The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
Кой може да участва
Inclusion Criteria:
* Participants may be without type 2 diabetes (T2D), or with T2D if 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) (0.030 mg/mg)
* eGFR \<60 mL/min/1.73 m\^2 and UACR \>100 mg/g (0.100 mg/mg), or
* eGFR \<75 mL/min/1.73 m\^2 and UACR \>300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)
* A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2)
Exclusion Criteria:
Diabetes related:
* Participants have Type 1 Diabetes or any 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 (5.000 mg/mg) 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
Интервенции
Retatrutide
DRUG
Placebo
DRUG
Места на провеждане
745
Argentina (59)
CONEXA Investigacion Clinica S.A.
Buenos Aires
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires
Buenos Aires Macula S.A
Buenos Aires
Cicemo Srl
Buenos Aires
Cardiología Palermo
Buenos Aires
Stat Research S.A.
Buenos Aires
Investigaciones Medicas Imoba Srl
Buenos Aires
CIPREC
Buenos Aires
CIPREC
Buenos Aires
Centro Médico Viamonte
Buenos Aires
Mautalen Salud e Investigación
Buenos Aires
CEMEDIC
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Fundación Respirar
Buenos Aires
Glenny Corp. S.A.
Buenos Aires
CEMEDIAB
C.a.b.a.
CEDIC
CABA
Instituto Médico Especializado (IME)
CABA
Centro Medico Privado CEMAIC
Capital
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires
Centro Diabetológico Dr. Waitman
Córdoba
Instituto de Investigaciones Clínicas Córdoba
Córdoba
Sanatorio Privado Duarte Quirós
Córdoba
Centro Médico Colón
Córdoba
Centro Medico Privado San Vicente Diabetes
Córdoba
CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani
Córdoba
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria
CMD-Centro Médico y Diagnóstico por Imágenes
Junín
Hospital Italiano de La Plata
La Plata
CIMeL
Lanus
Polo de Salud Vistalba
Lujan de Cuyo
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata
Instituto De Investigaciones Clinicas Quilmes
Quilmes
DIM Clínica Privada
Ramos Mejía
Instituto Médico Río Cuarto
Río Cuarto
Fundacion Estudios Clinicos
Rosario
INECO Neurociencias Oroño
Rosario
Instituto Especialidades de la Salud Rosario
Rosario
Instituto Médico Catamarca IMEC
Rosario
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario
Instituto de Investigaciones Clinicas Rosario
Rosario
Laboratorio de Hemostasia y Trombosis
Rosario
Hospital Provincial del Centenario
Rosario
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman
Corporación Médica San Martín
San Martin
Centro Modelo de Cardiología
San Miguel de Tucumán
Investigaciones Clínicas Tucumán
San Miguel de Tucumán
Go Centro Medico San Nicolás
San Nicolás
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares
Santa Fe
Centro de Investigaciones Clinicas del Litoral
Santa Fe
Centro de Salud e Investigaciones Médicas
Santa Rosa
Sanatorio Norte
Santiago del Estero
Centro de Investigaciones Medicas Temperley
Temperley
Sanatorio San Martin
Venado Tuerto
CEREHA
Villa Domínico
Instituto de Investigaciones Clinicas Zarate
Zárate
Австралия (16)
Nightingale Research
Adelaide
Emeritus Research
Botany
Box Hill Hospital
Box Hill
Royal Brisbane and Women's Hospital
Brisbane
Northern Beaches Clinical Research
Brookvale
Emeritus Research
Camberwell
Canberra Hospital
Garran
Barwon Health
Geelong
Austin Health - Repatriation Hospital
Heidelberg West
Logan Hospital
Meadowbrook
The Alfred Hospital
Melbourne
The AIM Centre / Hunter Diabetes Centre
Merewether
Fiona Stanley Hospital
Murdoch
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park
Royal North Shore Hospital
St Leonards
University of Sydney - Charles Perkins Centre
Sydney
Австрия (12)
Krankenhaus St. Josef Braunau
Braunau am Inn
VIVIT
Feldkirch
Medizinische Universität Graz
Graz
Medizinische Universitaet Innsbruck
Innsbruck
Konventhospital der Barmherzigen Brüder Linz
Linz
Cardio Metabolic Centre
Mattersburg
Private Practice - Dr. Evelyn Fliesser-Gorzer
Sankt Stefan ob Stainz
Klinik Landstraße
Vienna
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Klinik Hietzing
Vienna
Imed19-privat
Vienna
Белгия (21)
AZORG Campus Aalst-Moorselbaan
Aalst
ANIMA Research
Alken
Imelda General Hospital
Bonheiden
Algemeen Ziekenhuis klina
Brasschaat
Centre Hospitalier Universitaire Brugmann
Brussels
Université Libre de Bruxelles - Hôpital Erasme
Brussels
UZ Brussel
Brussels
Cliniques universitaires Saint-Luc
Brussels
Antwerp University Hospital
Edegem
UZ Gent
Ghent
Jessa Ziekenhuis
Hasselt
Jan Yperman Ziekenhuis
Ieper
Kormont
Kluisbergen
AZ Groeninge Campus Kennedylaan
Kortrijk
UZ Leuven
Leuven
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège
ZNA Jan Palfijn
Merksem
Az Damiaan vzw
Ostend
Artsenpraktijk OHIO
Oudenaarde
Private Practice - Dr. De Watertoren
Tielt
Private Practice - Dr. Tim Decraecke (Zwalm)
Zwalm
Бразилия (48)
Centro de Pesquisa Clinica do Coracao
Aracaju
Hospital Universitário João de Barros Barreto
Belém
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
Freire Pesquisa Clínica
Belo Horizonte
AngioKormann Blumenau
Blumenau
L2IP - Instituto de Pesquisas Clínicas
Brasília
Chronos Pesquisa Clínica
Brasília
Instituto de Pesquisa clinica de Campinas
Campinas
Centro de Pesquisa Sao Lucas
Campinas
Centro de Endocrinologia Geloneze
Campinas
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul
Cline Research Center
Curitiba
Quanta Diagnóstico e Terapia
Curitiba
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba
Instituto Pro Renal Brasil
Curitiba
Centro de Diabetes Curitiba
Curitiba
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza
Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE
Fortaleza
Private Practice - Dr.Miguel N. Hissa
Fortaleza
Universidade Federal de Goias
Goiânia
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió
CPHOSP Manaus Medicina, Ensino e Pesquisa
Manaus
Centro de Pesquisa Clínica de Marília - CPCLIM
Marília
Instituto Méderi de Pesquisa e Saúde
Passo Fundo
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro
Hospital Pro-Cardiaco
Rio de Janeiro
Clinica Senhor do Bonfim CSB - Salvador
Salvador
Pesquisare Saude
Santo André
Praxis Pesquisa Medica
Santo André
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos
Instituto de Pesquisa Clinica
São Paulo
CPQuali Pesquisa Clínica
São Paulo
CPCLIN
São Paulo
BR Trials - Ensaios Clinicos e Consultoria
São Paulo
BP - A Beneficencia Portuguesa de São Paulo
São Paulo
Hospital Alemao Oswaldo Cruz
São Paulo
IBCC - Núcleo de Pesquisa e Ensino
São Paulo
CEPIC - Centro Paulista de Investigação Clínica
São Paulo
Hospital das Clinicas FMUSP
São Paulo
Incor - Instituto do Coracao
São Paulo
Instituto de Molestias Cardiovasculares de Tatui
Tatuí
Eurolatino Pesquisas Medicas
Uberlândia
CEDOES
Vitória
Integral Pesquisa e Ensino
Votuporanga
Канада (22)
C-health Research
Calgary
Ecogene-21
Chicoutimi
Med Trust Research
Courtice
C-health
Edmonton
St. Joseph's Health Care
London
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London
Western Centre for Public Health and Family Medicine
London
G A Research Associates
Moncton
North York Diagnostic and Cardiac Centre
North York
Lakeridge Health
Oshawa
Alpha Recherche Clinique
Québec
Unité de Recherche Clinique du CISSS des Laurentides
Saint-Jérôme
Ocean West Research Clinic
Surrey
SMH Cardiology Clinical Trials
Surrey
Care Access - Cape Breton
Sydney
Care Access - Thunder Bay - Barton Street
Thunder Bay
Corcare
Toronto
Toronto General Hospital
Toronto
Clinical Research Solutions - Kitchener
Waterloo
Winchester District Memorial Hospital
Winchester
Seven Oaks General Hospital
Winnipeg
Winnipeg Clinic
Winnipeg
Чехия (32)
MEDICUS SERVICES s.r.o., kardiologicka ambulance
Brandýs nad Labem
Fakultni Nemocnice u sv. Anny v Brne
Brno
UNIVMED
Brno
Fakultni Nemocnice u sv. Anny v Brne
Brno
Vojenská Nemocnice Brno
Brno
Nemocnice Cesky Krumlov
Český Krumlov
Kardio Chlumec
Chlumec nad Cidlinou
Diahaza s.r.o.
Holešov
Kardioma
Kolín
Kardiologicka ambulance
Litovel
EDUMED - Náchod
Náchod
Agentura Science Pro
Olomouc
Diabetologicke centrum s.r.o.
Olomouc
PreventaMed
Olomouc
Private Practice - Dr. Miroslav Koliba
Ostrava
Donmed s.r.o.
Ostrava
Kardiologicka a Angiologicka Ambulance
Ostrava - Dubina
MUDr. Jana Parkanyiova
Prague
Synexus Czech
Prague
MEDICON
Prague
Fakultni Thomayerova nemocnice
Prague
Nefrologie
Prague
Poliklinika Lípa Centrum
Prague
FLEDIP - Na dlouhem lanu
Prague
Centrum Kardiovaskularni Mediciny
Prague
Diabetologie a endokrinologie, J.Venerová
Prague
ResTrial s.r.o.
Prague
MUDr. Barbora Diepoltova
Praha 9 - Klanovice
Diakom, s.r.o. - Přeštice
Přeštice
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Trutnov
Clinical Trials Service s.r.o.
Uherské Hradiště
Cardio Research, s.r.o
Zlín
Дания (6)
Sygehus Sønderjylland i Aabenraa
Aabenraa
Aarhus Universitetshospital, Skejby
Aarhus
Sanos Clinic - Nordjylland
Gandrup
Herlev and Gentofte Hospital
Herlev
Sanos Clinic
Herlev
Sanos Clinic - Syddanmark
Vejle
Франция (16)
Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume
Bordeaux University Hospital - Pellegrin
Bordeaux
Chu Gabriel Montpied
Clermont-Ferrand
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Chu Grenoble Alpes
La Tronche
Centre Hospitalier Louis Pasteur
Le Coudray
CHU Montpellier Lapeyronie Hospital
Montpellier
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Nantes
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice
Pitie Salpetriere University Hospital
Paris
Groupe hospitalier Paris saint Joseph
Paris
Hôpital Européen Georges Pompidou
Paris
CHU Bordeaux Haut-Leveque
Pessac
CHU Rangueil
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours
Polyclinique Vauban
Valenciennes
Германия (25)
Kerckhoff-Klinik
Bad Nauheim
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
БГ
EN