Recruiting
Phase 3

AZD0780

Sponsor:

AstraZeneca

Code:

NCT07000357

Conditions

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD0780

Placebo

Study Details

Brief 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.

Conditions

Cardiovascular Disease

Study ID

NCT07000357

Start date

Jun 4, 2025

Status verified date

Aug, 2026

Completion date

Oct 26, 2029

Anticipated

Primary completion date

Oct 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

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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.

Study Design

Enrollment

15100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD0780

Participants will receive oral AZD0780 once daily

placebo comparator: Placebo

Participants will receive oral placebo once daily

Interventions

AZD0780

Participants will receive oral AZD0780 once daily

Placebo

Participants will receive oral placebo once daily

Primary outcome measure

  • Time to first event of any component of MACE-PLUS [ Time Frame: Up to approximately 54 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

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Athens, Alabama, United States, 35611

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Birmingham, Alabama, United States, 35205

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Fairhope, Alabama, United States, 36532

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Foley, Alabama, United States, 36535

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Mobile, Alabama, United States, 36608

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Saraland, Alabama, United States, 36571

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Vestavia Hills, Alabama, United States, 35216

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Gilbert, Arizona, United States, 85296

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Peoria, Arizona, United States, 85382

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Phoenix, Arizona, United States, 85014

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Phoenix, Arizona, United States, 85051

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Phoenix, Arizona, United States, 85053

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Scottsdale, Arizona, United States, 85260

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Tempe, Arizona, United States, 85283

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Tucson, Arizona, United States, 85715

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Tucson, Arizona, United States, 85745

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Little Rock, Arkansas, United States, 72205

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Beverly Hills, California, United States, 90211

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Canoga Park, California, United States, 91303

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Castroville, California, United States, 95012

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Chula Vista, California, United States, 91911

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Fountain Valley, California, United States, 92708

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Garden Grove, California, United States, 92844

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Lancaster, California, United States, 93534

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Loma Linda, California, United States, 92350

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Loma Linda, California, United States, 92357

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Los Angeles, California, United States, 90017

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Los Angeles, California, United States, 90035

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Lynwood, California, United States, 90262

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Monterey Park, California, United States, 91754

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Newport Beach, California, United States, 92663

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Norco, California, United States, 92860

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Northridge, California, United States, 91325

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Pomona, California, United States, 91768

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Riverside, California, United States, 92503

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San Diego, California, United States, 92111

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San Dimas, California, United States, 91773

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Tarzana, California, United States, 91356

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Thousand Oaks, California, United States, 91360

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Torrance, California, United States, 90502

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West Hills, California, United States, 91307

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Waterbury, Connecticut, United States, 06708

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Clearwater, Florida, United States, 33756

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Coral Gables, Florida, United States, 33134

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Crystal River, Florida, United States, 34429

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DeLand, Florida, United States, 32720

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Fleming Island, Florida, United States, 32003

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Fort Lauderdale, Florida, United States, 33308

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Hallandale, Florida, United States, 33009

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Hialeah, Florida, United States, 33012

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Hollywood, Florida, United States, 33021

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Homestead, Florida, United States, 33030

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Jacksonville, Florida, United States, 32216

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Lake City, Florida, United States, 32055

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Lake Worth, Florida, United States, 33462

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Lakeland, Florida, United States, 33805

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Lakeland, Florida, United States, 33813

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Largo, Florida, United States, 33777

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Longwood, Florida, United States, 32750

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Maitland, Florida, United States, 32751

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Margate, Florida, United States, 33063

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Miami, Florida, United States, 33176

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Miami, Florida, United States, 33186

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Miami, Florida, United States, 33269

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Miami Lakes, Florida, United States, 33014

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Miami Lakes, Florida, United States, 33016

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Naples, Florida, United States, 34102

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New Port Richey, Florida, United States, 34652

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New Port Richey, Florida, United States, 34653

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Ocala, Florida, United States, 34470

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Orlando, Florida, United States, 32801

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Orlando, Florida, United States, 32807

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Orlando, Florida, United States, 32825

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Palm Harbor, Florida, United States, 34684

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Pembroke Pines, Florida, United States, 33029

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Port Charlotte, Florida, United States, 33952

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Safety Harbor, Florida, United States, 34695

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Saint Augustine, Florida, United States, 32086

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Seminole, Florida, United States, 33777

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Tampa, Florida, United States, 33625

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West Palm Beach, Florida, United States, 33401

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Atlanta, Georgia, United States, 30322

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Atlanta, Georgia, United States, 30328

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Atlanta, Georgia, United States, 30342

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Canton, Georgia, United States, 30114

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Decatur, Georgia, United States, 30030

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Decatur, Georgia, United States, 30033

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Hinesville, Georgia, United States, 31313

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Macon, Georgia, United States, 31210

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Riverdale, Georgia, United States, 30274

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Tucker, Georgia, United States, 30084

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Union City, Georgia, United States, 30291

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Chicago, Illinois, United States, 60607

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Gurnee, Illinois, United States, 60031

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Melrose Park, Illinois, United States, 60160

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Tinley Park, Illinois, United States, 60477

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Winfield, Illinois, United States, 60190

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Evansville, Indiana, United States, 47714

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Evansville, Indiana, United States, 47715

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Indianapolis, Indiana, United States, 46202

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Ames, Iowa, United States, 50010

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Waterloo, Iowa, United States, 50701

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West Des Moines, Iowa, United States, 50266

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Kansas City, Kansas, United States, 66112

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Kansas City, Kansas, United States, 66160

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Bowling Green, Kentucky, United States, 42101

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Lexington, Kentucky, United States, 40503

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Owensboro, Kentucky, United States, 42301

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Owensboro, Kentucky, United States, 42303

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Paducah, Kentucky, United States, 42001

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Versailles, Kentucky, United States, 40383

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Covington, Louisiana, United States, 70433

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Hammond, Louisiana, United States, 70403

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Lake Charles, Louisiana, United States, 70601

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Shreveport, Louisiana, United States, 71105

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Zachary, Louisiana, United States, 70791

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Bangor, Maine, United States, 04401

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Scarborough, Maine, United States, 04074

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Annapolis, Maryland, United States, 21401

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Baltimore, Maryland, United States, 21229

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Beltsville, Maryland, United States, 20705

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Columbia, Maryland, United States, 21044

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Lanham, Maryland, United States, 20706

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Oxon Hill, Maryland, United States, 20745

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Pikesville, Maryland, United States, 21208

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Salisbury, Maryland, United States, 21801

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Boston, Massachusetts, United States, 02111

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Brookline, Massachusetts, United States, 02446

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Dearborn Heights, Michigan, United States, 48127

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Farmington Hills, Michigan, United States, 48336

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Southfield, Michigan, United States, 48076

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Duluth, Minnesota, United States, 55805

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Minneapolis, Minnesota, United States, 55423

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Minneapolis, Minnesota, United States, 55435

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Saint Cloud, Minnesota, United States, 56303

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Bridgeton, Missouri, United States, 63044

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Chesterfield, Missouri, United States, 63005

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Hazelwood, Missouri, United States, 63042

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Jefferson City, Missouri, United States, 65109

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Kansas City, Missouri, United States, 64111

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Kansas City, Missouri, United States, 64151

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Springfield, Missouri, United States, 65807

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Missoula, Montana, United States, 59808

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Elkhorn, Nebraska, United States, 68022

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Fremont, Nebraska, United States, 68025

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Las Vegas, Nevada, United States, 89102

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Las Vegas, Nevada, United States, 89119

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Las Vegas, Nevada, United States, 89128

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Lebanon, New Hampshire, United States, 03756

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Bridgewater, New Jersey, United States, 08807

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Somerset, New Jersey, United States, 08873

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Brooklyn, New York, United States, 11201

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Buffalo, New York, United States, 14217

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Laurelton, New York, United States, 11413

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New York, New York, United States, 10029

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Saratoga Springs, New York, United States, 12866

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The Bronx, New York, United States, 10451

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Asheville, North Carolina, United States, 28803

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Chapel Hill, North Carolina, United States, 27599

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Durham, North Carolina, United States, 27701

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Durham, North Carolina, United States, 27705

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Monroe, North Carolina, United States, 28112

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Morehead City, North Carolina, United States, 28557

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Morganton, North Carolina, United States, 28655

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New Bern, North Carolina, United States, 28562

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Wilmington, North Carolina, United States, 28401

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Winston-Salem, North Carolina, United States, 27157

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Fargo, North Dakota, United States, 58104

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Cincinnati, Ohio, United States, 45220

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Columbus, Ohio, United States, 43213

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Lima, Ohio, United States, 45801

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Maumee, Ohio, United States, 43537

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Oklahoma City, Oklahoma, United States, 73134

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Camp Hill, Pennsylvania, United States, 17011

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Horsham, Pennsylvania, United States, 19044

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Philadelphia, Pennsylvania, United States, 19114

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Smithfield, Pennsylvania, United States, 15478

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West Chester, Pennsylvania, United States, 19380

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Yardley, Pennsylvania, United States, 19067

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Providence, Rhode Island, United States, 02908

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Charleston, South Carolina, United States, 29402

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Fort Mill, South Carolina, United States, 29707

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Mauldin, South Carolina, United States, 29662

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North Charleston, South Carolina, United States, 29405

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Rapid City, South Dakota, United States, 57701

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Chattanooga, Tennessee, United States, 37404

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Chattanooga, Tennessee, United States, 37421

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Knoxville, Tennessee, United States, 37909

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Knoxville, Tennessee, United States, 37912

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Knoxville, Tennessee, United States, 37938

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Memphis, Tennessee, United States, 38119

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Memphis, Tennessee, United States, 38128

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Morristown, Tennessee, United States, 37813

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Tullahoma, Tennessee, United States, 37388

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Amarillo, Texas, United States, 79106

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Beaumont, Texas, United States, 77706

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Brownsville, Texas, United States, 78526

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Corpus Christi, Texas, United States, 78404

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Dallas, Texas, United States, 75216

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Dallas, Texas, United States, 75234

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Dallas, Texas, United States, 75246

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DeSoto, Texas, United States, 75115

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El Paso, Texas, United States, 79905

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Euless, Texas, United States, 76040

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Houston, Texas, United States, 77002

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Houston, Texas, United States, 77025

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Houston, Texas, United States, 77034

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Houston, Texas, United States, 77043

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Houston, Texas, United States, 77087

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Humble, Texas, United States, 77338

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Irving, Texas, United States, 75061

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Kingwood, Texas, United States, 77339

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Kingwood, Texas, United States, 77345

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McAllen, Texas, United States, 78503

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McKinney, Texas, United States, 75069

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Mesquite, Texas, United States, 75149

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Odessa, Texas, United States, 79761

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Paris, Texas, United States, 75462

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Pharr, Texas, United States, 78577

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Plano, Texas, United States, 75093

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San Antonio, Texas, United States, 78207

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San Antonio, Texas, United States, 78212

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Sugar Land, Texas, United States, 77478

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Sugar Land, Texas, United States, 77479

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Temple, Texas, United States, 76508

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Tomball, Texas, United States, 77375

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Tyler, Texas, United States, 75701

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Victoria, Texas, United States, 77901

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Bountiful, Utah, United States, 84010

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Ogden, Utah, United States, 84405

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White River Junction, Vermont, United States, 05001

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Fairfax, Virginia, United States, 22031

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Falls Church, Virginia, United States, 22042

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Hopewell, Virginia, United States, 23860

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Manassas, Virginia, United States, 20109

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Manassas, Virginia, United States, 20110

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Newport News, Virginia, United States, 23606

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Norfolk, Virginia, United States, 23504

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Richmond, Virginia, United States, 23219

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Redmond, Washington, United States, 98052

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Renton, Washington, United States, 98057

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Seattle, Washington, United States, 98122

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Tacoma, Washington, United States, 98405

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Morgantown, West Virginia, United States, 26505

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Red Deer, Alberta, Canada, T4P 1K4

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Richmond, British Columbia, Canada, V6V 2L1

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Vancouver, British Columbia, Canada, V6Z2H2

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Victoria, British Columbia, Canada, V8T 5G4

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Bridgewater, Nova Scotia, Canada, B4V 3N2

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Halifax, Nova Scotia, Canada, B3H 1V8

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Sydney, Nova Scotia, Canada, B1M 0A1

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Brampton, Ontario, Canada, L6S 0C6

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Cambridge, Ontario, Canada, N1R 6V6

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Etobicoke, Ontario, Canada, M8Z 4E4

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Hamilton, Ontario, Canada, L8L 5G4

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Kingston, Ontario, Canada, K7M 7E4

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Markham, Ontario, Canada, L3S 0A2

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Mississauga, Ontario, Canada, L5K2L3

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Newmarket, Ontario, Canada, L3Y 2P6

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North York, Ontario, Canada, M6B 3H7

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North York, Ontario, Canada, M9N 1W4

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Scarborough Village, Ontario, Canada, M1R 0B1

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Stoney Creek, Ontario, Canada, L8J 3W2

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Thunder Bay, Ontario, Canada, P7B 7C7

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Toronto, Ontario, Canada, M6G 1M2

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Montreal, Quebec, Canada, H3G 1A4

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Québec, Quebec, Canada, G1G 5X1

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Québec, Quebec, Canada, G1V 4G5

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Québec, Quebec, Canada, G1V 4T3

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Québec, Quebec, Canada, G3K 2P8

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Sherbrooke, Quebec, Canada, J1L 0K3

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Terrebonne, Quebec, Canada, J6V 2H2

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Trois-Rivières, Quebec, Canada, G9A 4P3

More Information

Sponsor

AstraZeneca

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Atherosclerotic Cardiovascular Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-24.