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Clinical Trial Details

Trial ID: L5115
Source ID: NCT05929079
Associated Drug: Retatrutide
Title: A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Acronym: TRIUMPH-2
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Obesity|Overweight|Obstructive Sleep Apnea
Interventions: DRUG: Retatrutide|DRUG: Placebo
Outcome Measures: Primary: Percent Change from Baseline in Body Weight, Baseline, Week 80|Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset, Baseline, Week 80 | Secondary: 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), 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
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1000
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-11
Completion Date: 2026-05
Results First Posted:
Last Update Posted: 2025-02-28
Locations: Pinnacle Research Group, LLC, Anniston, Alabama, 36207, United States|Cullman Clinical Trials, 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|Quantum Clinical Trials, Miami Beach, Florida, 33140, United States|Clinical Site Partners LLC, dba Flourish Research, Miami, Florida, 33186, 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, 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|Centro Médico Viamonte, Buenos Aires, Ciudad Autónoma De Buenos Aires, C1120AAC, Argentina|Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, 1405, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, C1425AGC, Argentina|Centro de Salud e Investigaciones Médicas, Santa Rosa, La Pampa, 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, Sao 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, Baja California, 21200, Mexico|RM Pharma Specialists, Mexico City, Distrito Federal, 03100, Mexico|Clinica Omega, Mexico City, Distrito Federal, 06700, Mexico|Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, Mexico City, Distrito Federal, 11650, 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|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, 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, 410147, Romania|Geea Medical Easy Diet, Bucharest, București, 010627, Romania|Centrul Medical NutriLife, Bucharest, București, 013764, Romania|Gama Diamed, Mangalia, Constanța, 905500, Romania|Centrul Medical Mediab, Târgu-Mureș, Mureș, 540142, Romania|CMI Dr.Pletea Noemi SRL, Bacău, 600154, Romania|Centro Periférico de Especialidades Bola Azul, Almeria, Almería, 04009, Spain|Hospital Universitario Virgen de la Victoria, Malaga, Andalucía, 29010, Spain|H.R.U Málaga - Hospital Civil, Málaga, Andalucía, 29009, Spain|Complejo Asistencial Universitario de León - Hospital de León, León, Castilla Y 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, Sevilla, 41013, Spain
URL: https://clinicaltrials.gov/show/NCT05929079

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress