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
AZURE-LDL
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
2 other identifiers
interventional
3,046
22 countries
404
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2025
404 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedStudy Start
First participant enrolled
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 11, 2027
January 20, 2026
January 1, 2026
1.6 years
May 23, 2025
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline - 12 weeks
Secondary Outcomes (9)
Relative change in LDL-C from baseline to 12 weeks
Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
Baseline - 12 weeks
Relative change in LDL-C from baseline to 28 weeks
Baseline - 28 weeks
Relative change in LDL-C from baseline to 52 weeks
Baseline - 52 weeks
- +4 more secondary outcomes
Study Arms (2)
AZD0780
EXPERIMENTALParticipants will receive daily oral dose of AZD0780
Placebo
PLACEBO COMPARATORParticipants will receive daily oral dose of placebo
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (404)
Research Site
Huntsville, Alabama, 35801, United States
Research Site
Irondale, Alabama, 35210, United States
Research Site
Mobile, Alabama, 36608, United States
Research Site
Gilbert, Arizona, 85296, United States
Research Site
Phoenix, Arizona, 85014, United States
Research Site
Sun City West, Arizona, 85375, United States
Research Site
Garden Grove, California, 92844, United States
Research Site
Gardena, California, 90247, United States
Research Site
Lancaster, California, 93534, United States
Research Site
Lincoln, California, 95648, United States
Research Site
San Diego, California, 92103, United States
Research Site
San Diego, California, 92111, United States
Research Site
Torrance, California, 90502, United States
Research Site
West Hills, California, 91307, United States
Research Site
Hamden, Connecticut, 06517, United States
Research Site
Boca Raton, Florida, 33434, United States
Research Site
Hallandale, Florida, 33009, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Inverness, Florida, 34452, United States
Research Site
Jacksonville, Florida, 32216, United States
Research Site
Miami, Florida, 33176, United States
Research Site
New Port Richey, Florida, 34653, United States
Research Site
Orlando, Florida, 32807, United States
Research Site
Pembroke Pines, Florida, 33029, United States
Research Site
Seminole, Florida, 33777, United States
Research Site
Tampa, Florida, 33625, United States
Research Site
Atlanta, Georgia, 30328, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Decatur, Georgia, 30030, United States
Research Site
Peachtree Corners, Georgia, 30092, United States
Research Site
Chicago, Illinois, 60607, United States
Research Site
Winfield, Illinois, 60190, United States
Research Site
Evansville, Indiana, 47714, United States
Research Site
Evansville, Indiana, 47715, United States
Research Site
Indianapolis, Indiana, 46260, United States
Research Site
Ames, Iowa, 50010, United States
Research Site
El Dorado, Kansas, 67042, United States
Research Site
Wichita, Kansas, 67218, United States
Research Site
Owensboro, Kentucky, 42301, United States
Research Site
Hammond, Louisiana, 70403, United States
Research Site
Kenner, Louisiana, 70065, United States
Research Site
Lafayette, Louisiana, 70508, United States
Research Site
Lake Charles, Louisiana, 70601, United States
Research Site
Shreveport, Louisiana, 71105, United States
Research Site
Zachary, Louisiana, 70791, United States
Research Site
Annapolis, Maryland, 21401, United States
Research Site
Baltimore, Maryland, 21229, United States
Research Site
Beltsville, Maryland, 20705, United States
Research Site
Potomac, Maryland, 20854, United States
Research Site
Chesterfield, Missouri, 63005, United States
Research Site
Jefferson City, Missouri, 65109, United States
Research Site
Kansas City, Missouri, 64131, United States
Research Site
Missoula, Montana, 59808, United States
Research Site
Buffalo, New York, 14217, United States
Research Site
Rochester, New York, 14609, United States
Research Site
The Bronx, New York, 10451, United States
Research Site
Durham, North Carolina, 27701, United States
Research Site
Greensboro, North Carolina, 27408, United States
Research Site
Hickory, North Carolina, 28601, United States
Research Site
Morganton, North Carolina, 28655, United States
Research Site
New Bern, North Carolina, 28562, United States
Research Site
Raleigh, North Carolina, 27609, United States
Research Site
Rocky Mount, North Carolina, 27804, United States
Research Site
Salisbury, North Carolina, 28144, United States
Research Site
Statesville, North Carolina, 28625, United States
Research Site
Wilmington, North Carolina, 28401, United States
Research Site
Fargo, North Dakota, 58104, United States
Research Site
Blue Ash, Ohio, 45242, United States
Research Site
Columbus, Ohio, 43213, United States
Research Site
Columbus, Ohio, 43215, United States
Research Site
Lima, Ohio, 45805, United States
Research Site
Camp Hill, Pennsylvania, 17011, United States
Research Site
Horsham, Pennsylvania, 19044, United States
Research Site
Philadelphia, Pennsylvania, 19114, United States
Research Site
West Chester, Pennsylvania, 19380, United States
Research Site
Anderson, South Carolina, 29621, United States
Research Site
Fort Mill, South Carolina, 29707, United States
Research Site
Mauldin, South Carolina, 29662, United States
Research Site
Mt. Pleasant, South Carolina, 29464, United States
Research Site
North Charleston, South Carolina, 29405, United States
Research Site
Rapid City, South Dakota, 57701, United States
Research Site
Bristol, Tennessee, 37620, United States
Research Site
Knoxville, Tennessee, 37849, United States
Research Site
Knoxville, Tennessee, 37912, United States
Research Site
Knoxville, Tennessee, 37938, United States
Research Site
Beaumont, Texas, 77706, United States
Research Site
El Paso, Texas, 79902, United States
Research Site
Houston, Texas, 77043, United States
Research Site
Humble, Texas, 77338, United States
Research Site
Irving, Texas, 75061, United States
Research Site
Katy, Texas, 77450, United States
Research Site
Mesquite, Texas, 75149, United States
Research Site
Paris, Texas, 75462, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
San Marcos, Texas, 78666, United States
Research Site
Sugar Land, Texas, 77478, United States
Research Site
Charlottesville, Virginia, 22911, United States
Research Site
Hampton, Virginia, 23666, United States
Research Site
Norfolk, Virginia, 23504, United States
Research Site
Suffolk, Virginia, 23435, United States
Research Site
Redmond, Washington, 98052, United States
Research Site
CABA, C1425AGC, Argentina
Research Site
CABA, C1426, Argentina
Research Site
Ciudad Autonoma de Bs As, C1023AAB, Argentina
Research Site
Ciudad de Buenos Aires, C1006ACC, Argentina
Research Site
Ciudad de Buenos Aires, C1094AAD, Argentina
Research Site
Córdoba, X5003DCE, Argentina
Research Site
Córdoba, X5003DCP, Argentina
Research Site
Godoy Cruz, M5501ARP, Argentina
Research Site
Mar del Plata, B7600, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
Rosario, S2000PBJ, Argentina
Research Site
San Nicolás, B2900DMH, Argentina
Research Site
San Vicente, 5006, Argentina
Research Site
Zárate, 2800, Argentina
Research Site
Coffs Harbour, 02450, Australia
Research Site
Ipswich, 4305, Australia
Research Site
Joondalup, 6027, Australia
Research Site
Leabrook, 5068, Australia
Research Site
Liverpool, 2170, Australia
Research Site
Maroubra, 2035, Australia
Research Site
Melbourne, 3004, Australia
Research Site
Woolloongabba, 4102, Australia
Research Site
Brasília, 71625-009, Brazil
Research Site
Campina Grande do Sul, 83.430-000, Brazil
Research Site
Campinas, 13060-080, Brazil
Research Site
Goiânia, 74605-020, Brazil
Research Site
Porto Alegre, 90630-165, Brazil
Research Site
Rio de Janeiro, 20241-180, Brazil
Research Site
São Paulo, 04012-180, Brazil
Research Site
São Paulo, 05403-000, Brazil
Research Site
Dupnitsa, 2600, Bulgaria
Research Site
Dupnitsa, 2602, Bulgaria
Research Site
Haskovo, 6304, Bulgaria
Research Site
Plovdiv, 4000, Bulgaria
Research Site
Plovdiv, 4002, Bulgaria
Research Site
Sliven, 8800, Bulgaria
Research Site
Sofia, 1431, Bulgaria
Research Site
Sofia, 1618, Bulgaria
Research Site
Varna, 9000, Bulgaria
Research Site
Surrey, British Columbia, V3T 2V6, Canada
Research Site
Vancouver, British Columbia, V6Z2H2, Canada
Research Site
Cambridge, Ontario, N1R 6V6, Canada
Research Site
Courtice, Ontario, L1E 2J5, Canada
Research Site
Guelph, Ontario, N1H 1B1, Canada
Research Site
Hamilton, Ontario, L8J 0B6, Canada
Research Site
Hamilton, Ontario, L8L 5G4, Canada
Research Site
Mississauga, Ontario, L5K2L3, Canada
Research Site
North York, Ontario, M6B 3H7, Canada
Research Site
North York, Ontario, M9N 1W4, Canada
Research Site
Sarnia, Ontario, N7T 4X3, Canada
Research Site
Stoney Creek, Ontario, L8J 3W2, Canada
Research Site
Stouffville, Ontario, L4A1H2, Canada
Research Site
Toronto, Ontario, M3J 0K2, Canada
Research Site
Toronto, Ontario, M6G 1M2, Canada
Research Site
Toronto, Ontario, M9V 4B4, Canada
Research Site
Chicoutimi, Quebec, G7H 7K9, Canada
Research Site
Joliette, Quebec, J6E 6A9, Canada
Research Site
Montreal, Quebec, H4N 2W2, Canada
Research Site
Québec, Quebec, G1V 4W2, Canada
Research Site
Sherbrooke, Quebec, J1E 0N8, Canada
Research Site
Independencia, 8380465, Chile
Research Site
Santiago, 7500587, Chile
Research Site
Santiago, 7500710, Chile
Research Site
Santiago, 7770086, Chile
Research Site
Santiago, 8330034, Chile
Research Site
Santiago, 8331143, Chile
Research Site
Santiago, 8380456, Chile
Research Site
Santiago, 8910259, Chile
Research Site
Valdivia, 5090000, Chile
Research Site
Victoria, 4720000, Chile
Research Site
Benešov, 256 01, Czechia
Research Site
Brandýs nad Labem, 250 01, Czechia
Research Site
Chlumec nad Cidlinou, 503 51, Czechia
Research Site
České Budějovice, 370 11, Czechia
Research Site
Hodonín, 695 01, Czechia
Research Site
Jílové u Prahy, 254 01, Czechia
Research Site
Klatovy, 339 01, Czechia
Research Site
Prague, 104 00, Czechia
Research Site
Prague, 143 00, Czechia
Research Site
Prague, 149 00, Czechia
Research Site
Praha Uhříněves, 104 00, Czechia
Research Site
Příbram, 261 01, Czechia
Research Site
Teplice, 415 01, Czechia
Research Site
Trutnov, 54101, Czechia
Research Site
Uherské Hradiště, 686 01, Czechia
Research Site
Amberg, 92224, Germany
Research Site
Bad Homburg, 61348, Germany
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 10629, Germany
Research Site
Berlin, 10787, Germany
Research Site
Berlin, 12203, Germany
Research Site
Berlin, 13347, Germany
Research Site
Dresden, 01069, Germany
Research Site
Dresden, 01099, Germany
Research Site
Dresden, 01307, Germany
Research Site
Essen, 45355, Germany
Research Site
Essen, 45359, Germany
Research Site
Falkensee, 14612, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Freiburg im Breisgau, 79106, Germany
Research Site
Greifswald, 17475, Germany
Research Site
Hamburg, 20253, Germany
Research Site
Hamburg, 22143, Germany
Research Site
Hamburg, 22415, Germany
Research Site
Hamburg, 22607, Germany
Research Site
Hanover, 30159, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Hohenmölsen, 06679, Germany
Research Site
Kaiserslautern, 67655, Germany
Research Site
Karlsruhe, 76137, Germany
Research Site
Kiel, 24105, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Leipzig, 04177, Germany
Research Site
Magdeburg, 39120, Germany
Research Site
Mannheim, 68165, Germany
Research Site
Markkleeberg, 04416, Germany
Research Site
Munich, 80809, Germany
Research Site
München, 80636, Germany
Research Site
Münster, 48145, Germany
Research Site
Münster, 48149, Germany
Research Site
Nuremberg, 90402, Germany
Research Site
Offenbach, 63065, Germany
Research Site
Potsdam, 14471, Germany
Research Site
Schwerin, 19055, Germany
Research Site
Stuhr, 28816, Germany
Research Site
Stuttgart, 70376, Germany
Research Site
Wermsdorf, 04779, Germany
Research Site
Witten, 58455, Germany
Research Site
Balatonfüred, 8230, Hungary
Research Site
Békéscsaba, 5600, Hungary
Research Site
Budapest, 1027, Hungary
Research Site
Budapest, 1033, Hungary
Research Site
Budapest, 1036, Hungary
Research Site
Budapest, 1102, Hungary
Research Site
Budapest, 1122, Hungary
Research Site
Budapest, 1132, Hungary
Research Site
Budapest, 1141, Hungary
Research Site
Budapest, 1148, Hungary
Research Site
Debrecen, 4032, Hungary
Research Site
Dunaújváros, 2400, Hungary
Research Site
Kalocsa, 6300, Hungary
Research Site
Kaposvár, 7400, Hungary
Research Site
Nyíregyháza, 4400, Hungary
Research Site
Nyíregyháza-Sóstóhegy, 4481, Hungary
Research Site
Orosháza, 5900, Hungary
Research Site
Pécs, 7623, Hungary
Research Site
Pécs, 7624, Hungary
Research Site
Szeged, 6725, Hungary
Research Site
Székesfehérvár, 8000, Hungary
Research Site
Zalaegerszeg, 8900, Hungary
Research Site
Belagavi, 590010, India
Research Site
Dehradun, 248001, India
Research Site
Kanpur, 208001, India
Research Site
Kochi, 682018, India
Research Site
New Delhi, 110017, India
Research Site
Ami-machi, 300-1155, Japan
Research Site
Asahi-shi, 289-2511, Japan
Research Site
Chūōku, 103-0027, Japan
Research Site
Hamamatsu, 432-8580, Japan
Research Site
Ichikawa-shi, 272-8516, Japan
Research Site
Kanazawa, 920-8530, Japan
Research Site
Kanazawa, 920-8650, Japan
Research Site
Kasuya-gun, 811-2310, Japan
Research Site
Kishiwada-shi, 596-8522, Japan
Research Site
Kitakyushu, 802-8555, Japan
Research Site
Komatsu-shi, 923-8560, Japan
Research Site
Kure-shi, 737-0023, Japan
Research Site
Minatoku, 108-0014, Japan
Research Site
Minatoku, 108-0073, Japan
Research Site
Nagoya, 457-8511, Japan
Research Site
Okayama, 700-0804, Japan
Research Site
Osaka, 543-8922, Japan
Research Site
Suwa-shi, 392-8510, Japan
Research Site
Tamanashi, 865-0016, Japan
Research Site
Tsukuba, 305-8558, Japan
Research Site
Urasoe-Shi, 901-2102, Japan
Research Site
Ushiku-shi, 300-1207, Japan
Research Site
Utsunomiya, 320-8580, Japan
Research Site
Yokohama, 245-8575, Japan
Research Site
Bandar Aman Jaya, 08000, Malaysia
Research Site
Ipoh, 30990, Malaysia
Research Site
Kuching, 93586, Malaysia
Research Site
Sarawak Miri, 98000, Malaysia
Research Site
Seri Manjung, 32040, Malaysia
Research Site
Sibu, 96000, Malaysia
Research Site
Sungai Buloh, 47000, Malaysia
Research Site
Bialystok, 15-481, Poland
Research Site
Gdansk, 80-214, Poland
Research Site
Gdynia, 81-384, Poland
Research Site
Katowice, 40-600, Poland
Research Site
Kędzierzyn-Koźle, 47-200, Poland
Research Site
Krakow, 31-121, Poland
Research Site
Krakow, 31-322, Poland
Research Site
Lodz, 90-127, Poland
Research Site
Lodz, 91-363, Poland
Research Site
Lublin, 20-011, Poland
Research Site
Lublin, 20-068, Poland
Research Site
Lublin, 20-718, Poland
Research Site
Poznan, 60-266, Poland
Research Site
Poznan, 60-702, Poland
Research Site
Poznan, 61-848, Poland
Research Site
Płock, 09-407, Poland
Research Site
Rzeszów, 35-205, Poland
Research Site
Szczecin, 71-526, Poland
Research Site
Warsaw, 00-124, Poland
Research Site
Warsaw, 00-710, Poland
Research Site
Warsaw, 02-758, Poland
Research Site
Wroclaw, 50-381, Poland
Research Site
Zabrze, 41-800, Poland
Research Site
Bratislava, 831 03, Slovakia
Research Site
Bratislava, 83106, Slovakia
Research Site
Košice, 04022, Slovakia
Research Site
Levice, 93401, Slovakia
Research Site
Lučenec, 984 01, Slovakia
Research Site
Malacky, 90101, Slovakia
Research Site
Námestovo, 02901, Slovakia
Research Site
Prešov, 080 01, Slovakia
Research Site
Rožňava, 048 01, Slovakia
Research Site
Svidník, 08901, Slovakia
Research Site
Vinica, 991 28, Slovakia
Research Site
Anyang-si, 14068, South Korea
Research Site
Bucheon-si, 14754, South Korea
Research Site
Busan, 47392, South Korea
Research Site
Busan, 48108, South Korea
Research Site
Changwon-si, 51353, South Korea
Research Site
Cheonan-si, 31151, South Korea
Research Site
Daegu, 42601, South Korea
Research Site
Daejeon, 35015, South Korea
Research Site
Gangwon-do, 26426, South Korea
Research Site
Goyang-si, 10380, South Korea
Research Site
Gwangju, 61469, South Korea
Research Site
Jeju City, 690-767, South Korea
Research Site
Jeonju, 54907, South Korea
Research Site
Jinju, 660-702, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 01830, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03181, South Korea
Research Site
Seoul, 07804, South Korea
Research Site
Seoul, 120-752, South Korea
Research Site
Seoul, 135-710, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
A Coruña, 15006, Spain
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 08041, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Córdoba, 14011, Spain
Research Site
Madrid, 28041, Spain
Research Site
Santiago(A Coruña), 15706, Spain
Research Site
Seville, 41004, Spain
Research Site
Seville, 41013, Spain
Research Site
Seville, 41071, Spain
Research Site
Kaohsiung City, 807, Taiwan
Research Site
Kaohsiung City, 824, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taichung, 433004, Taiwan
Research Site
Tainan, 710027, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 110, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Adana, 01060, Turkey (Türkiye)
Research Site
Afyonkarahisar, 03030, Turkey (Türkiye)
Research Site
Ankara, 06530, Turkey (Türkiye)
Research Site
Eskişehir, 26040, Turkey (Türkiye)
Research Site
Izmir, 35100, Turkey (Türkiye)
Research Site
Kocaeli, 41001, Turkey (Türkiye)
Research Site
Odunpazari, 26080, Turkey (Türkiye)
Research Site
Yenimahalle, 06170, Turkey (Türkiye)
Research Site
Chernivtsi, 58022, Ukraine
Research Site
Ivano-Frankivsk, 76018, Ukraine
Research Site
Kyiv, 02081, Ukraine
Research Site
Kyiv, 02166, Ukraine
Research Site
Kyiv, 03037, Ukraine
Research Site
Kyiv, 03049, Ukraine
Research Site
Kyiv, 03151, Ukraine
Research Site
Kyiv, 03680, Ukraine
Research Site
Kyiv, 04050, Ukraine
Research Site
Kyiv, 04114, Ukraine
Research Site
Kyiv, 04210, Ukraine
Research Site
Lutsk, 430024, Ukraine
Research Site
Vinnytsia, 21001, Ukraine
Research Site
Vinnytsia, 21009, Ukraine
Research Site
Vinnytsia, 21029, Ukraine
Research Site
Chesterfield, S40 4AA, United Kingdom
Research Site
Chippenham, SN15 2SB, United Kingdom
Research Site
Corby, NN18 9EZ, United Kingdom
Research Site
Coventry, CV3 4FJ, United Kingdom
Research Site
Harrow, HA3 7LT, United Kingdom
Research Site
Hull, HU7 4DW, United Kingdom
Research Site
London, W6 7HY, United Kingdom
Research Site
Northwood, HA6 2RN, United Kingdom
Research Site
Orpington, BR5 3QG, United Kingdom
Research Site
Poole, BH14 8EE, United Kingdom
Research Site
Rotherham, S65 1DA, United Kingdom
Research Site
Shipley, BD18 3SA, United Kingdom
Research Site
Thetford, IP24 1JD, United Kingdom
Research Site
Trowbridge, BA14 8LW, United Kingdom
Research Site
Weston-super-Mare, BS24 7PR, United Kingdom
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 70000, Vietnam
Research Site
Hochiminh, 70000, Vietnam
Research Site
Huế, 530000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Placebo controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 2, 2025
Study Start
May 28, 2025
Primary Completion (Estimated)
January 11, 2027
Study Completion (Estimated)
January 11, 2027
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.