Clinical Trial Details

Trial ID: L0195
Source ID: NCT04166773
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
Acronym: SYNERGY-NASH
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic Steatohepatitis
Interventions: Drug: Tirzepatide|Drug: Placebo
Outcome Measures: Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology|Percentage of Participants with ???1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology|Percentage of Participants with ???1 Point Increase in Fibrosis Stage on Liver Histology|Percentage of Participants that Achieve a ???2 Point Decrease in NAFLD (non-alcoholic fatty liver disease) Activity Score (NAS) on Liver Histology, with ???1 Point Reduction in at Least 2 NAS Components|Mean Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)|Mean Change from Baseline in Body Weight
Sponsor/Collaborators: Eli Lilly and Company
Gender: All
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 196
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: November 19, 2019
Completion Date: December 15, 2023
Results First Posted: --
Last Update Posted: March 10, 2022
Locations: University of Alabama at Birmingham Medical Center, Birmingham, Alabama, United States|Synexus- Chandler, Chandler, Arizona, United States|Fresno Clinical Research Center, Fresno, California, United States|Velocity Clinical Research, Huntington Park, Huntington Park, California, United States|Velocity Clinical Research, Huntington Park, Huntington Park, California, United States|NAFLD Research Center, UCSD Altman Clinical and Translational Research Institute (ACTRI), La Jolla, California, United States|Catalina Research Institute, LLC, Montclair, California, United States|Diabetes Medical Center of California, Northridge, California, United States|Velocity Clinical Research, