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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05556512
Other study ID # 17253
Secondary ID I8F-MC-GPIJ2022-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 11, 2022
Est. completion date October 7, 2027

Study information

Verified date June 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15374
Est. completion date October 7, 2027
Est. primary completion date October 7, 2027
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Have a body mass index (BMI) =27.0 kilogram/square meter (kg/m ²) - Are either - individuals =40 years of age with established cardiovascular disease (CVD). - CVD is defined as meeting at least one of the following: - Coronary artery disease - Cerebrovascular disease - Peripheral arterial disease OR - individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention) - women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or - women =70 years of age or men, =65 years of age with at least 2 risk factors at screening. Exclusion Criteria: - Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma - Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c =6.5% (=48 millimole/mole (mmol/mol) or fasting glucose (FG) =126 milligram/deciliter (=7.0 millimole/liter (mmol/L). - Any one of the following CV conditions within 90 days prior to screening - MI - acute coronary syndrome - stroke - coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or - acute decompensated heart failure - Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures. - Have a history of chronic or acute pancreatitis - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. - Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening - Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tirzepatide
Administered SC
Placebo
Administered SC

Locations

Country Name City State
Argentina Asociación de Beneficencia Hospital Sirio Libanés Buenos Aires Buenos Air
Argentina CEMEDIC Buenos Aires
Argentina Centro Médico Viamonte Buenos Aires Ciudad Aut
Argentina CIPREC Buenos Aires Ciudad Autónoma De Buenos Aire
Argentina CONEXA Investigacion Clinica S.A. Buenos Aires
Argentina Fundación Respirar Buenos Aires
Argentina Glenny Corp Buenos Aires Ciudad Aut
Argentina Instituto Médico Especializado (IME) Buenos Aires
Argentina Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aire
Argentina Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina CEMEDIAB C.a.b.a. Ciudad Aut
Argentina CEDIC Caba Buenos Aires
Argentina Centro Medico Privado CEMAIC Capital Córdoba
Argentina Stat Research S.A. Capital Federal Buenos Air
Argentina Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire
Argentina Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aire Buenos Air
Argentina Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires
Argentina Centro Privado de Medicina Familiar / Mindout Research Ciudad Autónoma de Buenos Aire Buenos Aires
Argentina CENUDIAB Ciudad Autónoma de Buenos Aire
Argentina Centro Medico Privado San Vicente Diabetes Cordoba Córdoba
Argentina Centro de Investigaciones Clinicas Instituto del Corazon (CICIC) Córdoba
Argentina CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani Córdoba
Argentina Clínica Privada Velez Sarsfield Córdoba
Argentina Hospital San Roque Córdoba
Argentina Instituto de Investigaciones Clínicas Córdoba Córdoba
Argentina Instituto Médico DAMIC Córdoba
Argentina Instituto Medico Strusberg Córdoba
Argentina Sanatorio Privado Duarte Quirós Córdoba
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 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 Policlinica Red OMIP Mar del Plata Buenos Air
Argentina Instituto de Cardiología Wolff Mendoza
Argentina CIAD Moron Moron Buenos Air
Argentina DIM Clínica Privada Ramos Mejía Buenos Aires
Argentina Instituto Médico Río Cuarto Río Cuarto Córdoba
Argentina Fundacion Estudios Clinicos 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 de Investigaciones Clinicas Zarate 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 CER San Juan San Juan
Argentina Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán
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 Centro de Salud e Investigaciones Médicas Santa Rosa La Pampa
Argentina Sanatorio Norte Santiago del Estero
Argentina Centro de Investigaciones Medicas Temperley Temperley Buenos Aires
Argentina Sanatorio San Martin Venado Tuerto Santa Fe
Argentina Clinica Central Villa Regina Río Negro
Argentina Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires
Australia Nightingale Research Adelaide South Australia
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Paratus Clinical Research Western Sydney Blacktown New South Wales
Australia Box Hill Hospital Box Hill Victoria
Australia Core Research Group Brisbane Queensland
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
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 Royal Hobart Hospital Hobart Tasmania
Australia GenesisCare Joondalup Western Australia
Australia Paratus Clinical Research Central Coast Kanwal New South Wales
Australia Logan Hospital Meadowbrook Queensland
Australia Baker IDI Heart and Diabetes Institute - Melbourne Melbourne Victoria
Australia The AIM Centre / Hunter Diabetes Centre Merewether New South Wales
Australia GenesisCare - Murdoch - Murdoch Drive Murdoch Western Australia
Australia Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia
Australia University of Sydney - Charles Perkins Centre Sydney New South Wales
Australia The Queen Elizabeth Hospital Woodville South Australia
Austria VIVIT Feldkirch Vorarlberg
Austria Medizinische Universität Graz Graz Steiermark
Austria Medizinische Universitaet Innsbruck Innsbruck Tirol
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 Université Libre de Bruxelles - Hôpital Erasme Brussels Bruxelles-Capitale, Région De
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium Jessa Ziekenhuis Hasselt Limburg
Belgium UZ Leuven Leuven Vlaams-Brabant
Belgium Az Damiaan vzw Oostende West-Vlaanderen
Belgium AZ Nikolaas Sint-Niklaas Oost-Vlaanderen
Brazil Centro de Pesquisa Clinica do Brasil Brasilia Distrito F
Brazil Chronos Pesquisa Clínica Brasília
Brazil Centro de Pesquisa Sao Lucas Campinas São Paulo
Brazil Instituto de Pesquisa clinica de Campinas Campinas São Paulo
Brazil Loema Instituto de Pesquisa Clinica Campinas São Paulo
Brazil Centro de Diabetes Curitiba Curitiba Paraná
Brazil Cline Research Center Curitiba Paraná
Brazil Pesquisa Clínica em Diabetes - Dra Rosângela Réa Curitiba Paraná
Brazil Centro De Diabetes Metabolismo E Endocrinologia Fortaleza Ceará
Brazil Private Practice - Dr.Miguel N. Hissa Fortaleza Ceará
Brazil Instituto Do Coracao De Marilia Marilia São Paulo
Brazil CPCLIN Natal Rio Grande Do Norte
Brazil CHN - Complexo Hospitalar de Niterói Niteroi Rio De Janeiro
Brazil Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul
Brazil IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro
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 ISPEM - Instituto São José dos Campos em Pesquisas Médicas São José dos Campos São Paulo
Brazil Instituto de Pesquisa Clinica Sao Paulo São Paulo
Brazil BR Trials - Ensaios Clinicos e Consultoria São Paulo
Brazil Conjunto Hospitalar do Mandaqui São Paulo
Brazil CPQuali Pesquisa Clínica São Paulo
Brazil Hospital 9 De Julho São Paulo
Brazil Hospital das Clinicas FMUSP São Paulo
Brazil Hospital das Clinicas FMUSP São Paulo
Brazil NotreDame Intermedica Saude S.A São Paulo
Brazil CEDOES Vitória Espírito Santo
Brazil Integral Pesquisa e Ensino Votuporanga São Paulo
Canada LMC Diabetes & Endocrinology Brampton Ontario
Canada C-health Research Calgary Alberta
Canada Ecogene-21 Chicoutimi Quebec
Canada Viacar Recherche Clinique Greenfield Park Quebec
Canada NSHA-QEII Health Sciences Centre-Dickson Bldg Halifax Nova Scotia
Canada Hamilton Medical Research Group Hamilton Ontario
Canada Wharton Medical Clinic Hamilton Ontario
Canada Manna Research Lévis Quebec
Canada G A Research Associates Moncton New Brunswick
Canada Power Clinical Research Montreal Quebec
Canada Fraser Clinical Trials Inc New Westminster British Columbia
Canada North York Diagnostic and Cardiac Centre North York Ontario
Canada Centricity Research Oshawa Oshawa Ontario
Canada Medical Trust Clinics Oshawa Ontario
Canada Manna Research Montreal Pointe-Claire Quebec
Canada Alpha Recherche Clinique Quebec
Canada ALPHA Recherche Clinique Quebec
Canada Bluewater Clinical Research Group Inc. Sarnia Ontario
Canada Synergy Medical Clinic Sherwood Park Alberta
Canada Health Sciences North Sudbury Ontario
Canada Medicor Research Sudbury Ontario
Canada Centre de Medecine Metabolique de Lanaudiere (CMML) Terrebonne Quebec
Canada Diabetes Heart Research Centre Toronto Ontario
Canada Dr. Anil K. Gupta Medicine Professional Corporation Toronto Ontario
Canada LMC Clinical Research Inc. (Bayview) Toronto Ontario
Canada Dr. M.B. Jones Inc. Victoria British Columbia
China Beijing Friendship Hospital Beijing Beijing
China Beijing Pinggu District Hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China China-Japan Union Hospital Changchun Jilin
China Beijing Tsinghua Changgung Hospital Changping Beijing
China West China Hospital of Sichuan University Cheng Du Sichuan
China Chengdu Fifth People's Hospital Chengdu Sichuan
China Chongqing General Hospital Chongqing Chongqing
China Hainan General Hospital Haikou Hainan
China The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
China Hebei Medical University - Harrison International Peace Hospital Hengshui Shi Hebei
China First Huai'an Hospital Affiliated to Nanjing Medical University Huai'an Jiangsu
China Huzhou Central Hospital Huzhou Zhejiang
China Jinan Central Hospital Jinan Shandong
China The First People's Hospital of Yunnan Province Kunming Yunnan
China Lanzhou university second hospital Lanzhou Gansu
China The First Affiliated Hospital of Henan University of Science &Technology Luoyang Shi Henan
China The Third Hospital of Nanchang Nanchang Jiangxi
China Nanjing First Hospital Nanjing Jiangsu
China Nanjing Medical University - Nanjing Jiangning Hospital Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Third People's Hospital of Hainan Province Sanya Hainan
China Shanghai 9th People hospital Shanghai Shanghai
China The People's Hospital of Liaoning Province Shenyang Liaoning
China Siping Central People's Hospital Siping Jilin
China Tianjin Medical University General Hospital Tianjin Tianjin
China Tianjin People' s Hospital Tianjin Tianjin
China Wuhan University Medical College - Hubei Zhongshan Hospital Wuhan Hubei
China Wuxi People's Hospital Wuxi Jiangsu
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China Shaanxi provincial people's hospital Xian Shaanxi
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Czechia Kardiologicka ambulance Brandýs nad Labem-Stará Boleslav
Czechia Nemocnice Cesky Krumlov Ceský Krumlo Ceský Krumlov
Czechia Asclepiades Havirov Karviná
Czechia CTC Hodonin s.r.o. Hodonin
Czechia GAE s.r.o. Jindrichuv Hradec
Czechia PreventaMed Olomouc
Czechia Kardiologicka a Angiologicka Ambulance Ostrava Ostrava Mesto
Czechia Nefrologie Prague
Czechia Poliklinika Lípa Centrum Prague Praha, Hlavní Mešto
Czechia FaraCol s.r.o. Praha Praha 5
Czechia Kardiologicka ambulance s.r.o. Pribram Príbram
Czechia Angionika Slany Stredoceský Kraj
Czechia Kardiologicka ambulance MUDr. Ferkl s.r.o. Trutnov
Czechia Cardio Research, s.r.o Zlín
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 Hôtel-Dieu du Creusot - site Harfleur Le Creusot Bourgogne
France Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren Limoges Haute-Vienne
France Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes Nantes Cedex 1 Loire-Atlantique
France Centre Hospitalier Universitaire de Nice - Hôpital l'Archet Nice Alpes-Maritimes
France Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière Paris
France Hôpital Européen Georges Pompidou Paris Île-de-France
France Centre Hospitalier Lyon Sud Pierre-Bénite Rhône
France CHU Strasbourg-Hautepierre Strasbourg Alsace
France CHU Rangueil Toulouse cedex 9 Haute-Garonne
France Groupe Hospitalier Mutualiste Les Portes du Sud Vénissieux Rhône-Alpes
Germany Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair Bad Homburg Hessen
Germany Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen Bad Oeynhausen Nordrhein-Westfalen
Germany Klinische Forschung Berlin Berlin
Germany Universitaetsklinikum Carl Gustav Carus Dresden Dresden Sachsen
Germany InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen
Germany Medizentrum Essen Borbeck Essen Nordrhein-Westfalen
Germany Private Practice - Dr. Bernd Becker Essen
Germany ClinPhenomics GmbH & Co KG Frankfurt Hessen
Germany Universitätsklinikum Frankfurt Frankfurt Hessen
Germany Universitaetsklinikum Freiburg Freiburg Baden-Württemberg
Germany Clinical Research Hamburg Hamburg
Germany Diabeteszentrum Hamburg West Hamburg
Germany AmBeNet GmbH Leipzig Sachsen
Germany Universität zu Lübeck - Institut für Endokrinologie und Diabetes Lübeck
Germany Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz Ludwigshafen am Rhein Rheinland-
Germany Institut für Diabetesforschung GmbH Münster Münster Nordrhein-
Germany Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage Münster Nordrhein-Westfalen
Germany Private Practice - Dr. Christine Kosch Pirna Sachsen
Germany Zentrum für klinische Studien Saint Ingbert Saarland
Germany Universitaetsklinikum Tuebingen Tübingen Baden-Württemberg
Germany Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob Villingen-Schwenningen
Germany Praxis Sauter & Sauter & Vorbach Wangen im Allgäu Baden-Württemberg
Greece Athens Medical Center Athens Attikí
Greece General Hospital of Athens "G. Gennimatas" 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
Greece University Hospital of Ioannina Ioannina Ioánnina
Greece General Hospital of Lamia Lamia Fthiótida
Greece University General Hospital of Larissa Larissa Thessalía
Greece Iatriko Paleou Falirou Medical Center Paleo Faliro Attikí (Region)
Greece AHEPA University General Hospital of Thessaloniki Thessaloniki Kentrikí Makedonía
Greece Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki
Greece Ippokrateio General Hospital of Thessaloniki Thessaloniki Kentrikí Makedonía
Greece Papageorgiou General Hospital of Thessaloniki Thessaloniki Thessaloníki
Greece Thermi Clinic Thessaloniki Thessaloníki
Hungary DRC Gyógyszervizsgáló Központ Balatonfüred Veszprém
Hungary Bajcsy-Zsilinszky Kórház Budapest
Hungary Clinexpert Tatabánya Ltd. Budapest
Hungary Dél-Pesti Centrumkórház Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Óbudai Egészségügyi Centrum Budapest
Hungary Semmelweis University Budapest
Hungary Strazsahegy Medicina Bt. Budapest
Hungary Szent Margit Rendelointézet Nonprofit Kft Budapest
Hungary TRANTOR'99 Bt. Anyagcsere Centrum Budapest
Hungary Újpesti Egészségügyi Nonprofit Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Flor Ferenc Hospital of Pest County Kistarcsa Pest
Hungary Selye János Kórház Komarom Komárom-Esztergom
Hungary Kanizsai Dorottya Korhaz Nagykanizsa Zala
Hungary Allergo-Derm Bakos Kft Szolnok Jász-Nagykun-Szolnok
Hungary Markusovszky Egyetemi Oktatokorhaz Szombathely Vas
Hungary Minoseg Orvoscsoport Kft Veszprem Veszprém City
India Gujarat Endocrin Pvt Ltd Ahmedabad Gujarat
India Sardar Patel Medical College Bikaner Rajasthan
India Osmania General Hospital Hyderabad Telangana
India King George's Medical University Lucknow Uttar Pradesh
India Dayanand Medical College and Hospital Ludhiana Punjab
India King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College Mumbai Maharashtra
India Sir JJ Group of Hospitals Mumbai Maharashtra
India Kingsway Hospitals (Best Multispeciality Hospital in Nagpur) Nagpur Maharashtra
India G.B. Pant Institute of Postgraduate Medical Education & Research New Delhi Delhi
India Nirmal Hospital Surat Gujarat
India Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute Surat Gujarat
Israel Barzilai Medical Center Ashkelon HaDarom
Israel Linn Medical Center Haifa ?eifa
Israel Rambam Health Care Campus Haifa
Israel Rambam Health Care Campus Haifa ?eifa
Israel Edith Wolfson Medical Center Holon HaMerkaz
Israel Hadassah Medical Center Jerusalem Yerushalayim
Israel Meir Medical Center Kfar Saba HaMerkaz
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 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 Clalit Health Services - Sakhnin Community Clinic Sakhnin HaTsafon
Israel Sourasky Medical Center Tel Aviv Tell Abib
Israel Yitzhak Shamir Medical Center Zerifin HaMerkaz
Italy A.O.U.C. Policlinico di Bari Bari Puglia
Italy IRCCS - AOU di Bologna Bologna
Italy Azienda Ospedaliera Mater Domini Catanzaro
Italy Azienda Ospedaliero Universitaria S.Anna Ferrara Emilia-Romagna
Italy Ospedale Santa Maria Goretti Latina
Italy Azienda Ospedaliera di Padova Padova Veneto
Italy A.O.U. Policlinico Paolo Giaccone Palermo Sicilia
Italy Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli Palermo
Italy Azienda Ospedaliera Universitaria Pisana Pisa Toscana
Italy Azienda Ospedaliera Universitaria Pisana Pisa Toscana
Italy Fondazione Policlinico Tor Vergata Rome Lazio
Italy Policlinico Universitario Campus Bio-Medico Rome Roma
Italy IRCCS Policlinico San Donato San Donato Milanese Milano
Italy Presidio Ospedaliero Ospedale Sant'Anna San Fermo della Battaglia Como
Italy Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino
Japan Tokyo-Eki Center-building Clinic Chuo-ku Tokyo
Japan Fukuoka Wajiro Hospital Fukuoka
Japan Rinku General Medical Center Izumisano Osaka
Japan Rakuwakai Otowa Hospital Kyoto
Japan Tokyo Saiseikai Central Hospital Minato-ku Tokyo
Japan Fukuoka Shinmizumaki Hospital Onga-gun Fukuoka
Japan AMC Nishiumeda Clinic Osaka
Japan Shimada Clinic - Osaka Osaka
Japan Uji-Tokushukai Medical Center Uji Kyoto
Korea, Republic of Korea University Ansan Hospital Ansan-si Kyonggi-do
Korea, Republic of Pusan National University Hospital Busan Pusan-Kwangyokshi
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Korea University Anam Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Kyung Hee University Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul-teuk
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Yonsei University-Wonju Severance Christian Hospital Wonju Kang-won-d
Mexico Centro de Investigación Cardiometabólica de Aguascalientes Aguascalientes
Mexico Fundación Cardiovascular de Aguascalientes A.C. Aguascalientes
Mexico Investigacion En Salud Y Metabolismo Sc Chihuahua
Mexico Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Ciudad Madero Tamaulipas
Mexico Centro de Investigación y Gastroenterología Cuauhtémoc
Mexico Instituto de Diabetes, Obesidad y Nutricion Cuernavaca Morelos
Mexico Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. Culiacan Sinaloa
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Mexico Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia Durango
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Mexico CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C Guadalajara Jalisco
Mexico Clinica de Investigacion en Reumatologia y Obesidad S. C. 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 Private Practice - Dr. Francisco Gerardo Padilla Guadalajara Jalisco
Mexico Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco
Mexico Universidad de Guadalajara Guadalajara Jalisco
Mexico Virgen Cardiovascular Research SC Guadalajara Jalisco
Mexico Investigación Médica Sonora, S.C. Hermosillo Sonora
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 CAIMED México Mexico City Distrito Federal
Mexico Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares 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 RM Pharma Specialists Mexico City Distrito Federal
Mexico Cardiolink Clin Trials Monterrey Nuevo León
Mexico Eukarya PharmaSite Monterrey Nuevo León
Mexico Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Mexico Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Mexico IMED Internal Medicine Clin Trials Monterrey Nuevo León
Mexico Unidad biomedica avanzada monterrey Monterrey Nuevo León
Mexico Centro de Estudios Clínicos de Querétaro (CECLIQ) Querétaro
Mexico PanAmerican Clinical Research - Querétaro - Avenida Antea Querétaro
Mexico Unidad Médica para la Salud Integral San Nicolás de los Garza Nuevo León
Mexico Centro de Investigacion Cardiovascular y Metabólica Tijuana Baja California
Mexico Arké SMO S.A de C.V Veracruz
Mexico Instituto Veracruzano en Investigación Clínica S.C. Veracruz
Mexico Consultorio de Medicina Especilizada del Sector Privado Xalapa Veracruz
Mexico Centro de Investigacion Medica de Occidente, S.C. Zapopan Jalisco
Netherlands Ziekenhuisgroep Twente, locatie Almelo Almelo Overijssel
Netherlands Meander Medisch Centrum Amersfoort Utrecht
Netherlands Ziekenhuis Rijnstate Arnhem Gelderland
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Netherlands General Practitioners Research Institute (GPRI) Groningen
Netherlands Martini Ziekenhuis Groningen
Netherlands Spaarne Gasthuis, Haarlem Zuid Haarlem Noord-Holland
Netherlands Elkerliek Ziekenhuis Helmond Noord-Brabant
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Netherlands Ziekenhuis Rivierenland Tiel Gelderland
Poland Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna Bialystok Podlaskie
Poland Osteo Medic sc A. Racewicz, J. Supronik Bialystok Podlaskie
Poland SN ZOZ Lege Artis Poradnia Diabetologiczna Bialystok Podlaskie
Poland Centrum Medyczne NEUROMED Bydgoszcz Kujawsko-pomorskie
Poland INTERCOR Bydgoszcz Kujawsko-pomorskie
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Poland B_serwis Popenda Spolka Jawna Specjalistyczna Przychodnia Lekarska Chorzów Slaskie
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Poland Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie
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Poland CenterMed Lublin NZOZ Lublin Lubelskie
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Poland Gaja Poradnie Lekarskie Maciej Wiza Poznan Wielkopolskie
Poland Nzoz Neuro-Kard Ilkowski i Partnerzy SPL Poznan Wielkopolskie
Poland Centrum Medyczne "Diabetika" Radom Mazowieckie
Poland NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki Ruda Slaska Slaskie
Poland Centralny Szpital Kliniczny MSWiA w Warszawie Warszawa Mazowieckie
Poland NBR Polska Warszawa Mazowiecki
Poland 4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Wroclaw Dolnoslaskie
Poland Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej Wroclaw Dolnoslaskie
Puerto Rico Advanced Clinical Research, LLC Bayamon
Puerto Rico Dorado Medical Complex Dorado
Puerto Rico Puerto Rico Health Institute Dorado
Puerto Rico Manati Center for Clinical Research Manati
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Puerto Rico Research and Cardiovascular Corp. Ponce
Puerto Rico GCM Medical Group, PSC - Hato Rey Site San Juan
Romania SC Minimed SRL Bacau
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Romania Nicodiab Bucharest Bucure?ti
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Romania Institutul de Boli Cardiovasculare Timi?oara Timi?oara Timi?
Romania Cabinet Medical Dr.Geru Timisoara Timi?
Romania Centrul Medical Medicalis Timisoara Timi?
Slovakia MediTask Bratislava
Slovakia JM-Interna s.r.o Dolny Kubin Žilinský Kraj
Slovakia AMBORA s.r.o. Interna ambulancia Martin Žilinský Kraj
Slovakia Funkystuff Nove Zamky Nitriansky Kraj
Slovakia BENIMED s.r.o. Kardiologicka ambulancia Pieštany Trnavský Kraj
Slovakia Diacrin .s.ro. Púchov Trenciansky Kraj
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Spain CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña A Coruña [La Coruña]
Spain Centro Periférico de Especialidades Bola Azul Almeria Almería
Spain Hospital Universitario de La Ribera Alzira Valenciana, Comunitat
Spain Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña]
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona]
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Spain Hospital Universitario San Cecilio Granada
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Spain Complejo Asistencial Universitario de León - Hospital de León León Castilla Y
Spain Hospital Universitario Arnau de Vilanova de Lleida Lleida Lleida [Lérida]
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario Ramón y Cajal Madrid Madrid, Comunidad De
Spain Hospital Universitario Virgen de la Victoria Malaga Andalucía
Spain Hospital Quirón Málaga Málaga
Spain Hospital Universitario Central de Asturias Oviedo Asturias, Principado De
Spain Clínica Juaneda Palma de Mallorca Balears [Baleares]
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón Madrid
Spain Hospital Virgen del Camino Sanlúcar de Barrameda Cádiz
Spain Hospital Universitario Marqués de Valdecilla Santander Cantabria
Spain Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) Sevilla
Spain Hospital Quiron Infanta Luisa Sevilla Andalucía
Spain Vithas Hospital Sevilla Seville Sevilla
Spain Hospital Clinico de Valencia Valencia Valenciana, Comunitat
Spain Hospital General Universitario de Valencia Valencia Valenciana, Comunitat
Spain Hospital Universitario Doctor Peset Valencia València
Spain Hospital Virgen de las Montañas Villamartin Cádiz
Taiwan Mackay Memorial Hospital-Hsinchu Hsinchu City Hsinchu
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist Kaohsiung
Taiwan Taipei Medical University Shuang Ho Hospital New Taipei
Taiwan Far Eastern Memorial Hospital New Taipei City New Taipei
Taiwan Mackay Memorial Hospital -Tamshui Branch New Taipei City
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chi Mei Medical Center Tainan City Tainan
Taiwan Taipei Medical University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei City Taipei
Taiwan Tri-Service General Hospital Taipei City Taipei
Turkey Yuregir Devlet Hastanesi Adana
Turkey Ankara Universitesi Tip Fakultesi Hastanesi Ankara
Turkey Akdeniz Universitesi Hastanesi Antalya
Turkey Aydin Adnan Menderes Universitesi Hastanesi Aydin
Turkey Dokuz Eylul Universitesi Hastanesi Balçova Izmir
Turkey Ege Universitesi Hastanesi Bornova Izmir
Turkey Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre Denizli
Turkey Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep
Turkey TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Kadikoy Istanbul
Turkey Erciyes Universitesi Tip Fakultesi Hastaneleri Kayseri
Turkey Necmettin Erbakan Meram Medical Fac. Konya
Turkey Inönü Üniversitesi Turgut Özal Tip Merkezi Egitim ve Arastirma Hastanesi Malatya
Turkey Mersin University Mersin
Turkey Sisli Etfal Training and Research Hospital Sariyer Istanbul
Turkey Cumhuriyet Universitesi Sivas
Turkey Bursa Yüksek Ihtisas Egitim Ve Arastirma Hastanesi Yildirim Bursa
Turkey Baskent University Dr. Turgut Noyan Research and Training Center Yuregir Adana
United Kingdom Oakenhurst Medical Practice Blackburn Lancashire
United Kingdom Southmead Hospital Bristol Bristol, City Of
United Kingdom University Hospital Coventry & Warwickshire Coventry
United Kingdom Ninewells Hospital and Medical School Dundee Angus
United Kingdom Staploe Medical Centre Ely Cambridgeshire
United Kingdom Fowey River Practice Fowey Cornwall
United Kingdom Hull and East Yorkshire Hospitals NHS Trust Hull Kingston Upon
United Kingdom Ipswich Hospital Ipswich Suffolk
United Kingdom Leicester General Hospital Leicester Leicestershire
United Kingdom Newcastle General Hospital Newcastle upon Tyne
United Kingdom Knowle House Surgery Plymouth Devon
United Kingdom Wickersley Health Centre - Clifton Medical Centre Rotherham
United Kingdom Lister Hospital Stevenage Hertfordshire
United Kingdom Rame Medical Ltd Torpoint Cornwall
United Kingdom The Royal Cornwall Hospital Truro England
United States Albany Medical College, Division of Community Endocrinology Albany New York
United States Albuquerque Neuroscience Inc. Albuquerque New Mexico
United States Smart Cures Clinical Research Anaheim California
United States Kidney & Hypertension Center - Apple Valley Apple Valley California
United States Masters of Clinical Research Augusta Georgia
United States University of Colorado Anschutz Medical Campus Aurora Colorado
United States Pinnacle Clinical Research Austin Texas
United States Texas Diabetes & Endocrinology, P.A. Austin Texas
United States American Health Network of IN, LLC Avon Indiana
United States Maryland Cardiovascular Specialists Baltimore Maryland
United States Heritage Valley Medical Group, Inc. Beaver Pennsylvania
United States CenExel-HRI Berlin New Jersey
United States Billings Clinic Billings Montana
United States The National Diabetes & Obesity Research Institute Biloxi Mississippi
United States Meridian Clinical Research, LLC Binghamton New York
United States Elite Clinical Trials Blackfoot Idaho
United States Excel Medical Clinical Trials Boca Raton Florida
United States Brigham and Women's Hospital Diabetes Program Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Qualmedica Research Bowling Green Kentucky
United States Encore Medical Research of Boynton Beach Boynton Beach Florida
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Hope Clinical Research, Inc. Canoga Park California
United States WR-Clinsearch, LLC Chattanooga Tennessee
United States IMA Clinical Research - Chicago Chicago Illinois
United States Clinical Research of West Florida, Inc. (Clearwater) Clearwater Florida
United States Optum- Southwestern Colorado Springs Colorado
United States Aventiv Research Inc Columbus Ohio
United States John Muir Physician Network Research Center Concord California
United States HOPE Clinical Research & Wellness Conyers Georgia
United States The Corvallis Clinic, P.C. Corvallis Oregon
United States Dallas Diabetes Research Center Dallas Texas
United States Soma Clinical Trials Denison Texas
United States Kidney Associates of Colorado Denver Colorado
United States UniMed Center East Brunswick New Jersey
United States El Paso Medical Research Institute El Paso Texas
United States Centennial Medical Group Elkridge Maryland
United States Neighborhood Healthcare Institute of Health Escondido California
United States Qualmedica Research, LLC Evansville Indiana
United States NECCR PrimaCare Research Fall River Massachusetts
United States Lillestol Research Fargo North Dakota
United States SKY Clinical Research Network Group - Hall Fayette Mississippi
United States Northeast Research Institute (NERI) Fleming Island Florida
United States Healthcare Research Network - Chicago Flossmoor Illinois
United States Diabetes and Thyroid Center of Ft. Worth Fort Worth Texas
United States Valley Institute of Research - Fort Worth Fort Worth Texas
United States HB Clinical Trials - Fountain Valley Fountain Valley California
United States American Health Network of IN, LLC Franklin Indiana
United States Valley Research Fresno California
United States Center for Advanced Research & Education Gainesville Georgia
United States Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC Gilbert Arizona
United States New West Physicians Clinical Research Golden Colorado
United States St. Vincent Hospital d/b/a Prevea Health Green Bay Wisconsin
United States American Health Network of IN, LLC Greenfield Indiana
United States Healthcare Research Network - St. Louis Hazelwood Missouri
United States Indago Research & Health Center, Inc Hialeah Florida
United States East-West Medical Research Institute Honolulu Hawaii
United States Amir A Hassan, MD, PA Houston Texas
United States AngioCardiac Care of Texas, PA Houston Texas
United States Biopharma Informatic, LLC Houston Texas
United States Biopharma Informatic, LLC Houston Texas
United States Houston Methodist Hospital Houston Texas
United States Next Level Urgent Care Houston Texas
United States Rocky Mountain Clinical Research Idaho Falls Idaho
United States Northeast Research Institute - Downtown Office Jacksonville Florida
United States NSC Research Johns Creek Georgia
United States IHS Health Research Kissimmee Florida
United States Scripps Whittier Diabetes Institute La Jolla California
United States Velocity Clinical Research, San Diego La Mesa California
United States First Valley Medical Group Lancaster California
United States DaVita Clinical Research - Las Vegas Las Vegas Nevada
United States Excel Clinical Research, LLC Las Vegas Nevada
United States Palm Research Center Sunset Las Vegas Nevada
United States Palm Research Center Tenaya Las Vegas Nevada
United States Balanced Life Health Care Solutions/SKYCRNG Lawrenceville Georgia
United States Epic Clinical Research Lewisville Texas
United States NJ MedCare & NJ Heart Linden New Jersey
United States KLR Business Group, Inc. dba Arkansas Clinical Research Little Rock Arkansas
United States Long Beach Clinical Trials Long Beach California
United States L-MARC Research Center Louisville Kentucky
United States Texas Institute for Kidney and Endocrine Disorders Lufkin Texas
United States M Health Fairview St. John's Hospital Maplewood Minnesota
United States South Florida Clinical Research Institute Margate Florida
United States Biopharma Informatic, LLC McAllen Texas
United States Texas Institute of Cardiology, PA McKinney Texas
United States Solaris Clinical Research Meridian Idaho
United States Velocity Clinical Research, Boise Meridian Idaho
United States Centricity Research Mesa Arizona
United States Southern Endocrinology Associates Mesquite Texas
United States ActivMed Practices and Research Methuen Massachusetts
United States Felicidad Medical Research Miami Florida
United States Floridian Clinical Research, LLC Miami Lakes Florida
United States Clinical Research Consulting Milford Connecticut
United States Exemplar Research Morgantown West Virginia
United States IMA Clinical Research New York New York
United States NYU Langone Health New York New York
United States Infinity Clinical Research - Norco Norco California
United States Alliance for Multispecialty Research, LLC Norman Oklahoma
United States North Hills Family Medicine/North Hills Medical Research North Richland Hills Texas
United States California Medical Research Associates Northridge California
United States Advanced Research Institute Ogden Utah
United States Olive Branch Family Medical Center Olive Branch Mississippi
United States VA Nebraska-Western Iowa Health Care System Omaha Nebraska
United States Diabetes Associates Medical Group Orange California
United States University of California Irvine Medical Center Orange California
United States Florida Institute For Clinical Research, LLC Orlando Florida
United States FOMAT Medical Research Oxnard California
United States Desert Oasis Healthcare Medical Group Palm Springs California
United States Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Tristar Clinical Investigations Philadelphia Pennsylvania
United States Elite Clinical Studies Phoenix Arizona
United States Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair Pittsburgh Pennsylvania
United States Dream Team Clinical Research Pomona California
United States Peace River Cardiovascular Center Port Charlotte Florida
United States Rancho Cucamonga Clinical Research Rancho Cucamonga California
United States Eastside Research Associates Redmond Washington
United States Advanced Research Institute - Reno Reno Nevada
United States Rainier Clinical Research Center Renton Washington
United States Dominion Medical Associates, Inc. Richmond Virginia
United States National Clinical Research, Inc Richmond Virginia
United States SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi
United States Artemis Institute for Clinical Research Riverside California
United States Rochester Clinical Research, LLC Rochester New York
United States Valiance Clinical Research S. Gate California
United States Northeast Research Institute - St. Augustine Saint Augustine Florida
United States IMA Clinical Research - St. Louis Saint Louis Missouri
United States StudyMetrix Research Saint Peters Missouri
United States IMA Clinical Research - St. Petersburg Saint Petersburg Florida
United States Clinical Trials of Texas, Inc. San Antonio Texas
United States Pinnacle Clinical Research San Antonio Texas
United States VIP Trials San Antonio Texas
United States Acclaim Clinical Research San Diego California
United States Artemis Institute for Clinical Research San Diego California
United States Advanced Research Institute - Sandy Sandy Utah
United States WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia
United States Velocity Clinical Research, Santa Ana Santa Ana California
United States Consano Clinical Research, LLC Shavano Park Texas
United States DaVita Clinical Research - North Houston Shenandoah Texas
United States Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Springfield Illinois
United States Clinvest Research LLC Springfield Missouri
United States Cardiology Associates of Fairfield County, P.C. Stamford Connecticut
United States Clinical Research of West Florida Tampa Florida
United States Valiance Clinical Research Tarzana California
United States Millennium Clinical Trials Thousand Oaks California
United States Northwest Houston Heart Center Tomball Texas
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 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
United States Pima Heart Tucson Arizona
United States Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia
United States Meridian Clinical Research, LLC Vestal New York
United States Impact Research Institute Waco Texas
United States Diablo Clinical Research, Inc. Walnut Creek California
United States Amici Clinical Research LLC Warren New Jersey
United States Chase Medical Research, LLC Waterbury Connecticut
United States Central Washington Health Services Association d/b/a Confluence Health Wenatchee Washington
United States Texas Valley Clinical Research Weslaco Texas
United States Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
United States Metabolic Research Institute, Inc. West Palm Beach Florida
United States Kalo Clinical Research West Valley City Utah
United States Clinical Research of Central Florida Winter Haven Florida
United States North Georgia Clinical Research Woodstock Georgia
United States Soma Clinical Trials Wylie Texas
United States Cardiology Consultants of Philadelphia Yardley Yardley Pennsylvania

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,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Romania,  Slovakia,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events) Time to first occurrence of any component event of composite, all-cause death, nonfatal MI, nonfatal stroke, coronary revascularization, or heart failure events that results in hospitalization or urgent visits. Up to 5 Years
Secondary Time to Onset of Type 2 Diabetes (T2D) Up to 5 Years
Secondary Estimated Glomerular Filtration Rate (eGFR) Slope Up to 5 Years
Secondary Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke) Time to first occurrence of any component event of MACE-3 (CV death, nonfatal MI or nonfatal stroke) Up to 5 Years
Secondary Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score The SF-36 v2 acute, 1-week recall version is a 36-item generic, participant-administered measure designed to assess the following 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role - Emotional, and Mental Health. Each domain is scored individually and further aggregated into 2 health component summary scores, physical component and mental component summary. Scoring of each domain and both summary scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Baseline, 2 Years
Secondary Time to the Occurrence of All-cause Death Up to 5 Years
Secondary Time to First Occurrence of CV Death Up to 5 Years
Secondary Time to First Occurrence of MI Up to 5 Years
Secondary Time to First Occurrence of Stroke Up to 5 Years
Secondary Time to First Occurrence of Coronary Revascularization Up to 5 Years
Secondary Time to First Occurrence Heart Failure (HF) Events Time to first occurrence heart failure (HF) events that result in hospitalization or urgent visits Up to 5 Years
Secondary Time to First Occurrence of Hospitalization for Unstable Angina Up to 5 Years
Secondary Time to first occurrence of Hospitalization or Urgent Visit Time to first occurrence of hospitalization or urgent visit due to atrial fibrillation, or cardioversion or ablation for atrial fibrillation Up to 5 Years
Secondary Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death) Time to first occurrence of any component event of the composite endpoint =40% sustained decline in eGFR, ESRD, or renal death. Up to 5 Years
Secondary Percent Change from Baseline in Body Weight Baseline, 156 Weeks
Secondary Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg) Baseline, 156 Weeks
Secondary Change from Baseline Diastolic Blood Pressure (DBP) (mmHg) Baseline, 156 Weeks
Secondary Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%) Percentage of participants with HbA1c <39 mmol/mol (5.7%) at each time where HbA1c is assessed for participants with a screening HbA1c =39 mmol/mol. Up to 5 Years
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