Overweight and Obesity Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants With Body Mass Index ≥27 kg/m^2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease.
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.
Status | Not yet 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 |
Country | Name | City | State |
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Argentina | Buenos Aires Macula S.A | Buenos Aires | |
Argentina | Cardiología Palermo | Buenos Aires | |
Argentina | Centro Médico Viamonte | Buenos Aires | Ciudad Autónoma De Buenos Aires |
Argentina | CONEXA Investigacion Clinica S.A. | 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 | Consultorio de Investigación Clínica EMO SRL | Ciudad Autonoma de Buenos Aires | Ciudad Autónoma De Buenos Aires |
Argentina | IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas | Ciudad de Buenos Aires | Buenos Aires |
Argentina | Sanatorio Privado Duarte Quirós | Córdoba | |
Argentina | Centro Médico Lebensohn | Junín | Buenos Aires |
Argentina | Hospital Italiano de La Plata | La Plata | Buenos Aires |
Argentina | Polo de Salud Vistalba | Luján de Cuyo | Mendoza |
Argentina | Clínica Privada Independencia | Munro | Buenos Aires |
Argentina | Instituto De Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires |
Argentina | Instituto Médico Río Cuarto | Río Cuarto | Córdoba |
Argentina | Hospital Provincial del Centenario | Rosario | Santa Fe |
Argentina | Instituto de Especialidades de la Salud Rosario | Rosario | Santa Fe |
Argentina | Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica | Rosario | Santa Fe |
Argentina | Centro de Investigaciones Médicas Tucuman | SAN M. DE Tucuman | Tucumán |
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 | Sanatorio San Martin | Venado Tuerto | Santa Fe |
Australia | Nightingale Research | Adelaide | South Australia |
Australia | Optimus Clinical Research | Botany | New South Wales |
Australia | Northern Beaches Clinical Research | Brookvale | New South Wales |
Australia | Emeritus Research | Camberwell | Victoria |
Australia | The AIM Centre / Hunter Diabetes Centre | Merewether | New South Wales |
Austria | Zentrum für klinische Studien Dr Hanusch Gmbh | Vienna | Wien |
Brazil | Consultoria em Controle de Infecção Hospitalar | Belo Horizonte | Minas Gerais |
Brazil | L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192 | Brasília | Distrito Federal |
Brazil | Centro de Endocrinologia Geloneze | Campinas | São Paulo |
Brazil | PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR | Curitiba | Paraná |
Brazil | Centro de Pesquisas Clínicas Dr. Marco Mota | Maceio | Alagoas |
Brazil | CPHOSP Manaus Medicina, Ensino e Pesquisa | Manaus | Amazonas |
Brazil | Hospital Pro-Cardiaco | Rio de Janeiro | |
Brazil | IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | |
Brazil | Ruschel Medicina e Pesquisa Clínica | Rio De Janeiro | |
Brazil | CPQuali Pesquisa Clínica | São Paulo | |
Brazil | Núcleo de Pesquisa Clínica da Rede São Camilo | São Paulo | |
Brazil | Eurolatino Pesquisas Medicas | Uberlandia | Minas Gerais |
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 | Unité de Recherche Clinique du CISSS des Laurentides | St-Jerome | Quebec |
Canada | SMH Cardiology Clinical Trials | Surrey | British Columbia |
Canada | Care Access - Cape Breton | Sydney | Nova Scotia |
Canada | Winnipeg Clinic | Winnipeg | Manitoba |
Czechia | Kardiologicka ambulance | Brandýs nad Labem-Stará Boleslav | Praha-východ |
Czechia | Fakultni Nemocnice u sv. Anny v Brne | Brno | Jihomoravský Kraj |
Czechia | UNIVMED | Brno | Brno-mesto |
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 | MaderMED | Ostrava | Moravskoslezský Kraj |
Czechia | Private Practice - Dr. Miroslav Koliba | Ostrava | Ostrava Mesto |
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 | 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 | Sanos Clinic - Nordjylland | Gandrup | Nordjylland |
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 | Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien | Dresden | Sachsen |
Germany | ZKS Suedbrandenburg | Elsterwerda | Brandenburg |
Germany | InnoDiab Forschung Gmbh | Essen | Nordrhein-Westfalen |
Germany | Unterfrintroper Hausarztzentrum Klinische Forschung | Essen | Nordrhein-Westfalen |
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 | CRS Clinical Research Services 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 |
Hungary | Óbudai Egészségügyi Centrum | Budapest | |
Hungary | Privát Doktor Egészségügyi Zrt | Budapest | |
Hungary | PVN Kutató Kft | Budapest | |
Hungary | Újpesti Egészségügyi Nonprofit Kft | Budapest | |
Hungary | CRU Early Phase Unit | Kistarcsa | Pest |
Hungary | Allergo-Derm Bakos Kft | Szolnok | Jász-Nagykun-Szolnok |
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 | Shrikrishna Hrudayalaya And Critical Care Center | Nagpur | Maharashtra |
India | G.B. Pant Institute of Postgraduate Medical Education & Research | New Delhi | Delhi |
India | Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute | Surat | Gujarat |
Israel | Diabetes Medical Center | Tel Aviv | HaMerkaz |
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 | 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 | 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 | 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 | 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 |
Mexico | Centro de investigación y control metabólico | Monterrey | Nuevo León |
Mexico | Clínica García Flores SC | 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 | |
Mexico | FAICIC S. de R.L. de C.V. | Veracruz | |
Mexico | Instituto Veracruzano en Investigación Clínica S.C. | Veracruz | |
Mexico | Consultorio de Medicina Especilizada del Sector Privado | Xalapa | Veracruz |
Netherlands | Emotional Brain FlevoResearch | Almere | Flevoland |
Netherlands | Huisartsenpraktijk Disha | Den Haag | |
Netherlands | Medisch Centrum Thomsonplein | The Hague | Zuid-Holland |
Netherlands | Dokters van Nederhoven | Zwijndrecht | |
Netherlands | Huisartsenpraktijk Broekman | Zwijndrecht | Zuid-Holland |
Poland | KLIMED Marek Klimkiewicz | Bialystok | Podlaskie |
Poland | Polsko-Amerykanskie Kliniki Serca II Oddzial Kardiologiczny | Bielsko-Biala | Slaskie |
Poland | INTERCOR | Bydgoszcz | Kujawsko-pomorskie |
Poland | NZOZ Centrum Medyczne KERmed | Bydgoszcz | Kujawsko-pomorskie |
Poland | Diab Serwis Popenda Spólka Jawna | Chorzow | Slaskie |
Poland | Polsko-Amerykanskie Kliniki Serca PAKS Malopolskie Centrum Sercowo-Naczyniowe | Chrzanow | Malopolskie |
Poland | Centrum Kliniczno-Badawcze | Elblag | Warminsko-mazurskie |
Poland | NZOZ Diab-Endo-Met | Krakow | Malopolskie |
Poland | Poliklinika Kardiologiczna Serce | Leszno | Wielkopolskie |
Poland | Pro Salus Centrum Medyczne | Lodz | Lódzkie |
Poland | CenterMed Lublin NZOZ | Lublin | Lubelskie |
Poland | Ekamed | Lublin | Lubelskie |
Poland | EndoPractica | Opole | Opolskie |
Poland | Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | Wielkopolskie |
Poland | Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M. Zabówka E. Zabówka | Tarnow | Malopolskie |
Poland | Polsko-Amerykanskie Kliniki Serca | Tychy | Slaskie |
Poland | Balsam Medica | Warsaw | Mazowieckie |
Poland | NZOZ Centurm Medyczne SERAFIN-MED | Zarow | Dolnoslaskie |
Puerto Rico | Advanced Clinical Research, LLC | Bayamón | |
Slovakia | ENDIAMED s.r.o | Dolny Kubin | Žilinský Kraj |
Slovakia | JM-Interna s.r.o | Dolny Kubin | Žilinský Kraj |
Slovakia | NOVUM+ | Kosice | Košický Kraj |
Slovakia | NEDÚ - Národný endokrinologický a diabetologický ústav n.o. | Lubochna | Žilinský Kraj |
Slovakia | IN-DIA | Lucenec | Banskobystrický Kraj |
Slovakia | Sin Azucar | Malacky | Bratislavský Kraj |
Slovakia | AMBORA s.r.o. Interna ambulancia | Martin | Žilinský Kraj |
Slovakia | Fakultná nemocnica Nitra | Nitra | Nitriansky Kraj |
Slovakia | Funkystuff | Nove Zamky | Nitriansky Kraj |
Slovakia | MEDIKALS | Pieštany | Trnavský Kraj |
Slovakia | MUDr. Judita Gondova | Poltar | Banskobystrický Kraj |
Slovakia | ENRIN, s.r.o. | Rimavská Sobota | Banskobystrický Kraj |
Slovakia | Tatratrial s.r.o. | Rožnava | Košický Kraj |
Slovakia | Areteus s.r.o. | Trebisov | Košický Kraj |
Slovakia | MediPrax, s.r.o. | Trstena | Žilinský Kraj |
Slovakia | B-Medical, s.r.o. | Tvrdošín | Žilinský Kraj |
Slovakia | IRIDIA | Vrutky | Žilinský Kraj |
Spain | Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) | Sevilla | |
Turkey | Adana Sehir Egitim ve Arastirma Hastanesi | Adana | |
Turkey | Ankara Bilkent Sehir Hastanesi | Ankara | |
Turkey | T.C. Saglik Bakanligi - Hitit Universitesi Corum Egitim ve Arastirma Hastanesi | Corum | |
Turkey | Eskisehir Osmangazi University | Eskisehir | Eskisehir |
Turkey | Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi | Gaziantep | |
Turkey | Dr. Siyami Ersek Gögüs Kalp Ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi | Istanbul | |
Turkey | Kartal Kosuyolu Yüksek Ihtisas Egitim ve Arastirma Hastanesi | Istanbul | |
Turkey | Istanbul Universitesi Cerrahpasa | Istanbul- Fatih | Istanbul |
Turkey | Erciyes Universitesi Tip Fakultesi Hastaneleri | Kayseri | |
Turkey | Ophthalmology | Kocaeli | |
Turkey | T.C. Saglik Bakanligi - Dumlupinar Universitesi Kutahya Evliya Celebi Egitim ve Arastirma Hastanesi | Kütahya | |
Turkey | Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases | Meram | Konya |
United Kingdom | FutureMeds - Birmingham | Birmingham | |
United Kingdom | Homecroft Surgery | Redruth | Cornwall |
United Kingdom | Rame Medical Ltd | Torpoint | Cornwall |
United States | American Clinical Trials - Acworth | Acworth | Georgia |
United States | Cambridge Medical Trials | Alexandria | Louisiana |
United States | Alaska Heart and Vascular Institute | Anchorage | Alaska |
United States | Kidney & Hypertension Center - Apple Valley | Apple Valley | California |
United States | Atlanta Diabetes Associates | Atlanta | Georgia |
United States | Fides Clinical Research | Atlanta | Georgia |
United States | Southeastern Clinical Research Institute | Augusta | Georgia |
United States | IMA Clinical Research Austin | Austin | Texas |
United States | Maryland Cardiovascular Specialists | Baltimore | Maryland |
United States | AHF Westside | Beverly Hills | California |
United States | Central Research Associates | Birmingham | Alabama |
United States | Excel Medical Clinical Trials | Boca Raton | Florida |
United States | Joslin Diabetes Center | Boston | Massachusetts |
United States | Qualmedica Research | Bowling Green | Kentucky |
United States | Headlands Research - Brownsville | Brownsville | Texas |
United States | Mercury Street Medical Group, PLLC | Butte | Montana |
United States | Hope Clinical Research, Inc. | Canoga Park | California |
United States | Accellacare Trident Cardiology | Charleston | South Carolina |
United States | Alpine Research Organization | Clinton | Utah |
United States | South Texas Clinical Research | Corpus Christi | Texas |
United States | Valley Clinical Trials, Inc. | Covina | California |
United States | Baylor Soltero CV Research Center | Dallas | Texas |
United States | Renal Disease Research Institute | 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 | American Clinical Trials - Douglasville | Douglasville | Georgia |
United States | South Texas Research Institute | Edinburg | Texas |
United States | El Paso Medical Research Institute | El Paso | Texas |
United States | Neighborhood Healthcare Institute of Health | Escondido | California |
United States | The University of Kansas - Clinical Research Center | Fairway | Kansas |
United States | NECCR PrimaCare Research | Fall River | Massachusetts |
United States | Fleming Island Center for Clinical Research | Fleming Island | Florida |
United States | Florida Kidney Physicians - Fort Lauderdale | Fort Lauderdale | Florida |
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 | Center for Advanced Research & Education | Gainesville | Georgia |
United States | St. Vincent Hospital d/b/a Prevea Health | Green Bay | Wisconsin |
United States | Medication Management | Greensboro | North Carolina |
United States | Clinical Investigation Specialists | Gurnee | Illinois |
United States | Amir A Hassan, MD, PA | Houston | Texas |
United States | Aqua Research Institute | Houston | Texas |
United States | Clinical Trial Network | Houston | Texas |
United States | Endocrine Ips, Pllc | Houston | Texas |
United States | Northwest Houston Cardiology - Cypress | Houston | Texas |
United States | Accurate Clinical Research, Inc | Humble | Texas |
United States | Nephrology Consultants | Huntsville | Alabama |
United States | Alliance for Multispecialty Research, LLC | Kansas City | Missouri |
United States | Clinical Investigation Specialists | Kenosha | Wisconsin |
United States | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee |
United States | Scripps Whittier Diabetes Institute | La Jolla | California |
United States | Long Island Cardiovascular Consultants | Lake Success | New York |
United States | DaVita Clinical Research - Las Vegas | Las Vegas | Nevada |
United States | Alliance for Multispecialty Research, LLC | Layton | Utah |
United States | IMA Clinical Research - Lenoir | Lenoir | North Carolina |
United States | Walker Family Care | Little River | South Carolina |
United States | Cardiology and Medicine Clinic | Little Rock | Arkansas |
United States | Accellacare - DuPage | Lombard | Illinois |
United States | L-MARC Research Center | Louisville | Kentucky |
United States | Texas Institute for Kidney and Endocrine Disorders | Lufkin | Texas |
United States | North America Research Institute | Lynwood | California |
United States | East Coast Institute for Research, LLC | Macon | Georgia |
United States | Wellness Clinical Research | McKinney | Texas |
United States | Care Access - Memphis | Memphis | Tennessee |
United States | PRX Research | Mesquite | Texas |
United States | New Age Medical Research Corporation | Miami | Florida |
United States | Inpatient Research Clinic | Miami Lakes | Florida |
United States | Boeson Research MSO | Missoula | Montana |
United States | Alliance for Multispecialty Research, LLC | Mobile | Alabama |
United States | IMA Clinical Research Monroe - Armand | Monroe | Louisiana |
United States | West Clinical Research | Morehead City | North Carolina |
United States | IMA Clinical Research | Morgantown | West Virginia |
United States | Alliance for Multispecialty Research, LLC | New Orleans | Louisiana |
United States | Alliance for Multispecialty Research, LLC | Newton | Kansas |
United States | Alliance for Multispecialty Research, LLC | Norfolk | Virginia |
United States | Valley Clinical Trials, Inc. | Northridge | California |
United States | South Carolina Clinical Research LLC | Orangeburg | South Carolina |
United States | Elixia Central Florida | Orlando | Florida |
United States | Omega Research Orlando | Orlando | Florida |
United States | Helios Clinical Research - SAZ-PDV-026 | Paradise Valley | Arizona |
United States | Alliance for Multispecialty Research, LLC | Park Ridge | Illinois |
United States | California Liver Research Institute | Pasadena | California |
United States | Arizona Cardiovascular Research Center | Phoenix | Arizona |
United States | Phoenix Clinical LLC | Phoenix | Arizona |
United States | Western University of Health Sciences | Pomona | California |
United States | Elixia MKC, LLC | Pontiac | Michigan |
United States | Florida Kidney Physicians - Port Charlotte | Port Charlotte | Florida |
United States | Accellacare - Raleigh | Raleigh | North Carolina |
United States | Eastside Research Associates | Redmond | Washington |
United States | Reid Physician Associates | Richmond | Indiana |
United States | Northwell Health Physician Peconic | Riverhead | New York |
United States | Florida Kidney Physicians - Tampa | Riverview | Florida |
United States | Synexus Clinical Research US, Inc. | Salt Lake City | Utah |
United States | Utah Kidney Research Institute | Salt Lake City | Utah |
United States | Clinical Advancement Center | San Antonio | Texas |
United States | Diagnostics Research Group | San Antonio | Texas |
United States | Endeavor Clinical Trials | San Antonio | Texas |
United States | National Institute of Clinical Research (NICR) - San Antonio - South Laredo Street | San Antonio | Texas |
United States | California Kidney Specialists | San Dimas | California |
United States | Southern California Dermatology, Inc. | Santa Ana | California |
United States | Guthrie Medical Group, P.C. | Sayre | Pennsylvania |
United States | St. Clair Nephrology | Shelby | Michigan |
United States | DaVita Clinical Research - North Houston | Shenandoah | Texas |
United States | Revival Research Institute, LLC | Sherman | Texas |
United States | Circle Clinical Research | Sioux Falls | South Dakota |
United States | Encompass Clinical Research | Spring Valley | California |
United States | Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative | Springfield | Illinois |
United States | Mercy Research - Smith Glynn Callaway | Springfield | Missouri |
United States | Universal Research Group | Tacoma | Washington |
United States | Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research | Tampa | Florida |
United States | Valiance Clinical Research | Tarzana | 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 | 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 | National Institute of Clinical Research (NICR) - High Desert | Victorville | California |
United States | Synexus Clinical Research US - Vista | Vista | California |
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Argentina, Australia, Austria, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, India, Israel, Mexico, Netherlands, Poland, Puerto Rico, Slovakia, Spain, Turkey, United Kingdom,
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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