Cardiovascular DiseasePhase 3AZURE-LDLNCT07000123

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

A Phase 3 study testing AZD0780 in people with Cardiovascular Disease, run by AstraZeneca at 404 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiovascular Disease
What is being tested?: AZD0780
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,103 participants
Where: 404 sitesin 22 countries
Study dates: 28 May 2025to 11 Jan 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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).

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Thus, the background lipid-lowering therapy must consist of one of the following:
A high intensity LDL lowering regimen
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.

Who cannot join

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)

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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.

Trial locations and contacts

404 sites in 22 countries.

Country

City, postcode or hospital

404 sites in 22 countries

United States101 sites

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

Other trials in United States

Germany43 sites

Research Site
Amberg, 92224
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Bad Homburg, 61348
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Berlin, 10117
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Berlin, 10629
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Berlin, 10787
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Berlin, 12203
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Berlin, 13347
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Dresden, 01069
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Dresden, 01099
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Dresden, 01307
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Essen, 45355
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Essen, 45359
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Falkensee, 14612
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Frankfurt, 60596
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Freiburg im Breisgau, 79106
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Greifswald, 17475
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Hamburg, 20095
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Hamburg, 20253
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Hamburg, 22415
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Hamburg, 22607
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Hanover, 30159
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Heidelberg, 69120
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Hohenmölsen, 06679
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Kaiserslautern, 67655
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Karlsruhe, 76137
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Kiel, 24105
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Leipzig, 04103
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Leipzig, 04177
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Magdeburg, 39120
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Mannheim, 68165
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Markkleeberg, 04416
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München, 80636
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Munich, 80809
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Münster, 48145
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Münster, 48149
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Nuremberg, 90402
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Offenbach, 63065
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Potsdam, 14471
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Schwerin, 19055
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Stuhr, 28816
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Stuttgart, 70376
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Wermsdorf, 04779
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Witten, 58455

Other trials in Germany

Japan24 sites

Research Site
Ami-machi, 300-1155
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Asahi-shi, 289-2511
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Chūōku, 103-0027
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Hamamatsu, 432-8580
Research Site
Ichikawa-shi, 272-8516
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Kanazawa, 920-8530
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Kanazawa, 920-8650
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Kasuya-gun, 811-2310
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Kishiwada-shi, 596-8522
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Kitakyushu, 802-8555
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Komatsu-shi, 923-8560
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Kure-shi, 737-0023
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Minatoku, 108-0014
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Minatoku, 108-0073
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Nagoya, 457-8511
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Okayama, 700-0804
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Osaka, 543-8922
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Suwa-shi, 392-8510
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Tamanashi, 865-0016
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Tsukuba, 305-8558
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Urasoe-Shi, 901-2102
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Ushiku-shi, 300-1207
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Utsunomiya, 320-8580
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Yokohama, 245-8575

Other trials in Japan

Poland23 sites

Research Site
Bialystok, 15-481
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Gdansk, 80-214
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Gdynia, 81-384
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Katowice, 40-600
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Kędzierzyn-Koźle, 47-200
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Krakow, 31-121
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Krakow, 31-322
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Lodz, 90-127
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Lodz, 91-363
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Lublin, 20-011
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Lublin, 20-068
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Lublin, 20-718
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Płock, 09-407
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Poznan, 60-266
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Poznan, 60-702
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Poznan, 61-848
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Rzeszów, 35-205
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Szczecin, 71-526
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Warsaw, 00-124
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Warsaw, 00-710
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Warsaw, 02-758
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Wroclaw, 50-381
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Zabrze, 41-800

Other trials in Poland

Hungary22 sites

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Balatonfüred, 8230
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Békéscsaba, 5600
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Budapest, 1027
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Budapest, 1033
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Budapest, 1036
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Budapest, 1102
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Budapest, 1122
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Budapest, 1132
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Budapest, 1141
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Budapest, 1148
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Debrecen, 4032
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Dunaújváros, 2400
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Kalocsa, 6300
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Kaposvár, 7400
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Nyíregyháza, 4400
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Nyíregyháza-Sóstóhegy, 4481
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Orosháza, 5900
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Pécs, 7623
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Pécs, 7624
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Szeged, 6725
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Székesfehérvár, 8000
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Zalaegerszeg, 8900

Other trials in Hungary

South Korea22 sites

Research Site
Anyang-si, 14068
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Bucheon-si, 14754
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Busan, 47392
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Busan, 48108
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Changwon-si, 51353
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Cheonan-si, 31151
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Daegu, 42601
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Daejeon, 35015
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Gangwon-do, 26426
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Goyang-si, 10380
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Gwangju, 61469
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Jeju City, 690-767
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Jeonju, 54907
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Jinju, 660-702
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Seongnam-si, 13620
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Seoul, 01830
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Seoul, 03080
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Seoul, 03181
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Seoul, 07804
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Seoul, 120-752
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Seoul, 135-710
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Seoul, 5505

Other trials in South Korea

Canada21 sites

Research Site
Cambridge, Ontario, N1R 6V6
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Chicoutimi, Quebec, G7H 7K9
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Courtice, Ontario, L1E 2J5
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Guelph, Ontario, N1H 1B1
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Hamilton, Ontario, L8J 0B6
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Hamilton, Ontario, L8L 5G4
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Joliette, Quebec, J6E 6A9
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Mississauga, Ontario, L5K2L3
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Montreal, Quebec, H4N 2W2
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North York, Ontario, M6B 3H7
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North York, Ontario, M9N 1W4
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Québec, Quebec, G1V 4W2
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Sarnia, Ontario, N7T 4X3
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Sherbrooke, Quebec, J1L 0K3
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Stoney Creek, Ontario, L8J 3W2
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Stouffville, Ontario, L4A1H2
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Surrey, British Columbia, V3T 4G8
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Toronto, Ontario, M3J 0K2
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Toronto, Ontario, M6G 1M2
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Toronto, Ontario, M9V 4B4
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Vancouver, British Columbia, V6Z2H2

Other trials in Canada

Czechia15 sites

Research Site
Benešov, 256 01
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Brandýs nad Labem, 250 01
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České Budějovice, 370 11
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Chlumec nad Cidlinou, 503 51
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Hodonín, 695 01
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Jílové u Prahy, 254 01
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Klatovy, 339 01
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Prague, 104 00
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Prague, 143 00
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Prague, 149 00
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Praha Uhříněves, 104 00
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Příbram, 261 01
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Teplice, 415 01
Research Site
Trutnov, 54101
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Uherské Hradiště, 686 01

Other trials in Czechia

Ukraine15 sites

Research Site
Chernivtsi, 58022
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Ivano-Frankivsk, 76018
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Kyiv, 02081
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Kyiv, 02166
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Kyiv, 03037
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Kyiv, 03049
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Kyiv, 03151
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Kyiv, 03680
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Kyiv, 04050
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Kyiv, 04114
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Kyiv, 04210
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Lutsk, 430024
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Vinnytsia, 21001
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Vinnytsia, 21009
Research Site
Vinnytsia, 21029

Other trials in Ukraine

United Kingdom15 sites

Research Site
Chesterfield, S40 4AA
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Chippenham, SN15 2SB
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Corby, NN18 9EZ
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Coventry, CV3 4FJ
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Harrow, HA3 7LT
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Hull, HU7 4DW
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London, W6 7HY
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Northwood, HA6 2RN
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Orpington, BR5 3QG
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Poole, BH14 8EE
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Rotherham, S65 1DA
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Shipley, BD18 3SA
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Thetford, IP24 1JD
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Trowbridge, BA14 8LW
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Weston-super-Mare, BS24 7PR

Other trials in United Kingdom

Argentina14 sites

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CABA, C1425HFA
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CABA, C1426
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Ciudad Autonoma de Bs As, C1023AAB
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Ciudad de Buenos Aires, C1006ACC
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Ciudad de Buenos Aires, C1094AAD
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Córdoba, X5003DCE
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Córdoba, X5003DCP
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Godoy Cruz, M5501ARP
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Mar del Plata, B7600
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Rosario, 2000
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Rosario, S2000PBJ
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San Nicolás, B2900DMH
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San Vicente, 5006
Research Site
Zárate, 2800

Other trials in Argentina

Slovakia11 sites

Research Site
Bratislava, 831 03
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Bratislava, 83106
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Košice, 04022
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Levice, 93401
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Lučenec, 984 01
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Malacky, 90101
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Námestovo, 02901
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Prešov, 080 01
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Rožňava, 048 01
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Svidník, 08901
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Vinica, 991 28

Other trials in Slovakia

Chile10 sites

Research Site
Independencia, 8380465
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Santiago, 7500587
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Santiago, 7500710
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Santiago, 7770086
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Santiago, 8330034
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Santiago, 8331143
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Santiago, 8380456
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Santiago, 8910259
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Valdivia, 5090000
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Victoria, 4720000

Other trials in Chile

Spain10 sites

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A Coruña, 15006
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Barcelona, 08025
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Barcelona, 08041
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Córdoba, 14004
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Córdoba, 14011
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Madrid, 28041
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Santiago(A Coruña), 15706
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Seville, 41004
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Seville, 41013
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Seville, 41071

Other trials in Spain

Bulgaria9 sites

Research Site
Dupnitsa, 2600
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Dupnitsa, 2602
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Haskovo, 6304
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Plovdiv, 4000
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Plovdiv, 4002
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Sliven, 8800
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Sofia, 1431
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Sofia, 1618
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Varna, 9000

Other trials in Bulgaria

Australia8 sites

Research Site
Coffs Harbour, 02450
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Ipswich, 4305
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Joondalup, 6027
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Leabrook, 5068
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Liverpool, 2170
Research Site
Maroubra, 2035
Research Site
Melbourne, 3004
Research Site
Woolloongabba, 4102

Other trials in Australia

Brazil8 sites

Research Site
Brasília, 71625-009
Research Site
Campina Grande do Sul, 83.430-000
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Campinas, 13060-080
Research Site
Goiânia, 74605-020
Research Site
Porto Alegre, 90630-165
Research Site
Rio de Janeiro, 20241-180
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São Paulo, 04012-180
Research Site
São Paulo, 05403-000

Other trials in Brazil

Taiwan8 sites

Research Site
Kaohsiung City, 807
Research Site
Kaohsiung City, 824
Research Site
Taichung, 40705
Research Site
Taichung, 433004
Research Site
Tainan, 710027
Research Site
Taipei, 100
Research Site
Taipei, 110
Research Site
Taipei, 11217

Other trials in Taiwan

Turkey (Türkiye)8 sites

Research Site
Adana, 01060
Research Site
Afyonkarahisar, 03030
Research Site
Ankara, 06530
Research Site
Eskişehir, 26040
Research Site
Izmir, 35100
Research Site
Kocaeli, 41001
Research Site
Odunpazari, 26080
Research Site
Yenimahalle, 06170

Other trials in Turkey (Türkiye)

Malaysia7 sites

Research Site
Bandar Aman Jaya, 08000
Research Site
Ipoh, 30990
Research Site
Kuching, 93586
Research Site
Sarawak Miri, 98000
Research Site
Seri Manjung, 32040
Research Site
Sibu, 96000
Research Site
Sungai Buloh, 47000

Other trials in Malaysia

India5 sites

Research Site
Belagavi, 590010
Research Site
Dehradun, 248001
Research Site
Kanpur, 208001
Research Site
Kochi, 682018
Research Site
New Delhi, 110017

Other trials in India

Vietnam5 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000
Research Site
Hochiminh, 70000
Research Site
Huế, 530000

Other trials in Vietnam

About this study

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

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.

Read the 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, administered as xx mg once daily orally, on top of a high intensity lipid-lowering regimen. The target population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical ASCVD or ≥ 70 mg/dL and at risk for a first ASCVD event.

The study will be conducted at approximately 470 centres in approximately 21 countries.

The screening period is up to 14 days (and may be conditionally extended), starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 52 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 xx mg orally once daily during the treatment period, while those in the placebo group will receive matching placebo. The study will include approximately 2800 randomised participants. An independent data monitoring committee will, on a regular basis, review accumulating data from the study, evaluate adverse effects of the IMP, and make recommendations regarding whether to halt or modify the study.

Conditions: Cardiovascular Disease
Being tested: AZD0780, Placebo
Keywords: Low-Density Lipoprotein Cholesterol, Atherosclerotic Cardiovascular Disease
Medical subject headings: Cardiovascular Diseases, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD0780Drug
Participants will receive daily oral dose of AZD0780
PlaceboDrug
Participants will receive daily oral dose of placebo

Study groups in NCT07000123
Study group	Role	What they receive
AZD0780	Experimental	Participants will receive daily oral dose of AZD0780 Receives: Drug: AZD0780
Placebo	Placebo comparator	Participants will receive daily oral dose of placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative change in LDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
Measured: Baseline - 12 weeks

Secondary outcomes (9)

Relative change in LDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in patients on background statin therapy
Measured: Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 70 mg/dL at 12 weeks in patients with baseline LDL-C ≥ 70 mg/dL
Measured: Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 55 mg/dL at 12 weeks
Measured: Baseline - 12 weeks
Relative change in LDL-C from baseline to 28 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 28 weeks
Measured: Baseline - 28 weeks
Relative change in LDL-C from baseline to 52 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 52 weeks
Measured: Baseline - 52 weeks
Relative change in Apo B from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on apolipoprotein (Apo) B at 12 weeks
Measured: Baseline - 12 weeks
Relative change in non-HDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on non-high-density lipoprotein cholesterol (HDL-C) at 12 weeks
Measured: Baseline - 12 weeks
Relative change in total cholesterol from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on total cholesterol at 12 weeks
Measured: Baseline - 12 weeks
Relative change in Lp(a) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on lipoprotein(a) (Lp[a]) at 12 weeks
Measured: Baseline - 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 202511 Jan 2027

First posted2 Jun 2025
Study start28 May 2025
Primary completion11 Jan 2027 (estimated)
Study completion11 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 3,103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07000123
Sponsor's protocol ID: D7960C00012
Other IDs: 2025-520521-21, 2025
Acronym: AZURE-LDL
Status last verified: Aug 2026
First submitted: 23 May 2025
Last updated: 11 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cardiovascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07000123
Acronym / sponsor ID: AZURE-LDL / D7960C00012
Conditions: Cardiovascular Disease
Keywords: Low-Density Lipoprotein Cholesterol, Atherosclerotic Cardiovascular Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 3,103 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 28 May 2025 (actual)
Primary completion: 11 Jan 2027 (estimated)
Study completion: 11 Jan 2027 (estimated)
First posted: 2 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will be conducted at approximately 470 centres in approximately 21 countries.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group

Arm	Type	Receives
AZD0780	Experimental	Drug: AZD0780Participants will receive daily oral dose of AZD0780
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive daily oral dose of placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

≥ 18 years of age at the time of signing the ICF
History of clinical ASCVD or at risk for a first ASCVD event:
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).
A high intensity LDL lowering regimen

Key exclusion criteria (13 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD0780Participants will receive daily oral dose of AZD0780	Drug	AZD0780
PlaceboParticipants will receive daily oral dose of placebo	Drug	Placebo

Primary outcome

Relative change in LDL-C from baseline to 12 weeks
Time frame: Baseline - 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks

9 secondary outcomes

Relative change in LDL-C from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
Time frame: Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in LDL-C from baseline to 28 weeks
Time frame: Baseline - 28 weeks
Relative change in LDL-C from baseline to 52 weeks
Time frame: Baseline - 52 weeks
Relative change in Apo B from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in non-HDL-C from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in total cholesterol from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in Lp(a) from baseline to 12 weeks
Time frame: Baseline - 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

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Relapsed or Refractory Multiple Myeloma (RRMM)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

404 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0780 in people with Cardiovascular Disease, run by AstraZeneca at 404 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 404 sites in United States, Germany, Japan, Poland, Hungary and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in LDL-C from baseline to 12 weeks (time frame: Baseline - 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07000123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.