A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event
Launched by ASTRAZENECA · May 30, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called AZD0780 to see if it can help reduce serious heart-related events in patients who have a history of cardiovascular disease or are at high risk for developing it. The trial is in its third phase, which means it’s one of the final steps before the medication could be approved for use. Participants will be divided into two groups: one will receive the AZD0780 medication, and the other will receive a placebo, which looks like the medication but has no active ingredients. The researchers will monitor participants for heart-related events over a set period to see if AZD0780 is effective.
To be eligible for this trial, participants must be at least 18 years old and either have a history of heart problems or be at high risk for a first heart event. For instance, they may have high cholesterol levels or other health issues like diabetes. Participants will need to be on a stable cholesterol-lowering medication before joining the study. Those who decide to participate can expect regular check-ups and monitoring throughout the trial, which is not yet recruiting participants, meaning it has not started enrolling patients. This study aims to provide more information about how AZD0780 can potentially improve heart health for those at risk.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Meets one of the following:
- • 1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of ASCVD defined as ACS within 1 to 12 months prior to randomisation, or large artery ischaemic stroke suspected to be due to atherosclerotic vascular disease within 1 to 12 months prior to randomisation, or revascularisation for symptomatic lower limb PAD, and LDL-C ≥ 60 mg/dL (≥ 1.55 mmol/L).
- Additional risk factors based on the level of the screening LDL-C:
- • o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors below.
- • T2DM requiring ongoing medical therapy
- • Age ≥ 65 years
- • Previous above ankle amputation due to PAD
- • Previous diagnosis of non-end stage CKD
- 2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) and diagnostic evidence of at least one of the following disease categories (i, ii, or iii):
- • i) Significant atherosclerotic artery disease
- • ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of end-organ disease (diabetic nephropathy, retinopathy, neuropathy or an ABI outside the normal range \[0.9 to 1.4\])
- • iii) Documented atherosclerosis of less significance
- For ii) and iii), participants need to have at least one of the additional risk factors below:
- • 1. CKD with eGFR ≤ xx mL/min/1.73 m2
- • 2. Current tobacco use
- • 3. Age ≥ 65
- • 4. T2DM (if included on the less significant atherosclerosis criterion iii)
- • Participant should be receiving a maximally tolerated lipid-lowering regimen including a maximally tolerated dose of a statin.
- • 1. Participants who are judged by the treating physician not to tolerate high-intensity statins (according to guidelines, typically, atorvastatin ≥ 40 mg once daily or rosuvastatin ≥ 20 mg once daily) may be included if treated with a low or moderate intensity statin dose.
- • 2. Participants not receiving any statins must have documented intolerable side effects to at least 2 different statins, including one at the lowest standard dose or on a chronic medication that would prohibit the use of a statin (according to the prescribing information for the statin in question).
- • 3. Participants must achieve a stable dose (\> 28 days) of lipid-lowering therapies before screening.
- Exclusion criteria:
- • Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.
- • Any revascularisation procedure planned within the next 3 months.
- • Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
- • Calculated eGFR \< 15 mL /min/1.73 m2
- * Any laboratory values with the following deviations at screening:
- • AST or ALT \> 3 × ULN
- • TBL \> 2 × ULN (except for participants with Gilbert's 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/creatinine ratio ≥ 500 mg/g
- • Uncontrolled T2DM 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 of screening or planned use during the study.
- • Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
- • Use of PCSK9 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, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Montpellier, , France
Fountain Valley, California, United States
Poway, California, United States
Miami, Florida, United States
Shreveport, Louisiana, United States
Oradea, , Romania
Crystal River, Florida, United States
Fort Lauderdale, Florida, United States
Kansas City, Missouri, United States
Barretos, , Brazil
Antofagasta, , Chile
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Mumbai, , India
Deland, Florida, United States
Waterbury, Connecticut, United States
Evansville, Indiana, United States
El Paso, Texas, United States
Berlin, , Germany
Kiel, , Germany
Milano, , Italy
San Diego, California, United States
Napoli, , Italy
Cape Town, , South Africa
Plovdiv, , Bulgaria
Dundee, , United Kingdom
Erlangen, , Germany
Torino, , Italy
Valencia, , Spain
Esbjerg, , Denmark
Bordeaux, , France
Lille, , France
Toulouse, , France
Regensburg, , Germany
Christchurch, , New Zealand
Málaga, , Spain
Madrid, , Spain
Maitland, Florida, United States
Baltimore, Maryland, United States
Debrecen, , Hungary
Gdańsk, , Poland
Mobile, Alabama, United States
Gilbert, Arizona, United States
Lancaster, California, United States
Los Angeles, California, United States
Lake Charles, Louisiana, United States
Annapolis, Maryland, United States
Duluth, Minnesota, United States
New Bern, North Carolina, United States
Chattanooga, Tennessee, United States
Tullahoma, Tennessee, United States
Sofia, , Bulgaria
Benesov, , Czechia
Herlev, , Denmark
Roskilde, , Denmark
Svendborg, , Denmark
Heidelberg, , Germany
Stuttgart, , Germany
Witten, , Germany
Budapest, , Hungary
Kalocsa, , Hungary
Szolnok, , Hungary
Zalaegerszeg, , Hungary
Pavia, , Italy
Presov, , Slovakia
Uppsala, , Sweden
Katy, Texas, United States
Novara, , Italy
Richmond, Virginia, United States
Jefferson City, Missouri, United States
Praha 5, , Czechia
Morgantown, West Virginia, United States
Lexington, Kentucky, United States
Bruchsal, , Germany
Freiburg, , Germany
Kaiserslautern, , Germany
Magdeburg, , Germany
Münster, , Germany
Potsdam, , Germany
Weinheim, , Germany
Wermsdorf, , Germany
Athens, , Greece
Foggia, , Italy
Brescia, , Italy
Inverness, Florida, United States
Palm Harbor, Florida, United States
Greensboro, North Carolina, United States
Wilmington, North Carolina, United States
Norman, Oklahoma, United States
Beverly Hills, California, United States
Dijon, , France
San Antonio, Texas, United States
Quezon City, , Philippines
Manila, , Philippines
Johannesburg, , South Africa
Kaohsiung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Chiang Mai, , Thailand
Göttingen, , Germany
Trier, , Germany
Bridgeton, Missouri, United States
Tucson, Arizona, United States
Uzhhorod, , Ukraine
Ames, Iowa, United States
Hialeah, Florida, United States
Atlanta, Georgia, United States
Jacksonville, Florida, United States
Leipzig, , Germany
Ludhiana, , India
Durban, , South Africa
Pembroke Pines, Florida, United States
Memphis, Tennessee, United States
São Paulo, , Brazil
Baguio City, , Philippines
Bloemfontein, , South Africa
Brest Cedex, , France
Marseille, , France
Rennes Cedex 9, , France
Rozzano, , Italy
Bologna, , Italy
Roma, , Italy
Thunder Bay, Ontario, Canada
Mannheim, , Germany
Szeged, , Hungary
Viborg, , Denmark
Lecco, , Italy
Missoula, Montana, United States
Zlin, , Czechia
Heraklion, , Greece
Lake Forest, California, United States
Morehead City, North Carolina, United States
Hinesville, Georgia, United States
Morganton, North Carolina, United States
Cona, , Italy
Thousand Oaks, California, United States
Winter Haven, Florida, United States
Scarborough, Maine, United States
Salt Lake City, Utah, United States
Nagpur, , India
Iloilo City, , Philippines
Bangkok, , Thailand
Herning, , Denmark
Vejle, , Denmark
Niigata Shi, , Japan
Charlottesville, Virginia, United States
Foley, Alabama, United States
Northridge, California, United States
Chicago, Illinois, United States
Saint Cloud, Minnesota, United States
Philadelphia, Pennsylvania, United States
Rapid City, South Dakota, United States
Godoy Cruz, , Argentina
Bridgewater, Nova Scotia, Canada
Cambridge, Ontario, Canada
Beijing, , China
Bad Oeynhausen, , Germany
Hohenmölsen, , Germany
Balatonfüred, , Hungary
Kaposvár, , Hungary
Szekszárd, , Hungary
Alor Setar, , Malaysia
Kota Samarahan, , Malaysia
Kuala Lumpur, , Malaysia
Kuching, , Malaysia
Kosice, , Slovakia
Zilina, , Slovakia
Centurion, , South Africa
Paarl, , South Africa
Somerset West, , South Africa
Umkomaas, , South Africa
Palma De Mallorca, , Spain
Tarragona, , Spain
Changhua, , Taiwan
Chernivtsi, , Ukraine
Sheffield, , United Kingdom
Bangor, Maine, United States
Hammond, Louisiana, United States
Paris Cedex 15, , France
Omaha, Nebraska, United States
Corpus Christi, Texas, United States
Essen, , Germany
Greifswald, , Germany
George, , South Africa
Bonn, , Germany
Ioannina, , Greece
Camp Hill, Pennsylvania, United States
Craiova, , Romania
Izmir, , Turkey
Brno, , Czechia
Parma, , Italy
Somerset, New Jersey, United States
Seoul, , Korea, Republic Of
Lima, , Peru
Miraflores, , Peru
Gdynia, , Poland
Katowice, , Poland
Ostrava, , Czechia
Garden Grove, California, United States
Columbus, Ohio, United States
Manassas, Virginia, United States
Oxon Hill, Maryland, United States
Portland, Oregon, United States
Lynwood, California, United States
San Dimas, California, United States
New Port Richey, Florida, United States
Canton, Georgia, United States
Jena, , Germany
Gwangju, , Korea, Republic Of
Dijon Cedex, , France
Phoenix, Arizona, United States
Rouen, , France
Bergamo, , Italy
Genoa, , Italy
Toruń, , Poland
Limoges, , France
Mar Del Plata, , Argentina
San Nicolás, , Argentina
Brampton, Ontario, Canada
Terrebonne, Quebec, Canada
Corbeil Essonnes, , France
Busan, , Korea, Republic Of
Jung Gu, , Korea, Republic Of
Nakhon Ratchasima, , Thailand
Vinnytsia, , Ukraine
Ho Chi Minh City, , Vietnam
Tucker, Georgia, United States
Bossier City, Louisiana, United States
Falls Church, Virginia, United States
Rosario, , Argentina
Ostrava Dubina, , Czechia
Paris 14, , France
Veszprém, , Hungary
Asahi Shi, , Japan
Kishiwada Shi, , Japan
Kyoto Shi, , Japan
Suwa Shi, , Japan
Bucheon Si, , Korea, Republic Of
Ostrów Mazowiecka, , Poland
Tarnów, , Poland
Alicante, , Spain
Ivano Frankivsk, , Ukraine
Ho Chi Minh, , Vietnam
Sao Paulo, , Brazil
Karlsruhe, , Germany
Montreal, Quebec, Canada
Perugia, , Italy
Sugar Land, Texas, United States
Córdoba, , Argentina
Quebec, , Canada
Osorno, , Chile
Benatky Nad Jizerou, , Czechia
Cesky Krumlov, , Czechia
Pribram Viii, , Czechia
Aarhus N, , Denmark
Lyon, , France
Hannover, , Germany
Piraeus, , Greece
Falun, , Sweden
London, , United Kingdom
Hillerød, , Denmark
Catania, , Italy
Pordenone, , Italy
Strasbourg Cedex, , France
Ankara, , Turkey
Dublin, Ohio, United States
Tours Cedex 9, , France
Taoyuan, , Taiwan
Bowling Green, Kentucky, United States
Kure Shi, , Japan
Duesseldorf, , Germany
Ludwigshafen, , Germany
Palmetto Bay, Florida, United States
Fremont, Nebraska, United States
Las Vegas, Nevada, United States
Monroe, North Carolina, United States
Smithfield, Pennsylvania, United States
Houston, Texas, United States
Fairhope, Alabama, United States
Pharr, Texas, United States
Bountiful, Utah, United States
Kenosha, Wisconsin, United States
Talcahuano, , Chile
Praha, , Czechia
Trebic, , Czechia
Dresden, , Germany
Hamburg, , Germany
Markkleeberg, , Germany
Schwerin, , Germany
Pécs, , Hungary
Bangalore, , India
New Delhi, , India
Rivoli, , Italy
Fujisawa Shi, , Japan
Koga Shi, , Japan
Okayama Shi, , Japan
Changwon Si, , Korea, Republic Of
Daegu, , Korea, Republic Of
Davao City, , Philippines
Rzeszów, , Poland
Santiago(a Coruña), , Spain
Hsinchu, , Taiwan
Hat Yai, , Thailand
Antalya, , Turkey
Lutsk, , Ukraine
Edirne, , Turkey
Kayseri, , Turkey
łódź, , Poland
Winfield, Illinois, United States
San Juan, , Argentina
Pretoria, , South Africa
Pikesville, Maryland, United States
Wilkes Barre, Pennsylvania, United States
Sherbrooke, Quebec, Canada
Békéscsaba, , Hungary
Ichikawa Shi, , Japan
Taipei City, , Taiwan
Frankfurt, , Germany
Hai Phong, , Vietnam
Can Tho, , Vietnam
Yilan, , Taiwan
Santa Rosa, , Argentina
Vijayawada, , India
Daejeon, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Bellavista, , Peru
New Taipei, , Taiwan
Hue, , Vietnam
Levice, , Slovakia
Pearland, Texas, United States
Kuantan, , Malaysia
Alexandroupolis, , Greece
Tokushima Shi, , Japan
Praha 4, , Czechia
Ushiku Shi, , Japan
Riverdale, Georgia, United States
Wiesbaden, , Germany
Papatoetoe, , New Zealand
Bad Homburg, , Germany
Jerichow, , Germany
Speyer, , Germany
Porto Alegre, , Brazil
Toronto, Ontario, Canada
Gurgaon, , India
Benoni, , South Africa
Harefield, , United Kingdom
Canoga Park, California, United States
Davao, , Philippines
Saraland, Alabama, United States
Arzignano, , Italy
Toride Shi, , Japan
Valdivia, , Chile
Valenciennes, , France
Haßloch, , Germany
Vinnytsya, , Ukraine
Dolný Kubín, , Slovakia
Humble, Texas, United States
Mesquite, Texas, United States
Campinas, , Brazil
Newmarket, Ontario, Canada
North York, Ontario, Canada
Belagavi, , India
Nagasaki Shi, , Japan
Suita Shi, , Japan
San Miguel De Tucuman, , Argentina
Kobe Shi, , Japan
Chorrillos, , Peru
Marikina, , Philippines
Lake City, Florida, United States
San Isidro, , Peru
Owensboro, Kentucky, United States
Brasilia, , Brazil
Seri Manjung, , Malaysia
Nitra, , Slovakia
Vigo, , Spain
Kanazawa Shi, , Japan
Dehradun, , India
Tirgu Mures, , Romania
München, , Germany
Maplewood, Minnesota, United States
Durham, North Carolina, United States
A Coruna, , Spain
Caserta, , Italy
Caba, , Argentina
Cordoba, , Argentina
Blumenau, , Brazil
Utsunomiya Shi, , Japan
Sanlúcar De Barrameda (Cádiz), , Spain
Villamartín (Cádiz), , Spain
Herne, , Germany
Bielefeld, , Germany
Lund, , Sweden
Manipal, , India
Goiania, , Brazil
Yokohama Shi, , Japan
Hyderabad, , India
København, , Denmark
Stoney Creek, Ontario, Canada
Norco, California, United States
Encs, , Hungary
Yongin Si, , Korea, Republic Of
Nunoa, , Chile
Wanchac, , Peru
Paris, , France
Kolkata, , India
Istanbul, , Turkey
Belem, , Brazil
Alingsås, , Sweden
Bristol, , United Kingdom
Lanus Este, , Argentina
Kobe, , Japan
Brezno, , Slovakia
Klong Luang, , Thailand
Tanabe Shi, , Japan
Piura, , Peru
Orlando, Florida, United States
Luebeck, , Germany
Urayasu Shi, , Japan
Munich, , Germany
Heilbronn, , Germany
Tamana Shi, , Japan
Zapopan, , Mexico
Liberec 2, , Czechia
Ruda śląska, , Poland
Trois Rivières, Quebec, Canada
Broumov, , Czechia
Kütahya, , Turkey
Kazımkarabekir, , Turkey
Kanoya Shi, , Japan
Suncheon, , Korea, Republic Of
Murcia, , Spain
Carmel, Indiana, United States
Vina Del Mar, , Chile
Angeles City, , Philippines
Iasi, , Romania
Beaumont, Texas, United States
Redmond, Washington, United States
Copenhagen, , Denmark
Jelenia Góra, , Poland
Concepcion, , Chile
Peachtree Corners, Georgia, United States
Bydgoszcz, , Poland
Kajang, , Malaysia
Norfolk, Virginia, United States
Sarawak Miri, , Malaysia
Khon Kaen, , Thailand
Kanpur, , India
Mueang, , Thailand
Hualien City, , Taiwan
Hiroshima Shi, , Japan
Muenster, , Germany
Hamamatsu Shi, , Japan
Matsuyama City, , Japan
Yenimahalle, , Turkey
Paris, Texas, United States
Huddinge, , Sweden
Kuala Terengganu, , Malaysia
Vadodara, , India
North Charleston, South Carolina, United States
Calow, , United Kingdom
Brownsville, Texas, United States
Rüsselsheim Am Main, , Germany
Midrand, , South Africa
Odunpazarı, , Turkey
Kasuya Gun, , Japan
Minato Ku, , Japan
Manadaluyong City, , Philippines
Wrocław, , Poland
Afyonkarahisar, , Turkey
Trnava, , Slovakia
Płock, , Poland
Sydney, Nova Scotia, Canada
Stockholm, , Sweden
Canakkale, , Turkey
Kamakura, , Japan
Hatboro, Pennsylvania, United States
Horsham, Pennsylvania, United States
Santiago, , Chile
Bron, , France
Chemnitz, , Germany
Kota Kinabalu, , Malaysia
Białystok, , Poland
Kędzierzyn Koźle, , Poland
Szczecin, , Poland
Targu Mures, , Romania
Timisoara, , Romania
Prešov, , Slovakia
Mugla, , Turkey
King's Lynn, , United Kingdom
Dwarka, , India
Ogden, Utah, United States
Larissa, , Greece
Bellville, , South Africa
Laguna, , Philippines
Kyiv, , Ukraine
Uberlândia, , Brazil
Markham, Ontario, Canada
Kingston, Ontario, Canada
Victoria, British Columbia, Canada
Nyíregyháza Sóstóhegy, , Hungary
Sevilla, , Spain
Lublin, , Poland
Castroville, California, United States
Kochi, , India
Kitakyushu, , Japan
Banphaeo, , Thailand
Hamilton, Ontario, Canada
Glasgow, , United Kingdom
Lima, Ohio, United States
Zhytomyr, , Ukraine
Fulda, , Germany
Victoria, , Chile
Obertshausen, , Germany
Offenbach Am Main, , Germany
Warszawa, , Poland
Kaohsiung City, , Taiwan
Taichung City, , Taiwan
Bacau, , Romania
Brackenfell, , South Africa
Ciudad De Buenos Aires, , Argentina
Svitavy, , Czechia
Košice, , Slovakia
Ciudad Autonoma De Bs As, , Argentina
Miyakonojo Shi, , Japan
Komatsu Shi, , Japan
Poznań, , Poland
Satu Mare, , Romania
Slagelse, , Denmark
Narbonne Cedex, , France
Bremen, , Germany
Osnabrück, , Germany
Delhi, , India
Gwangmyeong Si, , Korea, Republic Of
Brooklyn, New York, United States
Knoxville, Tennessee, United States
Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Zarate, , Argentina
Curitiba, , Brazil
Vancouver, British Columbia, Canada
Independencia, , Chile
české Budějovice, , Czechia
Bad Friedrichshall, , Germany
Berlin Lichtenberg, , Germany
Nuernberg, , Germany
Stuhr, , Germany
Ami Machi, , Japan
Osaka Shi, , Japan
Tsukuba Shi, , Japan
Urasoe Shi, , Japan
Kraków, , Poland
Bratislava, , Slovakia
Malacky, , Slovakia
Vinica, , Slovakia
Tainan, , Taiwan
Poole, , United Kingdom
Kingwood, Texas, United States
Chillán, , Chile
Hvidovre, , Denmark
Longwood, Florida, United States
Versailles, Kentucky, United States
Elkhorn, Nebraska, United States
Charleston, South Carolina, United States
Euless, Texas, United States
Ciudad De Rosario, , Argentina
Nueva Córdoba, , Argentina
Halifax, Nova Scotia, Canada
Las Condes, , Chile
Bruntal, , Czechia
Ceska Trebova, , Czechia
Gandrup, , Denmark
La Tronche, , France
Kamp Lintfort, , Germany
Karlsbad, , Germany
Mainz, , Germany
Rotenburg A.D. Fulda, , Germany
Chios, , Greece
Thessaloniki, , Greece
Ahamadabad, , India
Hydarabad, , India
New Dehli, , India
Higashiyamato Shi, , Japan
Miyazaki, , Japan
Obu, , Japan
Oita Shi, , Japan
Omura Shi, , Japan
Yokohama City, , Japan
George Town, , Malaysia
Hastings, , New Zealand
Hutt Central, , New Zealand
Palmerston North Central, , New Zealand
Pukekohe, , New Zealand
Tacloban City, , Philippines
Arad, , Romania
Bucharest, , Romania
Bucuresti, , Romania
šamorín, , Slovakia
Kimberley, , South Africa
Umhlanga Rocks, , South Africa
Umea, , Sweden
Västerås, , Sweden
Tokat, , Turkey
Birmingham, , United Kingdom
Congleton, , United Kingdom
Gateshead, , United Kingdom
Middlesex, , United Kingdom
Milton Keynes, , United Kingdom
Wirral, , United Kingdom
Danang, , Vietnam
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported