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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06383390
Other study ID # 18584
Secondary ID J1I-MC-GZBO2023-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 30, 2024
Est. completion date February 2029

Study information

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

Clinical Trial Summary

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date February 2029
Est. primary completion date February 2029
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - A Body Mass Index of =27.0 kilograms per meter squared (kg/m^2) - Participants may be with or without type 2 diabetes (T2D) unless their hemoglobin A1c (HbA1c) is 10% or lower - Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following: - Coronary artery disease - Cerebrovascular disease - Peripheral arterial disease - Chronic kidney disease defined as: - eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g) - eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or - eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab) Exclusion Criteria: Diabetes related: - Participants have Type 1 Diabetes or history of diabetic ketoacidosis CV related: - Participants have any of the following cardiovascular conditions = 90 days prior to randomization: - Myocardial infarction - Acute coronary syndrome - Stroke, or - Coronary, peripheral, or carotid artery arterial revascularization procedure. - Have acute decompensated heart failure requiring hospitalization. - Have New York Heart Association (NYHA) Classification Class IV heart failure at screening Kidney related: - Participants have an eGFR <20 mL/min/1.73 m^2 at screening - Have UACR >5000 mg/g at screening - Have received any form of dialysis = 90 days from the date of randomization - Have either undergone a kidney transplant or have a transplant procedure scheduled Other medical conditions: - Participants have had or plan to have a surgical treatment for obesity, - Have a history of chronic or acute pancreatitis - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2 - Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

Study Design


Intervention

Drug:
Retatrutide
Administered SC
Placebo
Administered SC

Locations

Country Name City State
Argentina Buenos Aires Macula S.A Buenos Aires
Argentina Cardiología Palermo Buenos Aires
Argentina CEMEDIC Buenos Aires
Argentina Centro Médico Viamonte Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CIPREC Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CIPREC Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CONEXA Investigacion Clinica S.A. Buenos Aires
Argentina Fundación Respirar Buenos Aires
Argentina Glenny Corp Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Instituto Médico Especializado (IME) Buenos Aires
Argentina Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Stat Research S.A. Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CEMEDIAB C.a.b.a. Ciudad Autónoma De Buenos Aires
Argentina CEDIC Caba Buenos Aires
Argentina Centro Medico Privado CEMAIC Capital Córdoba
Argentina Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aires Ciudad Autónoma De 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 Medico Privado San Vicente Diabetes Cordoba Córdoba
Argentina Centro Diabetológico Dr. Waitman Córdoba
Argentina Centro Médico Colón Córdoba
Argentina CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani Córdoba
Argentina Instituto de Investigaciones Clínicas Córdoba Córdoba
Argentina Sanatorio Privado Duarte Quirós Córdoba
Argentina CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Mendoza
Argentina Centro de Investigaciones Clínicas Baigorria Granadero Baigorria Santa Fe
Argentina Centro Médico Lebensohn Junín Buenos Aires
Argentina Hospital Italiano de La Plata La Plata Buenos Aires
Argentina CIMeL Clinical Research Lanus Buenos Aires
Argentina Polo de Salud Vistalba Luján de Cuyo Mendoza
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 Clínica Privada Independencia Munro Buenos Aires
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 Medico Privado de Reumatologia SAN M. DE Tucuman Tucumán
Argentina Corporación Médica San Martín San Martín Buenos Aires
Argentina Centro Modelo de Cardiología 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 Centro de Salud e Investigaciones Médicas Santa Rosa La Pampa
Argentina Sanatorio Norte Santiago del Estero
Argentina CEREHA Sarandi Buenos Aires
Argentina Centro de Investigaciones Medicas Temperley Temperley Buenos Aires
Argentina Sanatorio San Martin Venado Tuerto Santa Fe
Argentina Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires
Australia Nightingale Research Adelaide South Australia
Australia Optimus Clinical Research Botany New South Wales
Australia Box Hill Hospital Box Hill Victoria
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Northern Beaches Clinical Research Brookvale New South Wales
Australia Emeritus Research Camberwell Victoria
Australia Canberra Hospital Garran Australian Capital Territory
Australia Barwon Health Geelong Victoria
Australia Austin Health - Repatriation Hospital Heidelberg West Victoria
Australia Liverpool Hospital Liverpool New South Wales
Australia Logan Hospital Meadowbrook Queensland
Australia The Alfred Hospital Melbourne Victoria
Australia The AIM Centre / Hunter Diabetes Centre Merewether New South Wales
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia
Australia Royal North Shore Hospital St Leonards New South Wales
Australia University of Sydney - Charles Perkins Centre Sydney New South Wales
Austria Krankenhaus St. Josef Braunau Braunau Oberösterreich
Austria VIVIT Feldkirch Vorarlberg
Austria Medizinische Universität Graz Graz Steiermark
Austria Medizinische Universitaet Innsbruck Innsbruck Tirol
Austria Konventhospital der Barmherzigen Brüder Linz Linz Oberösterreich
Austria Private Practice - Dr. Evelyn Fliesser-Gorzer Sankt Stefan ob Stainz Steiermark
Austria Imed19-privat Vienna
Austria Medizinische Universität Wien Vienna Wien
Austria Zentrum für klinische Studien Dr Hanusch Gmbh Vienna Wien
Austria Klinik Hietzing Wien
Austria Klinik Landstraße Wien
Belgium Onze Lieve Vrouw Ziekenhuis Aalst Aalst Oost-Vlaanderen
Belgium Imelda General Hospital Bonheiden Antwerpen
Belgium Algemeen Ziekenhuis klina Brasschaat Antwerpen
Belgium Cliniques universitaires Saint-Luc Brussels Bruxelles-Capitale, Région De
Belgium Université Libre de Bruxelles - Hôpital Erasme Brussels Bruxelles-Capitale, Région De
Belgium UZ Brussel Brussels Bruxelles-Capitale, Région De
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium Jessa Ziekenhuis Hasselt Limburg
Belgium Kormont Kluisbergen Oost-Vlaanderen
Belgium Kormont Kluisbergen Oost-Vlaanderen
Belgium Kormont Kluisbergen Oost-Vlaanderen
Belgium AZ Groeninge Campus Kennedylaan Kortrijk West-Vlaanderen
Belgium UZ Leuven Leuven Vlaams-Brabant
Belgium Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Liège
Belgium ZNA Jan Palfijn Merksem Vlaams Gewest
Belgium Az Damiaan vzw Oostende West-Vlaanderen
Brazil Centro de Pesquisa Clinica do Coracao Aracaju Sergipe
Brazil Hospital Universitário João de Barros Barreto Belem Pará
Brazil Consultoria em Controle de Infecção Hospitalar Belo Horizonte Minas Gerais
Brazil Santa Casa de Misericordia de Belo Horizonte Belo Horizonte Minas Gerais
Brazil AngioCor Blumenau Blumenau Santa Catarina
Brazil Chronos Pesquisa Clínica Brasília Distrito Federal
Brazil L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192 Brasília Distrito Federal
Brazil Centro de Endocrinologia Geloneze Campinas São Paulo
Brazil Centro de Pesquisa Sao Lucas Campinas São Paulo
Brazil Instituto de Pesquisa clinica de Campinas Campinas São Paulo
Brazil Instituto de Pesquisas em Saúde (IPS) Caxias do sul Rio Grande Do Sul
Brazil Centro de Diabetes Curitiba Curitiba Paraná
Brazil Cline Research Center Curitiba Paraná
Brazil Instituto Pro Renal Brasil Curitiba Paraná
Brazil Pesquisa Clínica em Diabetes - Dra Rosângela Réa Curitiba Paraná
Brazil PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR Curitiba Paraná
Brazil Instituto de Ensino e Pesquisa Clinica do Ceara Fortaleza Ceará
Brazil Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE Fortaleza Ceará
Brazil Private Practice - Dr.Miguel N. Hissa Fortaleza Ceará
Brazil Universidade Federal de Goias Goiania Goiás
Brazil Centro de Pesquisas Clínicas Dr. Marco Mota Maceio Alagoas
Brazil CPHOSP Manaus Medicina, Ensino e Pesquisa Manaus Amazonas
Brazil Centro de Pesquisa Clínica de Marília - CPCLIM Marília São Paulo
Brazil Instituto Méderi de Pesquisa e Saúde Passo Fundo Rio Grande Do Sul
Brazil Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul
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 Ruschel Medicina e Pesquisa Clínica Rio De Janeiro
Brazil Clinica Senhor do Bonfim CSB - Salvador Salvador Bahia
Brazil Hospital Da Bahia Salvador Bahia
Brazil Praxis Pesquisa Medica Santo Andre São Paulo
Brazil Pesquisare Saude Santo André 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 ISPEM - Instituto São José dos Campos em Pesquisas Médicas São José dos Campos São Paulo
Brazil BR Trials - Ensaios Clinicos e Consultoria Sao Paulo 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 Instituto de Pesquisa Clinica 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 das Clinicas FMUSP 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
Canada C-health Research Calgary Alberta
Canada Ecogene-21 Chicoutimi Quebec
Canada Med Trust Research Courtice Ontario
Canada C-health Edmonton Alberta
Canada St Josephs Healthcare Hamilton - West 5th Campus Hamilton Ontario
Canada London Regional Cancer Program London Ontario
Canada St. Joseph's Health Care London Ontario
Canada Western Centre for Public Health and Family Medicine London Ontario
Canada G A Research Associates Moncton New Brunswick
Canada North York Diagnostic and Cardiac Centre North York Ontario
Canada Lakeridge Health Oshawa Ontario
Canada Alpha Recherche Clinique Quebec
Canada Unité de Recherche Clinique du CISSS des Laurentides St-Jerome Quebec
Canada Ocean West Research Clinic Surrey British Columbia
Canada SMH Cardiology Clinical Trials Surrey British Columbia
Canada Care Access - Cape Breton Sydney Nova Scotia
Canada Corcare Toronto Ontario
Canada Toronto General Hospital Toronto Ontario
Canada Winchester District Memorial Hospital Winchester Ontario
Canada Seven Oaks General Hospital Winnipeg Manitoba
Canada Winnipeg Clinic Winnipeg Manitoba
Czechia Kardiologicka ambulance Brandýs nad Labem-Stará Boleslav Praha-východ
Czechia Fakultni Nemocnice u sv. Anny v Brne Brno Brno-mesto
Czechia Fakultni Nemocnice u sv. Anny v Brne Brno Jihomoravský Kraj
Czechia UNIVMED Brno Brno-mesto
Czechia Vojenská Nemocnice Brno Brno Brno-mesto
Czechia Nemocnice Cesky Krumlov Ceský Krumlov
Czechia Kardio Chlumec Chlumec nad Cidlinou Královéhradecký Kraj
Czechia Kardioma Kolin Stredoceský Kraj
Czechia Kardiologicka ambulance Litovel Olomoucký Kraj
Czechia EDUMED - Náchod Náchod
Czechia Agentura Science Pro Olomouc Olomoucký Kraj
Czechia Diabetologicke centrum s.r.o. Olomouc
Czechia PreventaMed Olomouc
Czechia MaderMED Ostrava Moravskoslezský Kraj
Czechia Private Practice - Dr. Miroslav Koliba Ostrava Ostrava Mesto
Czechia Kardiologicka a Angiologicka Ambulance Ostrava - Dubina Moravskoslezský Kraj
Czechia Centrum Kardiovaskularni Mediciny Prague Praha 6
Czechia Fakultni Thomayerova nemocnice Prague Praha 4
Czechia FLEDIP - Na dlouhem lanu Prague Praha, Hlavní Mešto
Czechia MEDICON Prague Praha 4
Czechia MUDr. Jana Parkanyiova Prague Praha 1
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 ResTrial s.r.o. Praha Praha 8
Czechia Diabetologie a endokrinologie, J.Venerová Praha 6 Praha, Hlavní Mešto
Czechia MUDr. Barbora Diepoltova Praha 9 - Klanovice Praha 9
Czechia Diakom, s.r.o. - Preštice Preštice Plzen-jih
Czechia Kardiologicka ambulance MUDr. Ferkl s.r.o. Trutnov
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 Herlev and Gentofte Hospital Copenhagen Hovedstaden
Denmark Sanos Clinic - Nordjylland Gandrup Nordjylland
Denmark Sanos Clinic Herlev Hovedstaden
Denmark Sanos Clinic - Syddanmark Vejle Syddanmark
France Bordeaux University Hospital - Pellegrin Bordeaux Aquitaine
France Chu Gabriel Montpied Clermont-Ferrand Puy-de-Dôme
France Centre Hospitalier Sud Francilien Corbeil-Essonnes Île-de-France
France Chu Grenoble Alpes La Tronche Isère
France Centre Hospitalier Louis Pasteur Le Coudray Eure-et-Loir
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 Groupe hospitalier Paris saint Joseph Paris Île-de-France
France Hôpital Européen Georges Pompidou Paris Île-de-France
France Pitie Salpetriere University Hospital Paris Orne
France CHU Bordeaux Haut-Leveque Pessac Aquitaine
France CHU Rangueil Toulouse cedex 9 Haute-Garonne
France Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours Indre-et-Loire
France Polyclinique Vauban Valenciennes Nord
Germany Kerckhoff-Klinik Bad Nauheim Hessen
Germany Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen Bad Oeynhausen Nordrhein-Westfalen
Germany emovis GmbH Berlin
Germany Kardiologisch-Angiologische Praxis - Herzzentrum Bremen Bremen
Germany Kath. St.-Johannes-Gesellschaft Dortmund Dortmund Nordrhein-Westfalen
Germany Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien Dresden Sachsen
Germany Universitaetsklinikum Carl Gustav Carus Dresden Dresden Sachsen
Germany ZKS Suedbrandenburg Elsterwerda Brandenburg
Germany InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen
Germany Unterfrintroper Hausarztzentrum Klinische Forschung Essen Nordrhein-Westfalen
Germany Universitätsklinikum Frankfurt Frankfurt Hessen
Germany Diabetes Zentrum Wandsbek Hamburg
Germany Diabetes Zentrum Wilhelmsburg Hamburg
Germany Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen - Heidering Hannover Niedersachsen
Germany AmBeNet GmbH Leipzig Sachsen
Germany Universität zu Lübeck - Institut für Endokrinologie und Diabetes Lübeck Schleswig-Holstein
Germany Universitätsmedizin Johannes Gutenberg Universität Mainz Mainz Rheinland-Pfalz
Germany CRS Clinical Research Services Mannheim Mannheim Baden-Württemberg
Germany Universitätsmedizin Mannheim Mannheim Baden-Württemberg
Germany Institut für Diabetesforschung GmbH Münster Münster Nordrhein-Westfalen
Germany RED-Institut GmbH Oldenburg Schleswig-Holstein
Germany Kardiologische Praxis Papenburg Papenburg Niedersachsen
Germany Zentrum für klinische Studien Saint Ingbert Saarland
Germany Nephrologisches Zentrum Villingen-Schwenningen Villingen-Schwenningen Baden-Württemberg
Germany Praxis Sauter & Sauter & Vorbach Wangen im Allgäu Baden-Württemberg
Greece Athens Medical Center Athens Attikí
Greece Athens Medical Center - Psychikon branch Athens Attikí (Region)
Greece General Hospital of Athens "G. Gennimatas" Athens Attikí
Greece General Hospital of Athens Laiko Athens Attikí
Greece University Hospital of Ioannina Ioannina Ípeiros
Greece University General Hospital of Larissa Larissa Thessalía
Greece Iatriko Paleou Falirou Medical Center Paleo Faliro Attikí (Region)
Greece 424 Military General Training Hospital Thessaloniki Thessaloníki
Greece Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki
Greece G. Gennimatas General Hospital of Thessaloniki Thessaloniki Thessaloníki
Greece Papageorgiou General Hospital of Thessaloniki Thessaloniki Thessaloníki
Hungary DRC Gyógyszervizsgáló Központ Balatongyorok Veszprém
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Óbudai Egészségügyi Centrum Budapest
Hungary Privát Doktor Egészségügyi Zrt Budapest
Hungary PVN Kutató Kft Budapest
Hungary Semmelweis University Budapest
Hungary Szent Margit Rendelointézet Nonprofit Kft Budapest
Hungary Újpesti Egészségügyi Nonprofit Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary CRU Early Phase Unit Kistarcsa Pest
Hungary Selye János Kórház Komarom Komárom-Esztergom
Hungary Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged Csongrád
Hungary Allergo-Derm Bakos Kft Szolnok Jász-Nagykun-Szolnok
Hungary Zala Megyei Szent Rafael Kórház Zalaegerszeg Zala
India Motilal Nehru Medical College Hospital Allahabad Uttar Pradesh
India Life Care Hospital and Research Centre Bangalore Karnataka
India All India Institute of Medical Sciences Bhubaneswar Odisha
India Medway Hospitals - Kodambakkam Chennai Tamil Nadu
India S C B Medical College and Hospital Cuttack Odisha
India Shri Mahant Indiresh Hospital Dehradun Uttarakhand
India K care Hospital Kanpur Uttar Pradesh
India LPS Institute of Cardiology Kanpur Uttar Pradesh
India Government Medical College - Kozhikode Kozhikode Kerala
India Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow Uttar Pradesh
India Manipal Hospitals Mysore Karnataka
India All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur Maharashtra
India Kingsway Hospitals (Best Multispeciality Hospital in Nagpur) Nagpur Maharashtra
India Shrikrishna Hrudayalaya And Critical Care Center Nagpur Maharashtra
India All India Institute of Medical Sciences New Delhi Delhi
India G.B. Pant Institute of Postgraduate Medical Education & Research New Delhi Delhi
India Sir Ganga Ram Hospital New Delhi Delhi
India All India Institute of Medical Sciences Raipur Chhattisgarh
India Nirmal Hospital Surat Gujarat
India Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute Surat Gujarat
Israel Barzilai Medical Center Ashkelon HaDarom
Israel Bnai Zion Medical Center Haifa HaTsafon
Israel Rambam Health Care Campus Haifa HaTsafon
Israel Hadassah Medical Center Jerusalem Yerushalayim
Israel Shaare Zedek Medical Center Jerusalem Yerushalayim
Israel Galilee Medical Center Nahariya HaTsafon
Israel Rabin Medical Center - Hasharon Campus Petach Tikva HaMerkaz
Israel Rabin Medical Center Petah Tikva HaMerkaz
Israel Rabin Medical Center Petah-Tikva HaMerkaz
Israel Sheba Medical Center Ramat Gan HaMerkaz
Israel Sheba Medical Center Ramat Gan HaMerkaz
Israel Kaplan Medical Center Rehovot HaMerkaz
Israel Diabetes Medical Center Tel Aviv HaMerkaz
Israel Sourasky Medical Center Tel Aviv Tell Abib
Israel Yitzhak Shamir Medical Center Zerifin HaMerkaz
Italy Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo
Italy IRCCS - AOU di Bologna Bologna
Italy Azienda Ospedaliero Universitaria S.Anna Ferrara Emilia-Romagna
Italy Ospedale San Martino Genova Liguria
Italy Centro Cardiologico Monzino Milan Milano
Italy Ospedale San Raffaele Milano
Italy A.O.U. Policlinico Paolo Giaccone Palermo Sicilia
Italy AO Santa Maria della Misericordia Perugia Umbria
Italy Azienda Ospedaliera Universitaria Pisana Pisa Toscana
Italy Azienda Ospedaliera Universitaria Pisana Pisa Toscana
Italy Fondazione Policlinico Universitario Agostino Gemelli Roma
Italy Policlinico Universitario Campus Bio-Medico Rome Roma
Italy IRCCS Policlinico San Donato San Donato Milanese Milano
Mexico Centro de Atencion al Diabetico Actopan Actopan Hidalgo
Mexico Fundación Cardiovascular de Aguascalientes A.C. Aguascalientes
Mexico Enclifar Ensayos Clínicos Farmacológicos Sc Chihuahua
Mexico Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Ciudad Madero Tamaulipas
Mexico Cryptex Investigación Clínica S.A. de C.V. Cuauhtémoc, Ciudad De México Distrito Federal
Mexico Instituto de Diabetes, Obesidad y Nutricion Cuernavaca Morelos
Mexico Investigación Nefrológica Cuernavaca Morelos
Mexico PanAmerican Clinical Research - Cuernavaca Cuernavaca Morelos
Mexico Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. Culiacan Sinaloa
Mexico Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Durango
Mexico Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia Durango
Mexico Centro de Investigación Clínica y Medicina Traslacional (CIMeT) Guadalajara Jalisco
Mexico Centro de Investigacion Medica Integral Guadalajara Jalisco
Mexico CINVEC Medica Guadalajara Jalisco
Mexico Diseno y Planeacion en Investigacion Medica Guadalajara Jalisco
Mexico Instituto Jalisciense de Investigacion en Diabetes y Obesidad Guadalajara Jalisco
Mexico Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara Jalisco
Mexico Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco
Mexico Virgen Cardiovascular Research SC Guadalajara Jalisco
Mexico Instituto Cardiovascular de León S.C. León Guanajuato
Mexico Medical Care and Research SA de CV Merida Yucatán
Mexico EME RED Hospitalaria Mérida Yucatán
Mexico Centro de Investigacion en Artritis y Osteoporosis SC Mexicali Baja California
Mexico Clinstile, S.A. de C.V. Mexico Distrito Federal
Mexico Instituto Nacional de Cardiologia Ignacio Chavez Mexico
Mexico Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City Distrito Federal
Mexico Clinica Omega Mexico City Distrito Federal
Mexico Clínicos Asociados BOCM Mexico City Distrito Federal
Mexico Hospital de Jésus, I.A.P. Mexico City Distrito Federal
Mexico Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City Distrito Federal
Mexico ProcliniQ Investigación Clínica SA de CV Mexico City Distrito Federal
Mexico RM Pharma Specialists Mexico City Distrito Federal
Mexico Cardiolink Clin Trials Monterrey Nuevo León
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Mexico Clínica García Flores SC Monterrey Nuevo León
Mexico Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Mexico IMED Internal Medicine Clin Trials Monterrey Nuevo León
Mexico Servicios de Oncología Medica Integral - Monterrey - José Benitez Monterrey Nuevo León
Mexico Unidad biomedica avanzada monterrey Monterrey Nuevo León
Mexico Clinica de Enfermedades Crónicas y de Procedimientos Especiales Morelia Michoacán
Mexico Centro de Investigacion Clinica de Oaxaca Oaxaca de Juarez Oaxaca
Mexico Boca Clinical Trials Mexico SC Puebla
Mexico Centro de Estudios Clínicos de Querétaro (CECLIQ) Querétaro
Mexico PanAmerican Clinical Research - Querétaro - Avenida Antea Querétaro
Mexico Centro de Atención e Investigación Cardiovascular del Potosí San Luis Potosí
Mexico Centro de Investigacion Cardiovascular y Metabólica Tijuana Baja California
Mexico Medimanage Research Tlalpan Distrito Federal
Mexico Arké SMO S.A de C.V Veracruz
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United States Diagnostics Research Group San Antonio Texas
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United States Clinvest Research LLC Springfield Missouri
United States Mercy Research - Smith Glynn Callaway Springfield Missouri
United States Cardiology Associates of Fairfield County, P.C. Stamford Connecticut
United States Staten Island University Hospital Staten Island New York
United States Stony Brook University Stony Brook New York
United States Universal Research Group Tacoma Washington
United States Care Access - Tamarac Tamarac Florida
United States Care Access - Tampa Tampa Florida
United States Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research Tampa Florida
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United States Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. Toluca Lake California
United States Cotton O'Neil Clinical Research Center Topeka Kansas
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 Synexus Clinical Research US, Inc./Orange Grove Family Practice Tucson Arizona
United States Clinical Renal Associates - Panoramic Science Upland Pennsylvania
United States InvivoCure Van Nuys California
United States National Institute of Clinical Research (NICR) - High Desert Victorville California
United States Synexus Clinical Research US - Vista Vista California
United States Chase Medical Research, LLC Waterbury Connecticut
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
United States Accellacare - Wilmington - 1917 Tradd Court Wilmington North Carolina
United States North Georgia Clinical Research Woodstock Georgia
United States Medrasa Clinical Research Wylie Texas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Romania,  Slovakia,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Occurrence of Composite Endpoints A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF). Randomization up to Study Completion (Approximate 248 Weeks)
Primary Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), = 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death ESKD is defined as the following individual components: persistent eGFR <15 mL/min/1.73 m^2 confirmed by a second measurement at the earliest 4 weeks after the initial measurement at the central laboratory, initiation of dialysis for at least 30 days, receiving a kidney transplant.
Sustained decline in eGFR (=40%) will be confirmed by a repeated measure 1 month after the initial result.
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) MACE-3 includes CV death, nonfatal MI, and nonfatal stroke. Randomization up to Study Completion (Approximate 248 Weeks)
Secondary Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF. Randomization up to Study Completion (Approximate 248 Weeks)
Secondary Time to Occurrence of All-Cause Death Time to all-cause death. Randomization up to Study Completion (Approximate 248 Weeks)
Secondary Time to First Occurrence of composite endpoint of = 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death Randomization up to Study Completion (Approximate 248 Weeks)
Secondary Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR =30 mg/g (0.03 mg/mg) at baseline Randomization up to Study Completion (Approximate 248 Weeks)
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