ACTIVE_NOT_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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-28
Study Completion:2027-01-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07000123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age at the time of signing the ICF
  2. * History of clinical ASCVD or at risk for a first ASCVD event:
  3. 1. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
  4. 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.
  5. * 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
  6. * 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).
  1. * 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.
  2. * Any of the following laboratory values at screening:
  3. * Calculated eGFR \< 15 mL/min/1.73 m2
  4. * AST or ALT \> 3 × ULN
  5. * TBL \> 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin \< 1.5 × ULN)
  6. * Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)
  7. * Creatine kinase \> 5 × ULN
  8. * Urine albumin-to-creatinine ratio ≥ 500 mg/g
  9. * Uncontrolled type 2 diabetes mellitus defined as HbA1C ≥ 9.5% at screening
  10. * 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
  11. * Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study.
  12. * Use of gemfibrozil within 1 week prior to screening or planned use during the study.
  13. * 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.

Contacts and Locations

Study Locations (Sites)

Research Site
Huntsville, Alabama, 35801
United States
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Irondale, Alabama, 35210
United States
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Mobile, Alabama, 36608
United States
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Gilbert, Arizona, 85296
United States
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Phoenix, Arizona, 85014
United States
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Sun City West, Arizona, 85375
United States
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Garden Grove, California, 92844
United States
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Gardena, California, 90247
United States
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Lancaster, California, 93534
United States
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Lincoln, California, 95648
United States
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San Diego, California, 92103
United States
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San Diego, California, 92111
United States
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Torrance, California, 90502
United States
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West Hills, California, 91307
United States
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Hamden, Connecticut, 06517
United States
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Boca Raton, Florida, 33434
United States
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Hallandale, Florida, 33009
United States
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Hialeah, Florida, 33012
United States
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Inverness, Florida, 34452
United States
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Jacksonville, Florida, 32216
United States
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Miami, Florida, 33176
United States
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New Port Richey, Florida, 34653
United States
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Orlando, Florida, 32807
United States
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Pembroke Pines, Florida, 33029
United States
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Seminole, Florida, 33777
United States
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Tampa, Florida, 33625
United States
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Atlanta, Georgia, 30328
United States
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Atlanta, Georgia, 30342
United States
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Decatur, Georgia, 30030
United States
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Peachtree Corners, Georgia, 30092
United States
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Chicago, Illinois, 60607
United States
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Winfield, Illinois, 60190
United States
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Evansville, Indiana, 47714
United States
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Evansville, Indiana, 47715
United States
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Indianapolis, Indiana, 46260
United States
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Ames, Iowa, 50010
United States
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El Dorado, Kansas, 67042
United States
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Wichita, Kansas, 67218
United States
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Owensboro, Kentucky, 42301
United States
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Hammond, Louisiana, 70403
United States
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Kenner, Louisiana, 70065
United States
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Lafayette, Louisiana, 70508
United States
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Lake Charles, Louisiana, 70601
United States
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Shreveport, Louisiana, 71105
United States
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Zachary, Louisiana, 70791
United States
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Annapolis, Maryland, 21401
United States
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Baltimore, Maryland, 21229
United States
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Beltsville, Maryland, 20705
United States
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Potomac, Maryland, 20854
United States
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Chesterfield, Missouri, 63005
United States
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Jefferson City, Missouri, 65109
United States
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Kansas City, Missouri, 64131
United States
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Missoula, Montana, 59808
United States
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Buffalo, New York, 14217
United States
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Rochester, New York, 14609
United States
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The Bronx, New York, 10451
United States
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Durham, North Carolina, 27701
United States
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Greensboro, North Carolina, 27408
United States
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Hickory, North Carolina, 28601
United States
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Morganton, North Carolina, 28655
United States
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New Bern, North Carolina, 28562
United States
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Raleigh, North Carolina, 27609
United States
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Rocky Mount, North Carolina, 27804
United States
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Salisbury, North Carolina, 28144
United States
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Statesville, North Carolina, 28625
United States
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Wilmington, North Carolina, 28401
United States
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Fargo, North Dakota, 58104
United States
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Blue Ash, Ohio, 45242
United States
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Columbus, Ohio, 43213
United States
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Columbus, Ohio, 43215
United States
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Lima, Ohio, 45805
United States
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Camp Hill, Pennsylvania, 17011
United States
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Horsham, Pennsylvania, 19044
United States
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Philadelphia, Pennsylvania, 19114
United States
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West Chester, Pennsylvania, 19380
United States
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Anderson, South Carolina, 29621
United States
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Fort Mill, South Carolina, 29707
United States
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Mauldin, South Carolina, 29662
United States
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Mt. Pleasant, South Carolina, 29464
United States
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North Charleston, South Carolina, 29405
United States
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Rapid City, South Dakota, 57701
United States
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Bristol, Tennessee, 37620
United States
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Knoxville, Tennessee, 37849
United States
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Knoxville, Tennessee, 37912
United States
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Knoxville, Tennessee, 37938
United States
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Beaumont, Texas, 77706
United States
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El Paso, Texas, 79902
United States
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Houston, Texas, 77043
United States
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Humble, Texas, 77338
United States
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Irving, Texas, 75061
United States
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Katy, Texas, 77450
United States
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Mesquite, Texas, 75149
United States
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Paris, Texas, 75462
United States
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San Antonio, Texas, 78229
United States
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San Marcos, Texas, 78666
United States
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Sugar Land, Texas, 77478
United States
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Charlottesville, Virginia, 22911
United States
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Hampton, Virginia, 23666
United States
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Norfolk, Virginia, 23504
United States
Research Site
Suffolk, Virginia, 23435
United States
Research Site
Redmond, Washington, 98052
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-28
Study Completion Date2027-01-11

Study Record Updates

Study Start Date2025-05-28
Study Completion Date2027-01-11

Terms related to this study

Keywords Provided by Researchers

  • Low-Density Lipoprotein Cholesterol
  • Atherosclerotic Cardiovascular Disease

Additional Relevant MeSH Terms

  • Cardiovascular Disease