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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBK | Other Identifier | Master Protocol Eli Lilly and Company | |
| J1I-MC-GSA2 | Other Identifier | ISA Eli Lilly and Company | |
| 2023-503658-11-00 | Other Identifier | EU Trial Number |
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The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.
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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. |
|
| Retatrutide Dose 3 | 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 | |
| Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset | 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 | |
| Change from Baseline in Systolic Blood Pressure (SBP) |
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Inclusion Criteria:
GSA2 Inclusion Criteria
Exclusion Criteria:
GSA2 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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Cullman Clinical Trials |
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| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight (TRIUMPH-2) | View source |
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Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
a 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 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | 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 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | Baseline, Week 80 |
| Change from Baseline in Fasting Glucose | Baseline, Week 80 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) | AUC is presented as a single average measure of AUC across the study duration. | Baseline through Week 80 |
| Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset | Baseline, Week 80 |
| A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset | A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the component. | Baseline to Week 80 |
| Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset | Baseline to Week 80 |
| Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset | Week 80 |
| Cullman |
| Alabama |
| 35055 |
| United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| Core Healthcare Group | Cerritos | California | 90703 | United States |
| Velocity Clinical Research, Westlake | Los Angeles | California | 90057 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | United States |
| Teradan Clinical Trials, LLC | Brandon | Florida | 33511 | United States |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | United States |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | United States |
| Clinical Site Partners LLC, dba Flourish Research | Miami | Florida | 33186 | United States |
| Quantum Clinical Trials | Miami Beach | Florida | 33140 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Clinical Site Partners, LLC dba Flourish Research | Winter Park | Florida | 32789 | United States |
| NeuroTrials Research Inc | Atlanta | Georgia | 30328 | United States |
| Centricity Research Rincon Pulmonology | Rincon | Georgia | 31406 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Brengle Family Medicine | Indianapolis | Indiana | 46260 | 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 |
| Mid Hudson Medical Research | New Windsor | New York | 12553 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | United States |
| Lillestol Research | Fargo | North Dakota | 58104 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Intrepid Research | Cincinnati | Ohio | 45245 | United States |
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | 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 |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | Buenos Aires F.D. | 1405 | 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 de Salud e Investigaciones Médicas | Santa Rosa | La Pampa Province | 6300 | Argentina |
| Emeritus Research | Botany | New South Wales | 2019 | Australia |
| Woolcock Institute of Medical Research | Macquarie Park | New South Wales | 2113 | Australia |
| The AIM Centre / Hunter Diabetes Centre | Merewether | New South Wales | 2291 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4029 | Australia |
| Core Research Group | Brisbane | Queensland | 4064 | Australia |
| Nightingale Research | Adelaide | South Australia | 5000 | Australia |
| Flinders University | Bedford Park | South Australia | 5042 | 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 |
| Austin Health - Repatriation Hospital | Heidelberg West | Victoria | 3081 | Australia |
| Advara HeartCare Joondalup | Joondalup | Western Australia | 6027 | Australia |
| BR Trials - Ensaios Clinicos e Consultoria | São Paulo | São Paulo | 01236030 | Brazil |
| CPQuali Pesquisa Clínica | São Paulo | 01228-000 | Brazil |
| CEPIC - Centro Paulista de Investigação Clínica | São Paulo | 04266-010 | Brazil |
| All India Institute of Medical Sciences | Raipur | Chhattisgarh | 492099 | India |
| V.S. General Hospital | Ahmedabad | Gujarat | 380006 | India |
| Avron Hospitals | Ahmedabad | Gujarat | 380013 | India |
| Zydus Hospitals & Healthcare Research Pvt.Ltd. | Ahmedabad | Gujarat | 380054 | India |
| Life Care Hospital and Research Centre | Bangalore | Karnataka | 560092 | India |
| Sushruta Multispeciality Hospital & Research Centre | Hubli | Karnataka | 580021 | India |
| Mysore Medical College | Mysore | Karnataka | 570001 | India |
| CARE CHL-Hospitals | Indore | Madhya Pradesh | 452008 | India |
| Sawai Man Singh Medical College Hospital (SMS Hospital) | Jaipur | Rajasthan | 302004 | India |
| Madras Diabetes Research Foundation | Chennai | Tamil Nadu | 600086 | India |
| Christian Medical College Vellore | Vellore | Tamil Nadu | 632004 | India |
| Care Hospitals Hyderabad- Banjara Hills | Hyderabad | Telangana | 500034 | India |
| Diabetes Research Center | Hyderabad | Telangana | 500082 | India |
| Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital | Kolkata | West Bengal | 700020 | India |
| Centro de Investigacion en Artritis y Osteoporosis SC | Mexicali | Estado de Baja California | 21200 | Mexico |
| Diseno y Planeacion en Investigacion Medica | Guadalajara | Jalisco | 44130 | Mexico |
| Private Practice - Dr. Arechavaleta Granell Maria del Rosario | Guadalajara | Jalisco | 44670 | Mexico |
| Unidad de Investigación Clínica y Atención Médica HEPA | Guadalajara | Jalisco | 44670 | Mexico |
| RM Pharma Specialists | Mexico City | Mexico City | 03100 | Mexico |
| Clinica Omega | Mexico City | Mexico City | 06700 | Mexico |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares | Mexico City | Mexico City | 11650 | Mexico |
| Cardiolink Clin Trials | Monterrey | Nuevo León | 64060 | Mexico |
| Unidad biomedica avanzada monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos | Chihuahua City | 31110 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
| Arké SMO S.A de C.V | Veracruz | 91910 | Mexico |
| Diabdana | Oradea | Bihor County | 410147 | Romania |
| Geea Medical Easy Diet | Bucharest | Bucharest | 010627 | Romania |
| Centrul Medical NutriLife | Bucharest | Bucharest | 013764 | Romania |
| Gama Diamed | Mangalia | Constanța County | 905500 | Romania |
| Centrul Medical Mediab | Târgu Mureş | Mureș County | 540142 | Romania |
| CMI Dr.Pletea Noemi SRL | Bacau | 600154 | Romania |
| Centro Periférico de Especialidades Bola Azul | Almería | Almería | 04009 | Spain |
| H.R.U Málaga - Hospital Civil | Málaga | Andalusia | 29009 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Andalusia | 29010 | Spain |
| Complejo Asistencial Universitario de León - Hospital de León | León | Castille and León | 24071 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Vithas Hospital Sevilla | Seville | Sevilla | 41950 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
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