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Status:

RECRUITING

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

Lead Sponsor:

AstraZeneca

Conditions:

Cardiovascular Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 re...

Detailed Description

This is a randomised, double-blind, placebo-controlled, parallel-group Phase III study to evaluate the effect on the reduction of LDL-C and the safety and tolerability of AZD0780 versus placebo, admin...

Eligibility Criteria

Inclusion

  • 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:
  • Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 28 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 24 2027

    Estimated Enrollment :

    2800 Patients enrolled

    Trial Details

    Trial ID

    NCT07000123

    Start Date

    May 28 2025

    End Date

    March 24 2027

    Last Update

    November 26 2025

    Active Locations (496)

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    Page 1 of 124 (496 locations)

    1

    Research Site

    Huntsville, Alabama, United States, 35801

    2

    Research Site

    Irondale, Alabama, United States, 35210

    3

    Research Site

    Mobile, Alabama, United States, 36608

    4

    Research Site

    Gilbert, Arizona, United States, 85296