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TRIUMPH-3: A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05882045
Collaborator
(none)
1,800
Enrollment
166
Locations
3
Arms
31.6
Anticipated Duration (Months)
10.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Jan 20, 2026
Anticipated Study Completion Date :
Feb 17, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Retatrutide Dose 1

Participants will receive retatrutide subcutaneously (SC).

Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943

    		•
    Experimental: Retatrutide Dose 2

    Participants will receive retatrutide SC.

    Drug: Retatrutide
    Administered SC
    Other Names:
  • LY3437943

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in Body Weight [Baseline, Week 80]

    Secondary Outcome Measures

    1. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 80]

    2. Change from Baseline in Waist Circumference [Baseline, Week 80]

    3. Percent Change from Baseline in Total Cholesterol [Baseline, Week 80]

    4. Percent Change from Baseline in Triglycerides [Baseline, Week 80]

    5. Change from Baseline in Systolic Blood Pressure (SBP) [Baseline, Week 80]

    6. Change from Baseline in Diastolic Blood Pressure (DBP) [Baseline, Week 80]

    7. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 80]

    8. Percent Change from Baseline in Fasting Insulin [Baseline, Week 80]

    9. Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score [Baseline, Week 80]

    10. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Phoenix Medical Clinic Phoenix Arizona United States 85020
    2 Valley Clinical Trials, Inc. Covina California United States 91723
    3 Valley Research Fresno California United States 93720
    4 Collaborative Neuroscience Research, LLC Los Alamitos California United States 90720
    5 Velocity Clinical Research, Westlake Los Angeles California United States 90057
    6 Valley Clinical Trials, Inc. Northridge California United States 91325
    7 Velocity Clinical Research, Panorama City Panorama City California United States 91402
    8 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    9 Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Jacksonville Florida United States 32256
    10 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
    11 Progressive Medical Research Port Orange Florida United States 32127
    12 Charter Research - Winter Park Winter Park Florida United States 32792
    13 Pacific Diabetes & Endocrine Center Honolulu Hawaii United States 96813
    14 Elite Clinical Trials Blackfoot Idaho United States 83221
    15 Humphreys Diabetes Center Boise Idaho United States 83702
    16 Northwestern University Chicago Illinois United States 60611
    17 Great Lakes Clinical Trials - Gurnee Gurnee Illinois United States 60031
    18 Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Springfield Illinois United States 62711
    19 Brengle Family Medicine Indianapolis Indiana United States 46260
    20 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    21 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
    22 MedVadis Research Corporation Waltham Massachusetts United States 02451
    23 StudyMetrix Research Saint Peters Missouri United States 63303
    24 Las Vegas Medical Research Las Vegas Nevada United States 89113
    25 Palm Research Center Tenaya Las Vegas Nevada United States 89128
    26 Amici Clinical Research LLC Warren New Jersey United States 07059
    27 Weill Cornell Medical College New York New York United States 10021
    28 Rochester Clinical Research, Inc. Rochester New York United States 14609
    29 Carteret Medical Group Morehead City North Carolina United States 28557
    30 Cleveland Clinic Cleveland Ohio United States 44195
    31 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    32 University of Pittsburgh Medical Center Magee-Womens Hospital Pittsburgh Pennsylvania United States 15213
    33 UPMC Montefiore University Hospital Pittsburgh Pennsylvania United States 15213
    34 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    35 Trial Management Associates Myrtle Beach South Carolina United States 29572
    36 Tribe Clinical Research - Spartanburg Spartanburg South Carolina United States 29301
    37 Texas Diabetes & Endocrinology, P.A. Austin Texas United States 78731
    38 Pinnacle Clinical Research Austin Texas United States 78757
    39 Southern Endocrinology Associates Mesquite Texas United States 75149
    40 Texas Diabetes & Endocrinology, P.A. Round Rock Texas United States 78681
    41 Sleep Therapy Research Center San Antonio Texas United States 78229
    42 Consano Clinical Research, LLC Shavano Park Texas United States 78231
    43 Advanced Research Institute Ogden Utah United States 84405
    44 Rainier Clinical Research Center Renton Washington United States 98057
    45 CEDIC Caba Buenos Aires Argentina C1060ABN
    46 Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aire Buenos Aires Argentina 1405
    47 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires Argentina 1056
    48 IDIM - Instituto de Investigaciones Metabólicas Ciudad de Buenos Aires Buenos Aires Argentina C1012AAR
    49 MICA - Medicina e Investigación Cardiometabólica Del Viso Buenos Aires Argentina 1669
    50 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
    51 DIM Clínica Privada Ramos Mejía Buenos Aires Argentina B1704ETD
    52 Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires Argentina B2800DGH
    53 Stat Research S.A. Buenos Aires Ciudad Aut Argentina C1023AAB
    54 Centro Médico Viamonte Buenos Aires Ciudad Aut Argentina C1120AAC
    55 Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1179AAB
    56 Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire Argentina C1425AGC
    57 Centro Medico Privado CEMAIC Capital Córdoba Argentina X5008HHW
    58 Centro Medico Privado San Vicente Diabetes Cordoba Córdoba Argentina 5006
    59 Centro de Salud e Investigaciones Médicas Santa Rosa La Pampa Argentina 6300
    60 CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Mendoza Argentina 5501
    61 Centro de Investigaciones Clínicas Baigorria Granadero Baigorria Santa Fe Argentina 2152
    62 INECO Neurociencias Oroño Rosario Santa Fe Argentina 2000
    63 Instituto de Investigaciones Clinicas Rosario Rosario Santa Fe Argentina 2000
    64 Sanatorio San Martin Venado Tuerto Santa Fe Argentina 2600
    65 Sanatorio Norte Santiago del Estero Santiago D Argentina 4200
    66 Centro de Investigaciones Médicas Tucuman San Miguel De Tucumán Tucumán Argentina T4000AXL
    67 Fundación Respirar Buenos Aires Argentina C1426ABP
    68 Instituto Médico DAMIC Córdoba Argentina 5003DCE
    69 Centro de Investigaciones Clinicas del Litoral Santa Fe Argentina S3000FWO
    70 Emeritus Research Botany New South Wales Australia 2019
    71 The AIM Centre / Hunter Diabetes Centre Merewether New South Wales Australia 2291
    72 University of Sydney - Charles Perkins Centre Sydney New South Wales Australia 2006
    73 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
    74 Core Research Group Brisbane Queensland Australia 4064
    75 CDH Research Institute Maroochydore Queensland Australia 4558
    76 Logan Hospital Meadowbrook Queensland Australia 4131
    77 Fusion Clinical Research Adelaide South Australia Australia 5000
    78 Nightingale Research Adelaide South Australia Australia 5000
    79 Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia Australia 5046
    80 Box Hill Hospital Box Hill Victoria Australia 3128
    81 Emeritus Research Camberwell Victoria Australia 3124
    82 Barwon Health Geelong Victoria Australia 3220
    83 Austin Health - Repatriation Hospital Heidelberg West Victoria Australia 3081
    84 Advara HeartCare Joondalup Joondalup Western Au Australia 6027
    85 BC Diabetes Office Vancouver British Columbia Canada V5Y 3W2
    86 Discovery Clinical Services Victoria British Columbia Canada V8T 5G4
    87 Centricity Research - New Minas New Minas Nova Scotia Canada B4N 3R7
    88 Joanne F. Liutkus Medicine Professional Corporation Cambridge Ontario Canada N3H 4L5
    89 LMC Clinical Research Inc. (Thornhill) Concord Ontario Canada L4K 4M2
    90 Dr. Steven V. Zizzo Medicine Professional Corporation Hamilton Ontario Canada L8J 0B6
    91 Milestone Research Inc. London Ontario Canada N5W 6A2
    92 Centricity Research Oshawa Oshawa Ontario Canada L1J 2K9
    93 Kawartha Cardiology Clinical Trials Peterborough Ontario Canada K9J 0B2
    94 Private Practice - Dr. Pierre Bonin Sudbury Ontario Canada P3A 1Y8
    95 Manna Research Toronto Toronto Ontario Canada M9W 4L6
    96 Ecogene-21 - Cmas Chicoutimi Quebec Canada G7H 0S7
    97 Ecogene-21 Chicoutimi Quebec Canada G7H 7K9
    98 Clinique de médecine Urbaine du Quartier Latin Montreal Quebec Canada H2L 4E9
    99 Centre de Medecine Metabolique de Lanaudiere (CMML) Terrebonne Quebec Canada J6X 4P7
    100 Syneos Health Quebec Canada G1P0A2
    101 Arina Trial Research Orosháza Békés Hungary 5900
    102 Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged Csongrád Hungary 6725
    103 Regia Med Kft Szekesfehervar Fejér Hungary 8000
    104 Medifarma 98 Kft Nyiregyhaza Nyíregyháza Hungary 4400
    105 Szent Lázár Megyei Kórház Salgótarján Nógrád Hungary 3100
    106 Óbudai Egészségügyi Centrum - Kaposvár Site Kaposvár Somogy Hungary 7400
    107 DRC Gyógyszervizsgáló Központ Balatonfüred Veszprém Hungary 8230
    108 Zala Megyei Szent Rafael Kórház Zalaegerszeg Zala Hungary 8900
    109 Óbudai Egészségügyi Centrum Budapest Hungary 1036
    110 ClinDiab Kft. Budapest Hungary 1089
    111 TRANTOR'99 Bt. Anyagcsere Centrum Budapest Hungary 1213
    112 Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház Debrecen Hungary 4031
    113 Óbudai Egészségügyi Centrum - Zalaegerszeg Zalaegerszeg Hungary 8900
    114 Centro de Investigacion Cardiovascular y Metabólica Tijuana Baja California Mexico 22500
    115 RM Pharma Specialists Mexico City Distrito Federal Mexico 03100
    116 Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City Distrito Federal Mexico 11650
    117 Centro Multidisciplinario de Diabetes de Pachuca Pachuca Hidalgo Mexico 42084
    118 Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco Mexico 44670
    119 Centro de Investigacion Medica de Occidente, S.C. Zapopan Jalisco Mexico 44260
    120 IMED Internal Medicine Clin Trials Monterrey Nuevo León Mexico 64060
    121 Clínica García Flores SC Monterrey Nuevo León Mexico 64610
    122 Eukarya PharmaSite Monterrey Nuevo León Mexico 64718
    123 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
    124 Medical Care and Research SA de CV Merida Yucatán Mexico 97070
    125 EME RED Hospitalaria Mérida Yucatán Mexico 97000
    126 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
    127 Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia Durango Mexico 34000
    128 Centro de Atención e Investigación Cardiovascular del Potosí San Luis Potosí Mexico 78200
    129 FAICIC S. de R.L. de C.V. Veracruz Mexico 91900
    130 NBR Polska Warszawa Mazowieckie Poland 00-710
    131 RST Rehabilitacja Bialy Kosciol Małopolskie Poland 32-089
    132 Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET Krakow Małopolskie Poland 31-261
    133 KLIMED Marek Klimkiewicz Bialystok Podlaskie Poland 15-704
    134 Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie Poland 80-546
    135 Ambulatorium Sp. z o.o. Elbląg Warmińsko-mazurskie Poland 82-300
    136 Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz Łódzkie Poland 90338
    137 Centrum Medyczne Pratia Katowice Katowice Śląskie Poland 40-081
    138 NZOZ Salvia CM Katowice Śląskie Poland 40-772
    139 Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze Śląskie Poland 41-800
    140 Clinical Research Management Group Inc. - Hospital San Cristobal Ponce Puerto Rico 00716
    141 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716
    142 Latin Clinical Trial Center San Juan Puerto Rico 00909
    143 Nemocnica s poliklinikou Lucenec Lucenec Banskobystrický Kraj Slovakia 984 01
    144 Metabol KLINIK Bratislava Bratislavský Kraj Slovakia 811 08
    145 MediVet s.r.o. Malacky Bratislavský Kraj Slovakia 901 01
    146 Human Care s.r.o. Kosice Košický Kraj Slovakia 04001
    147 Tatratrial s.r.o. Rožňava Košický Kraj Slovakia 04801
    148 Areteus s.r.o. Trebisov Košický Kraj Slovakia 075 01
    149 MEDI-DIA s.r.o. Sabinov Prešovský Kraj Slovakia 083 01
    150 ProDia s.r.o. Povazska Bystrica Trenčiansky Kraj Slovakia 017 01
    151 MediTask Bratislava Slovakia 831 03
    152 Diab - Int Bytca Žilinský Kraj Slovakia 014 01
    153 Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Ferrol A Coruña [La Coruña] Spain 15405
    154 Hu Reina Sofia Cordoba Andalucía Spain 14004
    155 'Hospital Virgen de la Victoria Malaga Andalucía Spain 29010
    156 Hospital Quiron Infanta Luisa Sevilla Andalucía Spain 41010
    157 Hospital Universitari Son Espases Palma Balears [Baleares] Spain 07120
    158 Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona] Spain 08035
    159 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
    160 Hospital Virgen del Camino Sanlúcar de Barrameda Cádiz Spain 11540
    161 Hospital Virgen de las Montañas Villamartin Cádiz Spain 11650
    162 Hospital Universitario Arnau de Vilanova de Lleida Lleida Lleida [Lérida] Spain 25198
    163 Vithas Hospital Sevilla Seville Sevilla Spain 41950
    164 Hospital Universitario de La Ribera Alzira Valenciana, Comunitat Spain 46600
    165 Hospital General Universitario Gregorio Marañon Madrid Spain 28009
    166 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05882045
    Other Study ID Numbers:
    • 18582
    • J1I-MC-GZBM
    • 2023-503659-88-00
    First Posted:
    May 31, 2023
    Last Update Posted:
    May 31, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Obesity

    Study Results

    No Results Posted as of May 31, 2023