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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06292013
Other study ID # 18812
Secondary ID J3L-MC-EZEF2023-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 5, 2024
Est. completion date March 2029

Study information

Verified date April 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).


Recruitment information / eligibility

Status Recruiting
Enrollment 12500
Est. completion date March 2029
Est. primary completion date March 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have Lipoprotein(a) [Lp(a)] =175 nanomoles per liter (nmol/L). - Meet criteria of either 2a or 2b: 2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization. 2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors. Exclusion Criteria: - Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening. - Have uncontrolled hypertension - Have New York Heart Association class IV heart failure. - Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study. - Have severe renal failure, defined as - Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis. - Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of =5000 mg/g at screening Visit 1. - Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lepodisiran Sodium
Administered SC
Placebo
Administered SC

Locations

Country Name City State
Argentina Clínica Privada del Prado SRL Alberdi Córdoba
Argentina Buenos Aires Macula S.A Buenos Aires
Argentina CEMEDIC Buenos Aires
Argentina CIPREC Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CIPREC Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Consultorio Medico Investigador Principal Dr Besada Buenos Aires
Argentina Fundación favaloro para la Docencia e Investigación Médica Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Fundación Respirar Buenos Aires
Argentina Glenny Corp Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Instituto Cardiovascular de Buenos Aires Buenos Aires
Argentina Instituto Médico Especializado (IME) Buenos Aires
Argentina Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Stat Research S.A. Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CEDIC Caba Buenos Aires
Argentina Clinica Adventista Belgrano Caba Ciudad Autónoma De Buenos Aires
Argentina Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Consultorio Medico Dr Litvak Bruno Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas Ciudad de Buenos Aires Buenos Aires
Argentina Centro Médico Colón Córdoba
Argentina Instituto de Investigaciones Clínicas Córdoba Córdoba
Argentina Sanatorio Privado Duarte Quirós Córdoba
Argentina Instituto de Cardiología "Juana F. Cabral" Corrientes
Argentina MICA - Medicina e Investigación Cardiometabólica Del Viso Buenos Aires
Argentina CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Mendoza
Argentina Centro de Investigaciones Clínicas Baigorria Granadero Baigorria Santa Fe
Argentina Hospital Italiano de La Plata La Plata Buenos Aires
Argentina CIMeL Clinical Research Lanus Buenos Aires
Argentina Centro de Investigaciones Médicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto de Cardiología Wolff Mendoza
Argentina Clínica Privada Independencia Munro Buenos Aires
Argentina Centro Privado de Medicina Respiratoria Paraná Entre Ríos
Argentina Instituto De Investigaciones Clinicas Quilmes Quilmes Buenos Aires
Argentina DIM Clínica Privada Ramos Mejía Buenos Aires
Argentina Instituto Médico Río Cuarto Río Cuarto Córdoba
Argentina Fundacion Estudios Clinicos Rosario Santa Fe
Argentina Hospital Provincial del Centenario Rosario Santa Fe
Argentina INECO Neurociencias Oroño Rosario Santa Fe
Argentina Instituto de Especialidades de la Salud Rosario Rosario Santa Fe
Argentina Instituto de Investigaciones Clinicas Rosario Rosario Santa Fe
Argentina Instituto Médico Catamarca IMEC Rosario Santa Fe
Argentina Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica Rosario Santa Fe
Argentina Laboratorio de Hemostasia y Trombosis Rosario Santa Fe
Argentina Centro Cardiovascular Salta Salta
Argentina Corporación Médica San Martín San Martín Buenos Aires
Argentina Centro Modelo de Cardiología San Miguel de Tucuman Tucumán
Argentina Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L San Miguel de Tucuman Tucumán
Argentina Investigaciones Clínicas Tucumán San Miguel de Tucuman Tucumán
Argentina Go Centro Medico San Nicolás San Nicolas Buenos Aires
Argentina Centro de Diagnóstico y Rehabilitación (CEDIR) Santa Fe
Argentina Centro de Investigaciones Clinicas del Litoral Santa Fe
Argentina Clínica de Nefrología, Urología y Enfermedades Cardiovasculares Santa Fe
Argentina Sanatorio San Martin Venado Tuerto Santa Fe
Australia Adelaide Cardiology Adelaide South Australia
Australia Fusion Clinical Research Adelaide South Australia
Australia Nightingale Research Adelaide South Australia
Australia Paratus Clinical Research Western Sydney Blacktown New South Wales
Australia Optimus Clinical Research Botany New South Wales
Australia Cholesterol Care Brisbane Queensland
Australia Core Research Group Brisbane Queensland
Australia Heart of Australia Brisbane Queensland
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Northern Beaches Clinical Research Brookvale New South Wales
Australia Paratus Clinical Research Canberra Bruce Australian Capital Territory
Australia Emeritus Research Camberwell Victoria
Australia Victorian Heart Hospital Clayton Victoria
Australia Barwon Health Geelong Victoria
Australia Austin Health - Repatriation Hospital Heidelberg West Victoria
Australia Paratus Clinical Research Brisbane Herston Queensland
Australia GenesisCare Joondalup Western Australia
Australia Paratus Clinical Research Central Coast Kanwal New South Wales
Australia Liverpool Hospital Liverpool New South Wales
Australia Logan Hospital Meadowbrook Queensland
Australia AusTrials - Sunshine Melbourne Victoria
Australia The AIM Centre / Hunter Diabetes Centre Merewether New South Wales
Australia Mount Isa Base Hospital Mount Isa Queensland
Australia Advara HeartCare - Mulgrave Mulgrave Victoria
Australia Clinitrials Perth Western Australia
Australia AusTrials - St. Leonards Sydney New South Wales
Australia The Townsville Hospital Townsville Queensland
Austria Krankenhaus St. Josef Braunau Braunau Oberösterreich
Austria VIVIT Feldkirch Vorarlberg
Austria Medizinische Universitaet Innsbruck Innsbruck Tirol
Austria Konventhospital der Barmherzigen Brüder Linz Linz Oberösterreich
Austria Ordensklinikum Linz GmbH Elisabethinen Linz Oberösterreich
Austria Landesklinikum Mistelbach Mistelbach Niederösterreich
Austria Uniklinikum Salzburg Salzburg
Austria Universitätsklinikum St. Pölten St. Polten Niederösterreich
Austria Herz Zentrum Währing - Innere Medizin und Kardiologie | Alle Kassen und Privat Vienna Wien
Austria Medizinische Universität Wien Vienna Wien
Austria Medizinische Universität Wien Vienna Wien
Austria Zentrum für klinische Studien Dr Hanusch Gmbh Vienna Wien
Austria Klinik Floridsdorf Wien
Austria Klinik Hietzing Wien
Austria Klinik Landstraße Wien
Belgium ZNA Middelheim Antwerp Antwerpen
Belgium Imelda General Hospital Bonheiden Antwerpen
Belgium Algemeen Ziekenhuis klina Brasschaat Antwerpen
Belgium Centre Hospitalier Universitaire Brugmann Brussels Bruxelles-Capitale, Région De
Belgium Cliniques universitaires Saint-Luc Brussels Bruxelles-Capitale, Région De
Belgium Université Libre de Bruxelles - Hôpital Erasme Brussels Bruxelles-Capitale, Région De
Belgium AZ Sint-Blasius Dendermonde Oost-Vlaanderen
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium Ziekenhuis Oost-Limburg, Campus St.-Jan Genk Limburg
Belgium AZ Maria Middelares Gent Oost-Vlaanderen
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium Grand Hôpital de Charleroi Gilly Hainaut
Belgium Jessa Ziekenhuis Hasselt Limburg
Belgium AZ Groeninge Campus Kennedylaan Kortrijk West-Vlaanderen
Belgium UZ Leuven Leuven Vlaams-Brabant
Belgium AZ Sint-Maarten, Campus Leopoldstraat 2 Mechelen Antwerpen
Belgium Az Damiaan vzw Oostende West-Vlaanderen
Brazil Centro de Pesquisa Clinica do Coracao Aracaju Sergipe
Brazil Instituto Aramari Apo Asa Norte
Brazil Hospital Universitário João de Barros Barreto Belem Pará
Brazil Consultoria em Controle de Infecção Hospitalar Belo Horizonte Minas Gerais
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Brazil Hospital Pro-Cardiaco Rio de Janeiro
Brazil Hospital São Lucas Copacabana Rio de Janeiro
Brazil IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro
Brazil Instituto D'Or Pesquisa e Ensino Rio de Janeiro
Brazil Hospital Ana Nery (HAN) - Salvador Salvador Bahia
Brazil Hospital Da Bahia Salvador Bahia
Brazil Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador Salvador Bahia
Brazil Faculdade de Medicina do ABC Santo Andre São Paulo
Brazil Praxis Pesquisa Medica Santo Andre São Paulo
Brazil Centro Multidisciplinar de Estudos Clinicos Sao Bernardo do Campo São Paulo
Brazil Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto São Paulo
Brazil Centro Internacional de Pesquisa Clínica (CIPES) São José dos Campos São Paulo
Brazil CPCLIN Sao Paulo São Paulo
Brazil Hospital Alemao Oswaldo Cruz Sao Paulo São Paulo
Brazil Incor - Instituto do Coracao Sao Paulo São Paulo
Brazil CEPIC - Centro Paulista de Investigação Clínica São Paulo
Brazil CPQuali Pesquisa Clínica São Paulo
Brazil Hospital 9 De Julho São Paulo
Brazil Hospital BP São Paulo
Brazil Hospital do Coracao São Paulo
Brazil Instituto Dante Pazzanese de Cardiology São Paulo
Brazil Núcleo de Pesquisa Clínica da Rede São Camilo São Paulo
Brazil Instituto de Molestias Cardiovasculares de Tatui Tatui São Paulo
Brazil Eurolatino Pesquisas Medicas Uberlandia Minas Gerais
Brazil CEDOES Vitória Espírito Santo
Brazil Integral Pesquisa e Ensino Votuporanga São Paulo
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Canada Ecogene-21 Chicoutimi Quebec
Canada Viacar Recherche Clinique Greenfield Park Quebec
Canada Hamilton Medical Research Group Hamilton Ontario
Canada Cardio Health Clinical Trial - London London Ontario
Canada G A Research Associates Moncton New Brunswick
Canada Fraser Clinical Trials Inc New Westminster British Columbia
Canada North York Diagnostic and Cardiac Centre North York Ontario
Canada Oakville Cardiovascular Research LP Oakville Ontario
Canada Clinique des Maladies Lipidiques de Québec Québec Quebec
Canada Diex Recherche Joliette Saint-Charles-Borromée Quebec
Canada Unité de Recherche Clinique du CISSS des Laurentides St-Jerome Quebec
Canada Cardio Health Clinical Trial - St. Thomas St. Thomas Ontario
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Canada Care Access - Cape Breton Sydney Nova Scotia
Canada Centre de Medecine Metabolique de Lanaudiere (CMML) Terrebonne Quebec
Canada Corcare Toronto Ontario
Canada Diabetes Heart Research Centre Toronto Ontario
Canada Diex Recherche Trois-Rivieres Trois-Rivieres Quebec
Canada The Medical Arts Health Research Group Vancouver British Columbia
Canada Discovery Clinical Services Victoria British Columbia
Canada Victoria Heart Institute Foundation Victoria British Columbia
Canada Winnipeg Clinic Winnipeg Manitoba
China Beijing ChaoYang Hospital Beijing Beijing
China Beijing Friendship Hospital Beijing Beijing
China Peking University Third Hospital Beijing Beijing
China China-Japan Union Hospital Changchun Jilin
China The First Hospital of Jilin University Changchun Jilin
China Changde First People's Hospital Changde Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Changzhou Second People's Hospital Changzhou Jiangsu
China West China Hospital, Sichuan University Cheng Du Sichuan
China Sichuan Provincial People's Hospital Chengdu Sichuan
China Chifeng Hospital Chifeng Inner Mongolia
China 2nd Affiliated Hospital Chongqing Medical Universi Chongqing Chongqing
China Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Liaoning
China Shunde Hospital of Southern Medical Univesity Foshan Guangdong
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Guangzhou First People's Hospital Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China Sir Run Run Shaw Hospital Hangzhou Zhejiang
China The First Hospital of Harbin Medical University Harbin Heilongjiang
China The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
China Anhui Provincil Hospital South District Hefei Anhui
China The Second People's Hospital of Hefei Hefei Anhui
China Inner Mongolia People's Hospital Hohhot Inner Mongolia
China Huizhou Municipal Central Hospital Huizhou Guangdong
China Jinan Central Hospital Jinan Shandong
China Jinan Central Hospital Jinan Shandong
China Jingzhou Central Hospital Jingzhou Hubei
China Jining Medical University - Affiliated Hospital Jining Shandong
China Lanzhou university second hospital Lanzhou Gansu
China The First Hospital of Lanzhou University Lanzhou Gansu
China Lishui Central Hospital Lishui City Zhejiang
China The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan
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China Jiangsu Province Hospital Nanjing Jiangsu
China Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Guangxi People's Hospital Nanning Guangxi
China The First Affiliated Hospital of Nanyang Medical College Nanyang Henan
China The First Affiliated Hospital of Nanyang Medical College Nanyang Henan
China Ningbo First Hospital Ningbo Zhejiang
China Shanghai East Hospital Shanghai
China Zhongshan Hospital,Fudan University Shanghai Shanghai
China The People's Hospital of Liaoning Province Shenyang Liaoning
China Shenzhen Sun Yat-sen Cardiovascular Hospital Shenzhen Guangdong
China Siping Central People's Hospital Siping Jilin
China TEDA International Cardiovascular Hospital Tianjin Tianjin
China Tianjin Fourth Centre Hospital Tianjin Tianjin
China The First Affiliated Hospital of Xinjiang Medical University Urumchi Xinjiang
China People's Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang
China Chongqing Three Gorges Central Hospital Wanzhou Chongqing
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Renmin Hospital of Wuhan University Wuhan Hubei
China Wuhan Asia Heart Hospital Wuhan Hubei
China Wuhan University Medical College - Hubei Zhongshan Hospital Wuhan Hubei
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China Wuxi People's Hospital Wuxi Jiangsu
China Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army Xi'an Shaanxi
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China Xiamen Cardiovascular Hospital Xiamen Fujian
China Shaanxi provincial people's hospital Xian Shaanxi
China The Affiliated Hospital of Xuzhou Medical College Xuzhou Jiangsu
China General Hospital of Ningxia Medical University Yinchuan
China The First People's Hospital of Yueyang Yueyang Hunan
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Czechia Kardiologicka ambulance Brandýs nad Labem-Stará Boleslav Praha-východ
Czechia EFERTUS healthcare s.r.o. Brno Brno-mesto
Czechia Fakultni Nemocnice u sv. Anny v Brne Brno Brno-mesto
Czechia Fakultni Nemocnice u sv. Anny v Brne Brno Jihomoravský Kraj
Czechia Kardiologická ambulance Brno Brno Brno-mesto
Czechia Vojenská Nemocnice Brno Brno Brno-mesto
Czechia Kardioma Kolin Stredoceský Kraj
Czechia Kardiologicka ambulance Litovel Olomoucký Kraj
Czechia EDUMED - Náchod Nachod Královéhradecký Kraj
Czechia Agentura Science Pro Olomouc Olomoucký Kraj
Czechia PreventaMed Olomouc
Czechia Kardiologicka a Angiologicka Ambulance Ostrava Ostrava Mesto
Czechia Private Practice - Dr. Miroslav Koliba Ostrava Ostrava Mesto
Czechia Angiocentrum Komorany Prague Praha 12
Czechia Centrum Kardiovaskularni Mediciny Prague Praha 6
Czechia Kardio Uhrineves Prague Praha, Hlavní Mešto
Czechia Nefrologie Prague Praha 4
Czechia Poliklinika Lípa Centrum Prague Praha 13
Czechia Synexus Czech Prague Praha 2
Czechia DiaVize s.r.o. Praha Praha 4
Czechia Nova kardiologie - Kardiologicka ambulance Ricany Stredoceský Kraj
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Czechia Clinical Trials Service s.r.o. Uherské Hradište Zlínský Kraj
Czechia Cardio Research, s.r.o Zlín
Denmark Sygehus Sønderjylland i Aabenraa Aabenraa Syddanmark
Denmark Aarhus Universitetshospital, Skejby Aarhus Midtjylland
Denmark Rigshospitalet Copenhagen Hovedstaden
Denmark Sydvestjysk Sygehus Esbjerg Esbjerg Syddanmark
Denmark Sanos Clinic - Nordjylland Gandrup Nordjylland
Denmark Herlev and Gentofte Hospital Hellerup Hovedstaden
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Denmark Holbæk Sygehus Holbaek Sjælland
Denmark Sanos Clinic - Syddanmark Vejle Syddanmark
France CHU Besançon Besançon Doubs
France Hôpital Avicenne Bobigny Île-de-France
France Hospices Civils de Lyon - Hopital Louis Pradel Bron Rhône
France CHRU Troussau Chambray Les Tours Centre
France Centre Hospitalier Compiègne-Noyon Compiègne Oise
France Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand Dijon Bourgogne
France Centre Hospitalier Louis Pasteur Le Coudray Eure-et-Loir
France Hopital Claude Huriez - CHU de Lille Lille Nord
France Centre Hospitalier Saint Joseph - Saint Luc Lyon Rhône-Alpes
France Hôpital Saint Joseph Marseille Bouches-du-Rhône
France CHU Montpellier Lapeyronie Hospital Montpellier Hérault
France Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes Nantes Cedex 1 Loire-Atlantique
France CHU de Nice Nice Alpes-Maritimes
France Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau Nîmes Gard
France Hôpital Bichat - Claude-Bernard Paris
France Hôpital Européen Georges Pompidou Paris Île-de-France
France Hôpital Saint Antoine Paris Île-de-France
France Pitie Salpetriere University Hospital Paris Orne
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France Polyclinique Vauban Valenciennes
Germany Universitätsklinikum Aachen Aachen Nordrhein-Westfalen
Germany Klinikum am Plattenwald Bad Friedrichshall
Germany Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair Bad Homburg Hessen
Germany Charité Campus Virchow-Klinikum Berlin
Germany DRK Kliniken Berlin - Köpenick Berlin
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Germany Cardioangiologisches Centrum Bethanien Frankfurt Hessen
Germany Diabetes Zentrum Dr. Tews Gelnhausen Hessen
Germany Cardiologicum Hamburg Hamburg
Germany Universitätsklinikum Jena Jena Thüringen
Germany University Hospital of Cologne Köln Nordrhein-Westfalen
Germany Herzzentrum Leipzig GmbH Leipzig Sachsen
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Germany Praxis Oedeme Lüneburg Niedersachsen
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Germany Universitätsmedizin Mannheim Mannheim Baden-Württemberg
Germany ze:ro ARZTPRAXEN Mannheim Baden-Württemberg
Germany Deutsches Herzzentrum München Munich Bayern
Germany Institut für Diabetesforschung GmbH Münster Münster Nordrhein-Westfalen
Germany Kardiologische Gemeinschaftspraxis am Park Sanssouci Potsdam Brandenburg
Germany Universitätsklinikum Regensburg Regensburg Bayern
Germany Universitaet zu Koeln - Sana-Klinikum Remscheid GmbH - Klinik fuer Kardiologie, Pneumologie und Internisti -T Remscheid Nordrhein-Westfalen
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Greece Athens Medical Center Athens Attikí
Greece Athens Naval Hospital Athens Attikí
Greece General Hospital of Athens Laiko Athens Attikí
Greece Attikon General University Hospital Chaidari Attikí
Greece University General Hospital of Heraklion Heraklion Irakleío
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Hungary DRC Gyógyszervizsgáló Központ Balatongyorok Veszprém
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Hungary Szent Margit Rendelointézet Nonprofit Kft Budapest
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India Shri Mahant Indiresh Hospital Dehradun Uttarakhand
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India Government Medical College - Kozhikode Kozhikode Kerala
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India Vijan Hospital & Research Centre Nashik Maharashtra
India G.B. Pant Institute of Postgraduate Medical Education & Research New Delhi Delhi
India All India Institute of Medical Sciences Raipur Chhattisgarh
Israel Soroka Medical Center Be'er Sheva HaDarom
Israel Carmel Hospital Haifa ?eifa
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Israel Edith Wolfson Medical Center Holon HaMerkaz
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Israel Kaplan Medical Center Rehovot HaMerkaz
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Korea, Republic of The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon-si Kyonggi-do
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Korea, Republic of Chonnam National University Hospital Gwangju-si Kwangju-Kwangyokshi
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Korea, Republic of Korea University Anam Hospital Seoul Seoul-teukbyeolsi [Seoul]
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Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul Seoul-teukbyeolsi [Seoul]
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Korea, Republic of The Catholic University Of Korea St. Vincent's Hospital Suwon-si Kyonggi-do
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Netherlands Radboudumc Nijmegen Gelderland
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Netherlands Erasmus Medisch Centrum Rotterdam Zuid-Holland
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Netherlands Antonius Ziekenhuis, locatie D&A Research and Genetics Sneek Fryslân
Netherlands ETZ TweeSteden Tilburg Noord-Brabant
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Poland Specderm Poznanska Bialystok Podlaskie
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Poland AKA-MED Centrum Ruda Slaska Slaskie
Poland Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M. Zabówka E. Zabówka Tarnow Malopolskie
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Poland NZOZ Centurm Medyczne SERAFIN-MED Zarow Dolnoslaskie
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Romania C.M.D.T.A. Neomed Brasov
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Romania Centrul Medical NutriLife Bucharest Bucure?ti
Romania Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului Bucharest Bucure?ti
Romania Nicodiab Bucharest Bucure?ti
Romania Spitalul Universitar de Urgen?a Bucure?ti Bucure?ti
Romania Mat Cord Biomedica S.R.L. Buzau Buzau
Romania Spitalul Clinic Jude?ean de Urgen?a Craiova Dolj
Romania Diamed Obesity Gala?i
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Romania Clinica Korall Satu Mare
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Romania Cardiomed Târgu Mure? Mure?
