A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
- Conditions
- ObesityCardiovascular Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT05882045
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1800
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 1 Retatrutide Participants will receive retatrutide subcutaneously (SC). Retatrutide Dose 2 Retatrutide Participants will receive retatrutide SC. Placebo Placebo Participants will receive placebo.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 80
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Mass Index (BMI) Baseline, Week 80 Change from Baseline in Waist Circumference Baseline, Week 80 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC) Baseline to Week 80 AUC is presented as a single average measure of AUC across the study duration.
Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 80 Percent Change from Baseline in Fasting Insulin Baseline, Week 80 Percent Change from Baseline in Total Cholesterol Baseline, Week 80 Percent Change from Baseline in Triglycerides Baseline, Week 80 Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 80 Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score Baseline, Week 80
Trial Locations
- Locations (165)
Óbudai Egészségügyi Centrum - Zalaegerszeg
🇭🇺Zalaegerszeg, Hungary
Fundación Respirar
🇦🇷Buenos Aires, Argentina
DRC Gyógyszervizsgáló Központ
🇭🇺Balatonfüred, Veszprém, Hungary
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Zala, Hungary
Óbudai Egészségügyi Centrum
🇭🇺Budapest, Hungary
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
ClinDiab Kft.
🇭🇺Budapest, Hungary
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Texas Diabetes & Endocrinology, P.A.
🇺🇸Round Rock, Texas, United States
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Los Alamitos, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Van Nuys, California, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Great Lakes Clinical Trials - Gurnee
🇺🇸Gurnee, Illinois, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Brengle Family Medicine
🇺🇸Indianapolis, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
IMA Clinical Research Warren
🇺🇸Warren, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Valley Research
🇺🇸Fresno, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Humphreys Diabetes Center
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
UPMC Montefiore University Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Tribe Clinical Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Pinnacle Clinical Research
🇺🇸Austin, Texas, United States
South Texas Clinical Research
🇺🇸Corpus Christi, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Sleep Therapy Research Center
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
CEDIC
🇦🇷Caba, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
IDIM - Instituto de Investigaciones Metabólicas
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
MICA - Medicina e Investigación Cardiometabólica
🇦🇷Del Viso, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
DIM Clínica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Stat Research S.A.
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Privado CEMAIC
🇦🇷Capital, Córdoba, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
🇦🇷Godoy Cruz, Mendoza, Argentina
Canberra Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Centro Medico Privado San Vicente Diabetes
🇦🇷Cordoba, Córdoba, Argentina
Centro de Salud e Investigaciones Médicas
🇦🇷Santa Rosa, La Pampa, Argentina
Centro de Investigaciones Clínicas Baigorria
🇦🇷Granadero Baigorria, Santa Fe, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Northern Beaches Clinical Research
🇦🇺Brookvale, New South Wales, Australia
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico DAMIC
🇦🇷Córdoba, Argentina
Centro de Investigaciones Clinicas del Litoral
🇦🇷Santa Fe, Argentina
Sanatorio Norte
🇦🇷Santiago del Estero, Argentina
Sanatorio San Martin
🇦🇷Venado Tuerto, Santa Fe, Argentina
Camden Hospital
🇦🇺Camden, New South Wales, Australia
The AIM Centre / Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
University of Sydney - Charles Perkins Centre
🇦🇺Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Core Research Group
🇦🇺Brisbane, Queensland, Australia
CDH Research Institute
🇦🇺Maroochydore, Queensland, Australia
Logan Hospital
🇦🇺Meadowbrook, Queensland, Australia
Fusion Clinical Research
🇦🇺Adelaide, South Australia, Australia
Nightingale Research
🇦🇺Adelaide, South Australia, Australia
Southern Adelaide Diabetes & Endocrine Services
🇦🇺Oaklands Park, South Australia, Australia
TRANTOR'99 Bt. Anyagcsere Centrum
🇭🇺Budapest, Hungary
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Barwon Health
🇦🇺Geelong, Victoria, Australia
Austin Health - Repatriation Hospital
🇦🇺Heidelberg West, Victoria, Australia
One Clinical Research
🇦🇺Nedlands, Western Australia, Australia
BC Diabetes Office
🇨🇦Vancouver, British Columbia, Canada
Discovery Clinical Services
🇨🇦Victoria, British Columbia, Canada
Joanne F. Liutkus Medicine Professional Corporation
🇨🇦Cambridge, Ontario, Canada
LMC Clinical Research Inc. (Thornhill)
🇨🇦Concord, Ontario, Canada
Dr. Steven V. Zizzo Research Professional Corporation
🇨🇦Hamilton, Ontario, Canada
Milestone Research Inc.
🇨🇦London, Ontario, Canada
North York Diagnostic and Cardiac Centre
🇨🇦North York, Ontario, Canada
Centricity Research Oshawa
🇨🇦Oshawa, Ontario, Canada
Debreceni Egyetem Klinikai Központ
🇭🇺Debrecen, Hungary
Kawartha Cardiology Clinical Trials
🇨🇦Peterborough, Ontario, Canada
Manna Research Toronto
🇨🇦Toronto, Ontario, Canada
Ecogene-21 - Cmas
🇨🇦Chicoutimi, Quebec, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Clinique de médecine Urbaine du Quartier Latin
🇨🇦Montreal, Quebec, Canada
CardioVasc HR Inc
🇨🇦Saint-Jean-sur-Richelieu, Quebec, Canada
Centre de Medecine Metabolique de Lanaudiere (CMML)
🇨🇦Terrebonne, Quebec, Canada
C.I.C. Mauricie inc.
🇨🇦Trois-Rivières, Quebec, Canada
Syneos Health
🇨🇦Quebec, Canada
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Regia Med Kft
🇭🇺Szekesfehervar, Fejér, Hungary
Medifarma 98 Kft
🇭🇺Nyiregyhaza, Nyíregyháza, Hungary
Szent Lázár Megyei Kórház
🇭🇺Salgótarján, Nógrád, Hungary
Óbudai Egészségügyi Centrum - Kaposvár Site
🇭🇺Kaposvár, Somogy, Hungary
Centro de Investigacion Cardiovascular y Metabólica
🇲🇽Tijuana, Baja California, Mexico
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
Centro Multidisciplinario de Diabetes de Pachuca
🇲🇽Pachuca, Hidalgo, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica de Occidente, S.C.
🇲🇽Zapopan, Jalisco, Mexico
IMED Internal Medicine Clin Trials
🇲🇽Monterrey, Nuevo León, Mexico
Clínica García Flores SC
🇲🇽Monterrey, Nuevo León, Mexico
Eukarya PharmaSite
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Medical Care and Research SA de CV
🇲🇽Merida, Yucatán, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí
🇲🇽San Luis Potosí, Mexico
EME RED Hospitalaria
🇲🇽Mérida, Yucatán, Mexico
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
🇵🇱Krakow, Małopolskie, Poland
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
🇲🇽Chihuahua, Mexico
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
🇲🇽Durango, Mexico
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
NBR Polska
🇵🇱Warszawa, Mazowieckie, Poland
Nemocnica s poliklinikou Lucenec
🇸🇰Lucenec, Banskobystrický Kraj, Slovakia
KLIMED Marek Klimkiewicz
🇵🇱Bialystok, Podlaskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Ambulatorium Sp. z o.o.
🇵🇱Elbląg, Warmińsko-mazurskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Łódzkie, Poland
Clinical Research Management Group Inc
🇵🇷Ponce, Puerto Rico
MediVet s.r.o.
🇸🇰Malacky, Bratislavský Kraj, Slovakia
Human Care s.r.o.
🇸🇰Kosice, Košický Kraj, Slovakia
Tatratrial s.r.o.
🇸🇰Rožňava, Košický Kraj, Slovakia
Areteus s.r.o.
🇸🇰Trebisov, Košický Kraj, Slovakia
MEDI-DIA s.r.o.
🇸🇰Sabinov, Prešovský Kraj, Slovakia
MediTask
🇸🇰Bratislava, Slovakia
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Śląskie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
🇵🇱Zabrze, Śląskie, Poland
Diab - Int
🇸🇰Bytca, Žilinský Kraj, Slovakia
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
🇪🇸Ferrol, A Coruña [La Coruña], Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Andalucía, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
NZOZ Salvia CM
🇵🇱Katowice, Śląskie, Poland
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
Metabol KLINIK
🇸🇰Bratislava, Bratislavský Kraj, Slovakia
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
Hospital Universitari Son Espases
🇪🇸Palma, Balears [Baleares], Spain
Hospital Virgen de las Montañas
🇪🇸Villamartin, Cádiz, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Arnau de Vilanova de Lleida
🇪🇸Lleida, Lleida [Lérida], Spain
Hospital Virgen del Camino
🇪🇸Sanlúcar de Barrameda, Cádiz, Spain
Vithas Hospital Sevilla
🇪🇸Seville, Sevilla, Spain
Hospital Universitario de La Ribera
🇪🇸Alzira, Valenciana, Comunitat, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain