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NCT07000123

PHASE3

A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.

Official title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Elevated Low Density Lipoprotein Cholesterol and Clinical Atherosclerotic Cardiovascular Disease or at Risk for a First Atherosclerotic Cardiovascular Disease Event

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3103

Start Date

2025-05-28

Completion Date

2027-01-11

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Cardiovascular Disease

Interventions

DRUG

AZD0780

Participants will receive daily oral dose of AZD0780

DRUG

Placebo

Participants will receive daily oral dose of placebo

Inclusion Criteria: * ≥ 18 years of age at the time of signing the ICF * History of clinical ASCVD or at risk for a first ASCVD event: 1. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease. 2. A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds \[coronary, carotid, lower extremity\], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or other relevant national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD. * Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event * 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). Thus, the background lipid-lowering therapy must consist of one of the following: \- A high intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid : OR: \- A maximum tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended. Participants must achieve a stable background lipid lowering therapy \> 28 days before screening. Exclusion criteria: * Homozygous familial hypercholesterolaemia, known diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator. * Any of the following laboratory values at screening: * Calculated eGFR \< 15 mL/min/1.73 m2 * AST or ALT \> 3 × ULN * TBL \> 2 × ULN (except for patients with Gilberts 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-to-creatinine ratio ≥ 500 mg/g * Uncontrolled type 2 diabetes mellitus 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 prior to screening or planned use during the study. * Use of gemfibrozil within 1 week prior to screening or planned use during the study. * Use of PCSK-9 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. Any other approved PCSK-9 inhibitor use within 5 half-lives prior to the screening visit or planned use during the study.

Locations (404)

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Huntsville, Alabama, United States

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Irondale, Alabama, United States

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Mobile, Alabama, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Sun City West, Arizona, United States

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Garden Grove, California, United States

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Hamden, Connecticut, United States

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Hialeah, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Winfield, Illinois, United States

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Evansville, Indiana, United States

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Ames, Iowa, United States

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El Dorado, Kansas, United States

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Wichita, Kansas, United States

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Owensboro, Kentucky, United States

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Hammond, Louisiana, United States

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Kenner, Louisiana, United States

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Lafayette, Louisiana, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Zachary, Louisiana, United States

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Annapolis, Maryland, United States

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Potomac, Maryland, United States

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Chesterfield, Missouri, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Morganton, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Fargo, North Dakota, United States

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Blue Ash, Ohio, United States

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Lima, Ohio, United States

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Camp Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Anderson, South Carolina, United States

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Fort Mill, South Carolina, United States

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Mauldin, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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North Charleston, South Carolina, United States

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Bristol, Tennessee, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Beaumont, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Humble, Texas, United States

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Irving, Texas, United States

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Katy, Texas, United States

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Mesquite, Texas, United States

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Paris, Texas, United States

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San Antonio, Texas, United States

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San Marcos, Texas, United States

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Sugar Land, Texas, United States

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Charlottesville, Virginia, United States

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Hampton, Virginia, United States

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Norfolk, Virginia, United States

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Suffolk, Virginia, United States

And 304 more locations on ClinicalTrials.gov

Clinical Research Directory

A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (404)