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Romania Private Practice - Dr. Cristian Podoleanu Târgu-Mure? Mure?
Romania Institutul de Boli Cardiovasculare Timi?oara Timi?oara Timi?
Romania Cabinet Medical Dr.Geru Timisoara Timi?
Slovakia Cliniq s.r.o. Bratislava Bratislavský Kraj
Slovakia ENDIAMED s.r.o Dolny Kubin Žilinský Kraj
Slovakia JM-Interna s.r.o Dolny Kubin Žilinský Kraj
Slovakia Human Care s.r.o. Kosice Košický Kraj
Slovakia NEDÚ - Národný endokrinologický a diabetologický ústav n.o. Lubochna Žilinský Kraj
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Slovakia Fakultná nemocnica Nitra Nitra Nitriansky Kraj
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Spain Parc de Salut Mar - Hospital del Mar Barcelona Barcelona [Barcelona]
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United States American Clinical Trials - Acworth Acworth Georgia
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United States Rapid Medical Research Beachwood Ohio
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United States Jadestone Clinical Research Beltsville Maryland
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United States Birmingham Clinical Research Birmingham Alabama
United States Excel Medical Clinical Trials Boca Raton Florida
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United States Grace Research - Bossier Bossier City Louisiana
United States Brigham and Women's Hospital Diabetes Program Boston Massachusetts
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United States Velocity Clinical Research, Mt. Auburn Cincinnati Ohio
United States Velocity Clinical Research, Springdale Cincinnati Ohio
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United States Clinical Research of West Florida, Inc. (Clearwater) Clearwater Florida
United States Cleveland Clinic Cleveland Ohio
United States Alpine Research Organization Clinton Utah
United States Kur Research - Columbia Medical Columbia Maryland
United States Aventiv Research Inc Columbus Ohio
United States Ohio State University Columbus Ohio
United States South Texas Clinical Research Corpus Christi Texas
United States Good Samaritan Regional Medical Center Corvallis Oregon
United States Valley Clinical Trials, Inc. Covina California
United States Baylor Soltero CV Research Center Dallas Texas
United States Cedar Health Research Dallas Texas
United States Private Practice - Dr. James E. Race Dallas Texas
United States UT Southwestern Medical Center Dallas Texas
United States Zenos Clinical Research Dallas Texas
United States Alliance for Multispecialty Research, LLC Daphne Alabama
United States Alliance for Multispecialty Research, LLC. Dearborn Michigan
United States Revival Research Institute - Dearborn Dearborn Michigan
United States Cardio Voyage Denison Texas
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United States SEC Clinical Research Dothan Alabama
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United States Virginia Heart Falls Church Virginia
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United States Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC Gilbert Arizona
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United States Physician's East Endocrinology Greenville North Carolina
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United States Medi-Lab Diagnostic Gulfport Mississippi
United States Clinical Investigation Specialists Gurnee Illinois
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United States Amir A Hassan, MD, PA Houston Texas
United States Center for Cardiometabolic Disease Prevention/Baylor College of Medicine Houston Texas
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United States Juno Research Houston Texas
United States Accurate Clinical Research, Inc Humble Texas
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United States MedStar Health Research Institute (MedStar Physician Based Research Network) Hyattsville Maryland
United States Indiana University Health Methodist Hospital Indianapolis Indiana
United States 310 Clinical Research Inglewood California
United States Encore Research Group- Jacksonville Center for Clinical Research Jacksonville Florida
United States Westside Center for Clinical Research Jacksonville Florida
United States Clinical Investigation Specialists Kenosha Wisconsin
United States Marian David, MD, P.C. Kew Gardens New York
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United States Scripps Whittier Diabetes Institute La Jolla California
United States UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California
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United States Long Island Cardiovascular Consultants Lake Success New York
United States First Valley Medical Group Lancaster California
United States Lancaster General Hospital Lancaster Pennsylvania
United States Clearwater Cardiovascular & Interventional Consultants M.D., P.A. Largo Florida
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United States Walker Family Care Little River South Carolina
United States Cardiology and Medicine Clinic Little Rock Arkansas
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United States MemorialCare Health System - Long Beach Medical Center Long Beach California
United States Cardiovascular Research Foundation of Southern California Los Angeles California
United States Keck School of Medicine of USC Los Angeles California
United States The Heart Institute of East Texas Lufkin Texas
United States East Coast Institute for Research at The Jones Center Macon Georgia
United States K2 Medical Research - Maitland Maitland Florida
United States South Florida Clinical Research Institute Margate Florida
United States Care Access - Mauldin Mauldin South Carolina
United States Biopharma Informatic, LLC McAllen Texas
United States North Texas Research Associates McKinney Texas
United States Texas Institute of Cardiology, PA McKinney Texas
United States Wellness Clinical Research McKinney Texas
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United States PRX Research Mesquite Texas
United States Southern Endocrinology Associates Mesquite Texas
United States Suncoast Research Group Miami Florida
United States Inpatient Research Clinic Miami Lakes Florida
United States Alliance for Multispecialty Research, LLC Mobile Alabama
United States Mobile Heart Specialists Mobile Alabama
United States IMA Clinical Research Monroe Louisiana
United States Exemplar Research Morgantown West Virginia
United States IMA Clinical Research Mount Airy Mount Airy North Carolina
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United States Intermountain Medical Center Murray Utah
United States Advanced Research for Health Improvement, LLC Naples Florida
United States Alliance for Multispecialty Research, LLC New Orleans Louisiana
United States Icahn School of Medicine at Mount Sinai New York New York
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United States Lenox Hill Hospital New York New York
United States NYU Langone Health New York New York
United States NYU Langone Health New York New York
United States Alliance for Multispecialty Research, LLC Norfolk Virginia
United States Renstar Medical Research Ocala Florida
United States Elixia Central Florida Orlando Florida
United States Florida Institute For Clinical Research, LLC Orlando Florida
United States Desert Oasis Healthcare Medical Group Palm Springs California
United States Alliance for Multispecialty Research, LLC Park Ridge Illinois
United States AMZERN Clinical Trial Organization Peoria Arizona
United States Clinical Research of Philadelphia Philadelphia Pennsylvania
United States Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania
United States Absolute Clinical Research Phoenix Arizona
United States Elite Clinical Studies Phoenix Arizona
United States Helios Clinical Research - Phoenix Phoenix Arizona
United States AHN Allegheny General Hospital Pittsburgh Pennsylvania
United States Keystone Clinical Studies Plymouth Meeting Pennsylvania
United States Innovative Research Institute - Port Charlotte Port Charlotte Florida
United States Peace River Cardiovascular Center Port Charlotte Florida
United States Progressive Medical Research Port Orange Florida
United States Accellacare - Raleigh Raleigh North Carolina
United States Monument Health Rapid City Hospital Rapid City South Dakota
United States Eastside Research Associates Redmond Washington
United States Northwell Health Physician Peconic Riverhead New York
United States University of Rochester Medical Center Rochester New York
United States Clearwater Cardiovascular & Interventional Consultants M.D., P.A. Safety Harbor Florida
United States StudyMetrix Research Saint Peters Missouri
United States Clinical Advancement Center San Antonio Texas
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Diagnostics Research Group San Antonio Texas
United States Endeavor Clinical Trials San Antonio Texas
United States Artemis Institute for Clinical Research San Diego California
United States Care Access - Santa Clarita Santa Clarita California
United States Saratoga Clinical Research Saratoga Springs New York
United States Consano Clinical Research, LLC Shavano Park Texas
United States DaVita Clinical Research - North Houston Shenandoah Texas
United States Revival Research Institute - Sherman Sherman Texas
United States Sherman Clinical Research Sherman Texas
United States Millennium Clinical Trials Simi Valley California
United States Louisiana Heart Center - Slidell Slidell Louisiana
United States Cardio Metabolic Institute Somerset New Jersey
United States Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Springfield Illinois
United States Cardiology Associates of Fairfield County, P.C. Stamford Connecticut
United States Stanford University Medical Center Stanford California
United States Stony Brook University Stony Brook New York
United States Atlantic Health System Overlook Medical Center Summit New Jersey
United States Clinical Research Institute of Arizona (CRI) - Sun City West Sun City West Arizona
United States Olive View-UCLA Medical Center Sylmar California
United States Care Access - Tampa Tampa Florida
United States Clinical Research of West Florida Tampa Florida
United States Care Access - Thousand Oaks Thousand Oaks California
United States Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. Toluca Lake California
United States Cotton O'Neil Clinical Research Center - Central Office Topeka Kansas
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States UCLA South Bay Endocrinology Torrance California
United States Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
United States Eclipse Clinical Research Tucson Arizona
United States Synexus Clinical Research US, Inc./Orange Grove Family Practice Tucson Arizona
United States Preferred Primary Care Physicians Uniontown Pennsylvania
United States InvivoCure Van Nuys California
United States Synexus Clinical Research US - Vista Vista California
United States IMA Clinical Research Warren Warren New Jersey
United States MedStar Washington Hospital Center Washington District of Columbia
United States Chase Medical Research, LLC Waterbury Connecticut
United States Cardiology Partners Clinical Research Institute - Wellington Wellington Florida
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
United States Interventional Cardiology Medical Group West Hills California
United States Accellacare - Wilmington Wilmington North Carolina
United States Accellacare - DuPage Winfield Illinois
United States Wake Forest Baptist Health Winston-Salem North Carolina
United States Cardiology Consultants of Philadelphia Yardley Yardley Pennsylvania
United States Heart and Vascular Research at WellSpan Health York Pennsylvania
United States Michigan Heart & Vascular Institute Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Romania,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and urgent coronary revascularization. Baseline up to End of Study (About 4.5 Years)
Secondary Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4 Change from Baseline in Lp(a) Baseline, Week 4
Secondary Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint Time to first occurrence MACE-3 Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction Time to first occurrence of fatal or non-fatal myocardial infarction. Baseline up to End of Study (About 4.5 Years)
Secondary Time to Cardiovascular Death Time to cardiovascular death. Baseline up to End of Study (About 4.5 Years)
Secondary Time to Occurrence of All-Cause Death Time to occurrence of all-cause death Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization) Time to first occurrence of any component of the MACE-4 composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event) Time to first occurrence of any component of the MACE-4 composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) = 200 nmol/L) Time to first occurrence of any component of the MACE-4 composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint Time to first occurrence of any component of MACE-3 + MALE composite endpoint. Baseline up to End of Study (About 4.5 Years)
Secondary Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint Time to first Occurrence of any component of coronary MACE-3 composite endpoint. Baseline up to End of Study (About 4.5 Years)

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