> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-5e5f32c2-ae57-4643-8e95-c187d7226004 > Record changed: 2026-10-13 # 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 NCT07000357 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) Participants 15,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) Start date 2025-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) Number of sites 1,452 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Title and summary **Summary** The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Acronym** AZURE-Outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Official title** A 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Dates **Completion date** 2029-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **First posted** 2025-06-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Primary completion date** 2029-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Start date** 2025-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Size and sites **Participants** 15,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Planned participants** 15,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Number of sites** 1,452 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Identifiers **Registry ID** NCT07000357 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **ClinicalTrials.gov ID** NCT07000357 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Placebo controlled **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Outcomes ### Primary outcomes 1. Time to first event of any component of MACE-PLUS Timeframe: Up 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) ### Secondary outcomes 1. Time to first event of any component of 3P MACE Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of 3-point (3P)-MACE (the composite of CV death, MI, and ischaemic stroke) 2. Time to first event of any component of MACE PLUS Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS in patients with a history of ASCVD 3. Time to first event of MI Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MI 4. Time to first event of urgent coronary revascularisation Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of urgent coronary revascularisation 5. Time to CV death Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of CV death 6. Time to first event of MALE Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of major adverse limb event (MALE) (the composite of acute lower limb ischaemia, major amputation of vascular aetiology, and urgent lower extremity revascularisation) 7. Time to all-cause mortality Timeframe: Up to approximately 54 months To compare the effect of treatment with AZD0780 to placebo in reducing the risk of all-cause mortality Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Meets one of the following: 1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening Additional risk factors based on the level of the LDL-C and timing of MI or stroke: o 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. ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD 2. 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), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with 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 at least one of the following end-organ diseases: 1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR < 60 mL/min/1.73 m2\. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening 2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist 3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist 4. ABI < 0.9 or > 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Sites - Research SiteAthens, United StatesRecruiting - Research SiteBirmingham, United StatesRecruiting - Research SiteBirmingham, United StatesNot yet recruiting - Research SiteFairhope, United StatesRecruiting - Research SiteFoley, United StatesRecruiting - Research SiteHuntsville, United StatesWithdrawn - Research SiteHuntsville, United StatesNot yet recruiting - Research SiteIrondale, United StatesNot yet recruiting - Research SiteMobile, United StatesRecruiting - Research SiteNorthport, United StatesNot yet recruiting - Research SiteSaraland, United StatesRecruiting - Research SiteVestavia Hills, United StatesRecruiting - Research SiteGilbert, United StatesNot yet recruiting - Research SiteGilbert, United StatesRecruiting - Research SiteGlendale, United StatesTerminated - Research SiteMesa, United StatesWithdrawn - Research SitePeoria, United StatesRecruiting - Research SitePhoenix, United StatesNot yet recruiting - Research SitePhoenix, United StatesRecruiting - Research SitePhoenix, United StatesRecruiting - Research SitePhoenix, United StatesRecruiting - Research SiteScottsdale, United StatesRecruiting - Research SiteTempe, United StatesRecruiting - Research SiteTucson, United StatesRecruiting - Research SiteTucson, United StatesWithdrawn And 1,427 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## References ### Other registry identifiers (2) - 2025 - 2025-520519-14 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07000357) ## Related records ### Drugs (1) - [Laroprovstat](https://trialight.com/data/asset/laroprovstat-66e6da5b-2260-456c-8dca-4a4b86359a87.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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