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AZD0780 for Cardiovascular Disease

This study is testing a new oral medicine called AZD0780 to see if it can lower the risk of serious heart problems (Major Adverse Cardiovascular Events, or MACE-PLUS) in people who have already had heart disease or are at high risk for it. You would take AZD0780 or a placebo (a pill with no medicine) once a day. The study aims to see if AZD0780 is better than placebo at preventing these heart problems over about 54 months. We are looking for adults aged 18 and older who have a history of certain heart events like a heart attack or stroke, or who are at high risk for them. The study is currently recruiting many participants.

Study design
This is a Phase 3, randomized, placebo-controlled study involving about 15,100 participants. You would be randomly assigned to receive either AZD0780 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to approximately 54 months to track the occurrence of MACE-PLUS events.

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NCT07000357

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~15,100 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:AZD0780Placebo

At a glance

Recruiting sites
1106 of 1452 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first event of any component of MACE-PLUS
Measured over Up to approximately 54 months

Conditions

Cardiovascular Disease

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Where it's being run

1452 sites across 85 states
China122
Germany118
Japan108
Florida51
Brazil42
Texas39
United Kingdom36
India35

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Meets one of the following:
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).

Exclusion

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.
Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
Calculated eGFR \< 15 mL /min/1.73 m2 at screening.
Any laboratory values with the following deviations at screening:
AST or ALT \> 3 × ULN
TBL \> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L).
Creatine kinase \> 5 × ULN
Urine albumin/creatinine ratio ≥ 500 mg/g
Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.
Inadequately treated hypothyroidism defined as TSH \> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.
Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.
Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

What this trial measures

  • Time to first event of any component of MACE-PLUSUp to approximately 54 months

    To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS (the composite of CV death, myocardial infarction \[MI\], ischaemic stroke, acute lower limb ischaemia, major amputation of a vascular aetiology, and urgent arterial revascularisation)