Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-30 @ 4:58 PM
Study NCT ID:
NCT07000357
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group, event-driven'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-10-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first event of any component of MACE-PLUS', 'timeFrame': 'Up to approximately 54 months', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Time to first event of any component of 3P MACE', 'timeFrame': 'Up to approximately 54 months', 'description': '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)'}, {'measure': 'Time to first event of any component of MACE PLUS', 'timeFrame': 'Up to approximately 54 months', 'description': 'To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MACE-PLUS in patients with a history of ASCVD'}, {'measure': 'Time to first event of MI', 'timeFrame': 'Up to approximately 54 months', 'description': 'To compare the effect of treatment with AZD0780 to placebo in reducing the risk of MI'}, {'measure': 'Time to first event of urgent coronary revascularisation', 'timeFrame': 'Up to approximately 54 months', 'description': 'To compare the effect of treatment with AZD0780 to placebo in reducing the risk of urgent coronary revascularisation'}, {'measure': 'Time to CV death', 'timeFrame': 'Up to approximately 54 months', 'description': 'To compare the effect of treatment with AZD0780 to placebo in reducing the risk of CV death'}, {'measure': 'Time to first event of MALE', 'timeFrame': 'Up to approximately 54 months', 'description': '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)'}, {'measure': 'Time to all-cause mortality', 'timeFrame': 'Up to approximately 54 months', 'description': 'To compare the effect of treatment with AZD0780 to placebo in reducing the risk of all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atherosclerotic Cardiovascular Disease'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets one of the following:\n\n 1. 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\n\n Additional risk factors based on the level of the LDL-C:\n * 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.\n\n 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\n 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) and diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n 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\n\nFor (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n1. CKD with eGFR x mL/min/1.73 m2\n2. Current tobacco use\n3. Age ≥ 65\n4. T2DM (if included on the less significant atherosclerosis criterion iii)\n\n * 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).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* 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.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\< 15 mL /min/1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n * AST or ALT \\> 3 × ULN\n * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\< 1.5 × ULN)\n * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L).\n * Creatine kinase \\> 5 × ULN\n * Urine albumin/creatinine ratio ≥ 500 mg/g\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* 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.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* 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."}, 'identificationModule': {'nctId': 'NCT07000357', 'acronym': 'AZURE-Outcomes', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D7960C00015'}, 'secondaryIdInfos': [{'id': '2025-520519-14', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD0780', 'description': 'Participants will receive oral AZD0780 once daily', 'interventionNames': ['Drug: AZD0780']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive oral placebo once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD0780', 'type': 'DRUG', 'description': 'Participants will receive oral AZD0780 once daily', 'armGroupLabels': ['AZD0780']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive oral placebo once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36532', 'city': 'Fairhope', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36571', 'city': 'Saraland', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.82074, 'lon': -88.07056}}, {'zip': '35216', 'city': 'Vestavia Hills', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44872, 'lon': -86.78777}}, {'zip': '85296', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 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