stable background lipid lowering therapy > 28 days before screening.

10 exclusion criteria prevent from participating

Calculated eGFR < 15 mL /min/1.73 m2 at screening.

Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.

Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.

Any revascularisation procedure planned within the next 3 months.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants will receive oral AZD0780 once daily

Group II

Placebo

Participants will receive oral placebo once daily

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1,201 locations

Recruiting

Research Site

Beijing, ChinaOpen Research Site in Google Maps

Recruiting

Research Site

Changchun, China

Recruiting

Research Site

Changde, China

Recruiting

Research Site

Changsha, China

Recruiting

1,201 Study Centers