Clinical trial NCT05882045: A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
Official title: A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Cardiovascular Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
* Have established cardiovascular (CV) disease with at least 1 of the following:

  * prior myocardial infarction
  * prior ischemic or hemorrhagic stroke, or
  * symptomatic peripheral arterial disease
* Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria:

* Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment of obesity.
* Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
* Have Type 1 diabetes.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 80
Secondary outcomes:
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 80
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 80
measure: Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
timeFrame: Baseline, Week 80
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)
timeFrame: Baseline to Week 80
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Covina
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Van Nuys
country: United States
facility: Velocity Clinical Research, Panorama City
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Boise
country: United States
facility: Humphreys Diabetes Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials - Gurnee
state: Illinois
city: Springfield
country: United States
facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Brengle Family Medicine
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Warren
country: United States
facility: IMA Clinical Research Warren
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Montefiore University Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Spartanburg
country: United States
facility: Tribe Clinical Research - Spartanburg
state: South Carolina
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy Research Center
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: IDIM - Instituto de Investigaciones Metabólicas
state: Buenos Aires
city: Del Viso
country: Argentina
facility: MICA - Medicina e Investigación Cardiometabólica
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Stat Research S.A.
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC
state: Córdoba
city: Cordoba
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
state: Córdoba
city: Santa Rosa
country: Argentina
facility: Centro de Salud e Investigaciones Médicas
state: La Pampa
city: Godoy Cruz
country: Argentina
facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
state: Mendoza
city: Granadero Baigorria
country: Argentina
facility: Centro de Investigaciones Clínicas Baigorria
state: Santa Fe
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Venado Tuerto
country: Argentina
facility: Sanatorio San Martin
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Córdoba
country: Argentina
facility: Instituto Médico DAMIC
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral
city: Santiago del Estero
country: Argentina
facility: Sanatorio Norte
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Camden
country: Australia
facility: Camden Hospital
state: New South Wales
city: Merewether
country: Australia
facility: The AIM Centre / Hunter Diabetes Centre
state: New South Wales
city: Sydney
country: Australia
facility: University of Sydney - Charles Perkins Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Core Research Group
state: Queensland
city: Maroochydore
country: Australia
facility: CDH Research Institute
state: Queensland
city: Meadowbrook
country: Australia
facility: Logan Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Fusion Clinical Research
state: South Australia
city: Adelaide
country: Australia
facility: Nightingale Research
state: South Australia
city: Mount Gambier
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Oaklands Park
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: Vancouver
country: Canada
facility: BC Diabetes Office
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services
state: British Columbia
city: Cambridge
country: Canada
facility: Joanne F. Liutkus Medicine Professional Corporation
state: Ontario
city: Concord
country: Canada
facility: LMC Clinical Research Inc. (Thornhill)
state: Ontario
city: Hamilton
country: Canada
facility: Dr. Steven V. Zizzo Research Professional Corporation
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc.
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Oshawa
country: Canada
facility: Centricity Research Oshawa
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology Clinical Trials
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Toronto
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21 - Cmas
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Montreal
country: Canada
facility: Clinique de médecine Urbaine du Quartier Latin
state: Quebec
city: Saint-Jean-sur-Richelieu
country: Canada
facility: CardioVasc HR Inc
state: Quebec
city: Terrebonne
country: Canada
facility: Centre de Medecine Metabolique de Lanaudiere (CMML)
state: Quebec
city: Trois-Rivières
country: Canada
facility: C.I.C. Mauricie inc.
state: Quebec
city: Quebec
country: Canada
facility: Syneos Health
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Szekesfehervar
country: Hungary
facility: Regia Med Kft
state: Fejér
city: Nyiregyhaza
country: Hungary
facility: Medifarma 98 Kft
state: Nyíregyháza
city: Salgótarján
country: Hungary
facility: Szent Lázár Megyei Kórház
state: Nógrád
city: Kaposvár
country: Hungary
facility: Óbudai Egészségügyi Centrum - Kaposvár Site
state: Somogy
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ
state: Veszprém
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház
state: Zala
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Budapest
country: Hungary
facility: ClinDiab Kft.
city: Budapest
country: Hungary
facility: TRANTOR'99 Bt. Anyagcsere Centrum
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Zalaegerszeg
country: Hungary
facility: Óbudai Egészségügyi Centrum - Zalaegerszeg
city: Tijuana
country: Mexico
facility: Centro de Investigacion Cardiovascular y Metabólica
state: Baja California
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Centro Multidisciplinario de Diabetes de Pachuca
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA
state: Jalisco
city: Zapopan
country: Mexico
facility: Centro de Investigacion Medica de Occidente, S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: IMED Internal Medicine Clin Trials
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Mérida
country: Mexico
facility: EME RED Hospitalaria
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
city: Durango
country: Mexico
facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
city: San Luis Potosí
country: Mexico
facility: Centro de Atención e Investigación Cardiovascular del Potosí
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Warszawa
country: Poland
facility: NBR Polska
state: Mazowieckie
city: Krakow
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
state: Małopolskie
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Elbląg
country: Poland
facility: Ambulatorium Sp. z o.o.
state: Warmińsko-mazurskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Śląskie
city: Katowice
country: Poland
facility: NZOZ Salvia CM
state: Śląskie
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
state: Śląskie
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: Ponce
country: Puerto Rico
facility: Clinical Research Management Group Inc
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Lucenec
country: Slovakia
facility: Nemocnica s poliklinikou Lucenec
state: Banskobystrický Kraj
city: Bratislava
country: Slovakia
facility: Metabol KLINIK
state: Bratislavský Kraj
city: Malacky
country: Slovakia
facility: MediVet s.r.o.
state: Bratislavský Kraj
city: Kosice
country: Slovakia
facility: Human Care s.r.o.
state: Košický Kraj
city: Rožňava
country: Slovakia
facility: Tatratrial s.r.o.
state: Košický Kraj
city: Trebisov
country: Slovakia
facility: Areteus s.r.o.
state: Košický Kraj
city: Sabinov
country: Slovakia
facility: MEDI-DIA s.r.o.
state: Prešovský Kraj
city: Bratislava
country: Slovakia
facility: MediTask
city: Bytca
country: Slovakia
facility: Diab - Int
state: Žilinský Kraj
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
state: A Coruña [La Coruña]
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
state: Andalucía
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Balears [Baleares]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Sanlúcar de Barrameda
country: Spain
facility: Hospital Virgen del Camino
state: Cádiz
city: Villamartin
country: Spain
facility: Hospital Virgen de las Montañas
state: Cádiz
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova de Lleida
state: Lleida [Lérida]
city: Seville
country: Spain
facility: Vithas Hospital Sevilla
state: Sevilla
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Valenciana, Comunitat
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: