The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383390
• Other study ID #: 18584
• Secondary ID: J1I-MC-GZBO2023-
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: February 2029

Study information

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity
• Overweight
• Overweight and Obesity

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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Mexico,  Netherlands,  Poland,  Puerto Rico,  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)