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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBM | Other Identifier | Eli Lilly and Company | |
| 2023-503659-88-00 | Other Identifier | EU Trial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide Dose 1 | Experimental | Participants will receive retatrutide subcutaneously (SC). |
|
| Retatrutide Dose 2 | Experimental | Participants will receive retatrutide SC. |
|
| Placebo | Placebo Comparator | Participants will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retatrutide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 80 | |
| Change from Baseline in Waist Circumference | Baseline, Week 80 | |
| Percent Change from Baseline in Total Cholesterol |
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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:
Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Phoenix Medical Clinic | Phoenix | Arizona | 85020 | United States | ||
| Valley Clinical Trials, Inc. |
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| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Baseline, Week 80 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 80 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 80 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 80 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 80 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 80 |
| Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score | Baseline, Week 80 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC) | AUC is presented as a single average measure of AUC across the study duration. | Baseline to Week 80 |
| Covina |
| California |
| 91723 |
| United States |
| Neuro-Pain Medical Center | Fresno | California | 93710 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | United States |
| Velocity Clinical Research, Westlake | Los Angeles | California | 90057 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Velocity Clinical Research, Panorama City | Van Nuys | California | 91405 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Charter Research - Winter Park | Orlando | Florida | 32803 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Pacific Diabetes & Endocrine Center | Honolulu | Hawaii | 96817 | United States |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | United States |
| Humphreys Diabetes Center | Boise | Idaho | 83702 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Great Lakes Clinical Trials - Gurnee | Gurnee | Illinois | 60031 | United States |
| Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative | Springfield | Illinois | 62711 | United States |
| Brengle Family Medicine | Indianapolis | Indiana | 46260 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Cotton O'Neil Diabetes & Endocrinology | Topeka | Kansas | 66606 | United States |
| MedVadis Research Corporation | Waltham | Massachusetts | 02451 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Las Vegas Medical Research | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| UPMC Montefiore University Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| Trial Management Associates | Myrtle Beach | South Carolina | 29572 | United States |
| Tribe Clinical Research - Spartanburg | Spartanburg | South Carolina | 29301 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | United States |
| Pinnacle Clinical Research | Austin | Texas | 78757 | United States |
| South Texas Clinical Research | Corpus Christi | Texas | 78404 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Texas Diabetes & Endocrinology, P.A. | Round Rock | Texas | 78681 | United States |
| Sleep Therapy Research Center | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| CEDIC | CABA | Buenos Aires | C1060ABN | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1056 | Argentina |
| IDIM - Instituto de Investigaciones Metabólicas | Ciudad de Buenos Aires | Buenos Aires | C1012AAR | Argentina |
| MICA - Medicina e Investigación Cardiometabólica | Del Viso | Buenos Aires | 1669 | Argentina |
| Instituto de Investigaciones Clínicas Mar del Plata | Mar del Plata | Buenos Aires | 7600 | Argentina |
| DIM Clínica Privada | Ramos Mejía | Buenos Aires | B1704ETD | Argentina |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | Buenos Aires F.D. | 1405 | Argentina |
| Stat Research S.A. | Buenos Aires | Buenos Aires F.D. | C1023AAB | Argentina |
| Investigaciones Medicas Imoba Srl | Buenos Aires | Buenos Aires F.D. | C1056ABH | Argentina |
| Centro Médico Viamonte | Buenos Aires | Buenos Aires F.D. | C1120AAC | Argentina |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Buenos Aires | Buenos Aires F.D. | C1425AGC | Argentina |
| Centro Medico Privado CEMAIC | Capital | Córdoba Province | X5008HHW | Argentina |
| Centro Medico Privado San Vicente Diabetes | Córdoba | Córdoba Province | 5006 | Argentina |
| Centro de Salud e Investigaciones Médicas | Santa Rosa | La Pampa Province | 6300 | Argentina |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes | Godoy Cruz | Mendoza Province | 5501 | Argentina |
| Centro de Investigaciones Clínicas Baigorria | Granadero Baigorria | Santa Fe Province | 2152 | Argentina |
| INECO Neurociencias Oroño | Rosario | Santa Fe Province | 2000 | Argentina |
| Instituto de Investigaciones Clinicas Rosario | Rosario | Santa Fe Province | 2000 | Argentina |
| Sanatorio San Martin | Venado Tuerto | Santa Fe Province | 2600 | Argentina |
| Centro de Investigaciones Médicas Tucuman | SAN M. de Tucuman | Tucumán Province | T4000AXL | Argentina |
| Fundación Respirar | Buenos Aires | C1426ABP | Argentina |
| Instituto Médico DAMIC | Córdoba | 5003DCE | Argentina |
| Centro de Investigaciones Clinicas del Litoral | Santa Fe | S3000FWO | Argentina |
| Sanatorio Norte | Santiago del Estero | 4200 | Argentina |
| Canberra Hospital | Canberra | Australian Capital Territory | 2605 | Australia |
| Emeritus Research | Botany | New South Wales | 2019 | Australia |
| Northern Beaches Clinical Research | Brookvale | New South Wales | 2100 | Australia |
| Camden Hospital | Camden | New South Wales | 2570 | Australia |
| The AIM Centre / Hunter Diabetes Centre | Merewether | New South Wales | 2291 | Australia |
| University of Sydney - Charles Perkins Centre | Sydney | New South Wales | 2006 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4029 | Australia |
| Core Research Group | Brisbane | Queensland | 4064 | Australia |
| CDH Research Institute | Maroochydore | Queensland | 4558 | Australia |
| Logan Hospital | Meadowbrook | Queensland | 4131 | Australia |
| Fusion Clinical Research | Adelaide | South Australia | 5000 | Australia |
| Nightingale Research | Adelaide | South Australia | 5000 | Australia |
| Southern Adelaide Diabetes & Endocrine Services | Mount Gambier | South Australia | 5290 | Australia |
| Southern Adelaide Diabetes & Endocrine Services | Oaklands Park | South Australia | 5046 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| Barwon Health | Geelong | Victoria | 3220 | Australia |
| Austin Health - Repatriation Hospital | Heidelberg West | Victoria | 3081 | Australia |
| One Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| BC Diabetes Office | Vancouver | British Columbia | V5Y 3W2 | Canada |
| Discovery Clinical Services | Victoria | British Columbia | V8T 5G4 | Canada |
| Joanne F. Liutkus Medicine Professional Corporation | Cambridge | Ontario | N3H 4L5 | Canada |
| LMC Clinical Research Inc. (Thornhill) | Concord | Ontario | L4K 4M2 | Canada |
| Dr. Steven V. Zizzo Research Professional Corporation | Hamilton | Ontario | L8J 0B6 | Canada |
| Milestone Research Inc. | London | Ontario | N5W 6A2 | Canada |
| North York Diagnostic and Cardiac Centre | North York | Ontario | M6B 3H7 | Canada |
| Centricity Research Oshawa | Oshawa | Ontario | L1J 2K9 | Canada |
| Kawartha Cardiology Clinical Trials | Peterborough | Ontario | K9J 0B2 | Canada |
| Manna Research Toronto | Toronto | Ontario | M9W 4L6 | Canada |
| Ecogene-21 - Cmas | Chicoutimi | Quebec | G7H 0S7 | Canada |
| Ecogene-21 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Clinique de médecine Urbaine du Quartier Latin | Montreal | Quebec | H2L 4E9 | Canada |
| CardioVasc HR Inc | Saint-Jean-sur-Richelieu | Quebec | J3A 1J2 | Canada |
| Centre de Medecine Metabolique de Lanaudiere (CMML) | Terrebonne | Quebec | J6X 4P7 | Canada |
| C.I.C. Mauricie inc. | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Syneos Health | Québec | G1P0A2 | Canada |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Szeged | Csongrád megye | 6725 | Hungary |
| Regia Med Kft | Székesfehérvár | Fejér | 8000 | Hungary |
| Medifarma 98 Kft | Nyíregyháza | Nyíregyháza | 4400 | Hungary |
| Szent Lázár Megyei Kórház | Salgótarján | Nógrád megye | 3100 | Hungary |
| Óbudai Egészségügyi Centrum - Kaposvár Site | Kaposvár | Somogy County | 7400 | Hungary |
| DRC Gyógyszervizsgáló Központ | Balatonfüred | Veszprém megye | 8230 | Hungary |
| Zala Megyei Szent Rafael Kórház | Zalaegerszeg | Zala County | 8900 | Hungary |
| Óbudai Egészségügyi Centrum | Budapest | 1036 | Hungary |
| ClinDiab Kft. | Budapest | 1089 | Hungary |
| TRANTOR'99 Bt. Anyagcsere Centrum | Budapest | 1213 | Hungary |
| Debreceni Egyetem Klinikai Központ | Debrecen | 4031 | Hungary |
| Óbudai Egészségügyi Centrum - Zalaegerszeg | Zalaegerszeg | 8900 | Hungary |
| Centro de Investigacion Cardiovascular y Metabólica | Tijuana | Estado de Baja California | 22500 | Mexico |
| Centro Multidisciplinario de Diabetes de Pachuca | Pachuca | Hidalgo | 42084 | Mexico |
| Unidad de Investigación Clínica y Atención Médica HEPA | Guadalajara | Jalisco | 44670 | Mexico |
| Centro de Investigacion Medica de Occidente, S.C. | Zapopan | Jalisco | 44260 | Mexico |
| RM Pharma Specialists | Mexico City | Mexico City | 03100 | Mexico |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares | Mexico City | Mexico City | 11650 | Mexico |
| IMED Internal Medicine Clin Trials | Monterrey | Nuevo León | 64060 | Mexico |
| Clínica García Flores SC | Monterrey | Nuevo León | 64610 | Mexico |
| Eukarya PharmaSite | Monterrey | Nuevo León | 64718 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 66460 | Mexico |
| EME RED Hospitalaria | Mérida | Yucatán | 97000 | Mexico |
| Medical Care and Research SA de CV | Mérida | Yucatán | 97070 | Mexico |
| Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos | Chihuahua City | 31110 | Mexico |
| Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia | Durango | 34000 | Mexico |
| Centro de Atención e Investigación Cardiovascular del Potosí | San Luis Potosí City | 78200 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
| Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| NBR Polska | Warsaw | Masovian Voivodeship | 00-710 | Poland |
| KLIMED Marek Klimkiewicz | Bialystok | Podlaskie Voivodeship | 15-704 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | Silesian Voivodeship | 40-081 | Poland |
| NZOZ Salvia CM | Katowice | Silesian Voivodeship | 40-772 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 SUM | Zabrze | Silesian Voivodeship | 41-800 | Poland |
| Ambulatorium Sp. z o.o. | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódź Voivodeship | 90338 | Poland |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| Clinical Research Management Group Inc | Ponce | 00717 | Puerto Rico |
| Latin Clinical Trial Center | San Juan | 00909 | Puerto Rico |
| Nemocnica s poliklinikou Lucenec | Lučenec | Banská Bystrica Region | 984 01 | Slovakia |
| Metabol KLINIK | Bratislava | Bratislava Region | 811 08 | Slovakia |
| MediVet s.r.o. | Malacky | Bratislava Region | 901 01 | Slovakia |
| Human Care s.r.o. | Košice | Košice Region | 04001 | Slovakia |
| Tatratrial s.r.o. | Rožňava | Košice Region | 04801 | Slovakia |
| Areteus s.r.o. | Trebišov | Košice Region | 075 01 | Slovakia |
| MEDI-DIA s.r.o. | Sabinov | Presov | 083 01 | Slovakia |
| MediTask | Bratislava | 831 03 | Slovakia |
| Diab - Int | Bytča | Žilina Region | 014 01 | Slovakia |
| Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval | Ferrol | A Coruña [La Coruña] | 15405 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Andalusia | 14004 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Hospital Quiron Infanta Luisa | Seville | Andalusia | 41010 | Spain |
| Hospital Universitari Son Espases | Palma | Balears [Baleares] | 07120 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Virgen del Camino | Sanlúcar de Barrameda | Cádiz | 11540 | Spain |
| Hospital Virgen de las Montañas | Villamartín | Cádiz | 11650 | Spain |
| Hospital Universitario Arnau de Vilanova de Lleida | Lleida | Lleida [Lérida] | 25198 | Spain |
| Vithas Hospital Sevilla | Seville | Sevilla | 41950 | Spain |
| Hospital Universitario de La Ribera | Alzira | Valenciana, Comunitat | 46600 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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