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Clinical Trial Details

Trial ID: L3380
Source ID: NCT05929066
Associated Drug: Retatrutide
Title: A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
Acronym: TRIUMPH-1
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Obesity|Overweight|Osteoarthritis, Knee|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 the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset, Baseline, Week 80|Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset, Baseline, Week 80|Percent Change from Baseline in Body Weight to, Baseline, Week 104 | 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|Percent Change form Baseline in Fasting Insulin, Baseline, Week 80|Change from Baseline in HbA1c, Baseline, Week 80|Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score, 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|Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset, Baseline, Week 80|Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset, Baseline, Week 80|Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset, Baseline, Week 80|Percent Change from Baseline in AHI for GSA1 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 GSA1 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 components., Baseline to Week 80|Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset, Baseline to Week 80|Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset, Week 80
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-07-10
Completion Date: 2026-05
Results First Posted:
Last Update Posted: 2025-02-27
Locations: Central Phoenix Medical Clinic, Phoenix, Arizona, 85020, United States|Arizona Research Center, Phoenix, Arizona, 85053, United States|Medical Investigations, Little Rock, Arkansas, 72211, United States|Neuro-Pain Medical Center, Fresno, California, 93710, United States|Valley Research, Fresno, California, 93720, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06519, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Teradan Clinical Trials, LLC, Brandon, Florida, 33511, United States|Suncoast Research Group, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Clinical Neuroscience Solutions, Orlando, Florida, 32801, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|NeuroTrials Research Inc, Atlanta, Georgia, 30328, United States|North Georgia Clinical Research, Woodstock, Georgia, 30189, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Northwestern University, Chicago, Illinois, 60611, 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|Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, 66606, United States|MedVadis Research Corporation, Waltham, Massachusetts, 02451, United States|Great Lakes Research Group, Inc., Bay City, Michigan, 48706, United States|StudyMetrix Research, Saint Peters, Missouri, 63303, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States|Rochester Clinical Research, LLC, Rochester, New York, 14609, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Trial Management Associates - Wilmington - Floral Parkway, Wilmington, North Carolina, 28403, United States|Lillestol Research, Fargo, North Dakota, 58104, United States|Altoona Center For Clinical Research, Duncansville, Pennsylvania, 16635, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|Tribe Clinical Research - Spartanburg, Spartanburg, South Carolina, 29301, United States|Vanderbilt Health One Hundred Oaks, Nashville, Tennessee, 37204, United States|FutureSearch Trials of Neurology, Austin, Texas, 78731, United States|Juno Research, Houston, Texas, 77040, United States|Advanced Research Institute, Ogden, Utah, 84405, United States|Northwest Clinical Research Center, Bellevue, Washington, 98007, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|Emeritus Research, Botany, New South Wales, 2019, Australia|The AIM Centre / Hunter Diabetes Centre, Merewether, New South Wales, 2291, Australia|Logan Hospital, Meadowbrook, Queensland, 4131, Australia|Fusion Clinical Research, Adelaide, South Australia, 5000, Australia|Nightingale Research, Adelaide, South Aust, 5000, Australia|Emeritus Research, Camberwell, Victoria, 3124, Australia|Barwon Health, Geelong, Victoria, 3220, Australia|One Clinical Research, Nedlands, Western Australia, 6009, Australia|CPCLIN, Sao Paulo, São Paulo, 01228-200, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|Dr. Steven V. Zizzo Medicine Professional Corporation, Hamilton, Ontario, L8J 0B6, Canada|Wharton Medical Clinic, Hamilton, Ontario, L8L 5G8, Canada|Your Research Network, Niagara Falls, Ontario, L2H 1H5, Canada|Bluewater Clinical Research Group Inc., Sarnia, Ontario, N7T 4X3, Canada|Canadian Phase Onward, Toronto, Ontario, M3J 0K2, Canada|Centre de Recherche Clinique de Laval, Laval, Quebec, H7T 2P5, Canada|Clinique de médecine Urbaine du Quartier Latin, Montreal, Quebec, H2L 4E9, Canada|C.I.C. Mauricie inc., Trois-Rivières, Quebec, G8T 7A1, Canada|Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, Csongrád, 6725, Hungary|Regia Med Kft, Szekesfehervar, Fejér, 8000, Hungary|Medifarma 98 Kft, Nyiregyhaza, Nyíregyháza, 4400, Hungary|DRC Gyógyszervizsgáló Központ, Balatonfüred, Veszprém, 8230, Hungary|Óbudai Egészségügyi Centrum, Budapest, 1036, Hungary|ClinDiab Kft., Budapest, 1089, Hungary|Debreceni Egyetem Klinikai Központ, Debrecen, 4031, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 4032, Hungary|Endolife Speciality Hospitals, Guntur, Andhra Pradesh, 522001, India|Avron Hospitals, Ahmedabad, Gujarat, 380013, India|Surat Institute of Digestive Sciences Hospitals, Surat, Gujarat, 395002, India|Karnataka Institute of Medical Sciences, Hubli, Karnataka, 580021, India|Indian Institute of Diabetes, Thiruvananthapuram, Kerala, 695031, India|Jothydev's Diabetes and Research Center, Trivandrum, Kerala, 695032, India|Wockhardt Hospital - Mumbai Central, Mumbai, Maharashtra, 400011, India|Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, 411004, India|Chellaram Diabetes Institute, Pune, Maharashtra, 411021, India|Lifepoint Multispeciality Hospital, Pune, Maharashtra, 411057, India|All India Institute of Medical Sciences, Bhubaneswar, Odisha, 751019, India|Eternal Heart Care Center and Research Institute, Jaipur, Rajasthan, 302020, India|Christian Medical College Vellore, Vellore, Tamil Nadu, 632004, India|ILS Hospitals, Kolkata, West Benga, 700064, 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|Diseno y Planeacion en Investigacion Medica, Guadalajara, Jalisco, 44130, Mexico|Clinica de Investigacion en Reumatologia y Obesidad S. C., Guadalajara, Jalisco, 44650, 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|Instituto de Diabetes, Obesidad y Nutricion, Cuernavaca, Morelos, 62250, Mexico|Unidad biomedica avanzada monterrey, Monterrey, Nuevo León, 64460, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo León, 66460, Mexico|EME RED Hospitalaria, Mérida, Yucatán, 97000, Mexico|Kohler and Milstein Research S.A. de C.V., Mérida, Yucatán, 97070, Mexico|Centro de Atención e Investigación Clínica, Aguascalientes, 20119, Mexico|Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos, Chihuahua, 31110, Mexico|Arké SMO S.A de C.V, Veracruz, 91910, Mexico|INTERCOR, Bydgoszcz, Kujawsko-pomorskie, 85-605, Poland|CenterMed Lublin NZOZ, Lublin, Lubelskie, 20-044, Poland|Gabinety TERPA, Lublin, Lubelskie, 20-333, Poland|MICS Centrum Medyczne Warszawa, Warszawa, Mazowieckie, 00-874, Poland|Private Practice - Dr. Robert Witek, Tarnów, Małopolskie, 33-100, Poland|Uniwersytecki Szpital Kliniczny w Białymstoku, Białystok, Podlaskie, 15-276, Poland|Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Pomorskie, 80-546, Poland|Centrum Kliniczno-Badawcze, Elblag, Warmińsko-mazurskie, 82-300, Poland|Ambulatorium Sp. z o.o., Elbląg, Warmińsko-mazurskie, 82-300, Poland|Centrum Zdrowia Metabolicznego Pawel Bogdanski, Poznań, Wielkopolskie, 60-589, Poland|NZOZ Salvia CM, Katowice, Śląskie, 40-772, Poland|Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci, Kielce, Świętokrzyskie, 25-355, Poland|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico|Diabdana, Oradea, Bihor, 410147, Romania|C.M.D.T.A. Neomed, Brasov, Brașov, 500283, Romania|Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului, Bucharest, București, 011053, Romania|Gama Diamed, Mangalia, Constanța, 905500, Romania|Cabinet Medical Dr.Geru, Timisoara, Timiș, 300288, Romania|SC Minimed SRL, Bacău, 600274, Romania|Diamed Obesity, Galați, 800291, Romania|Centrul Medical Consultmed, Iași, 700547, Romania|Clinica Korall, Satu Mare, 440055, Romania|Policlinica Astra Sibiu, Sibiu, 550371, Romania|CHUAC-Complejo Hospitalario Universitario A Coruña, A Coruña, A Coruña [La Coruña], 15006, Spain|Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval, Ferrol, A Coruña [La Coruña], 15405, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], 08035, Spain|Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, 39008, Spain|Hospital General Universitario de Valencia, Valencia, Valenciana, Comunitat, 46014, Spain|Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE), Sevilla, 41003, Spain|Rowden Surgery, Chippenham, England, SN15 2SB, United Kingdom|Layton Medical Centre, Blackpool, Lancashire, FY3 7EN, United Kingdom|Leicester General Hospital, Leicester, Leicestershire, LE5 4PW, United Kingdom|Panthera Biopartners - North London, Enfield, London, City Of, EN3 4GS, United Kingdom|Glasgow Royal Infirmary, Glasgow, Scotland, G31 2ER, United Kingdom|Heartlands Hospital, Birmingham, B9 5SS, United Kingdom|Aintree University Hospital NHS Foundation Trust, Liverpool, L9 7AL, United Kingdom|St Clare Medical Centre, Penzance, TR18 3DX, United Kingdom|Panthera Biopartners - Sheffield, Sheffield, S2 5FX, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05929066

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress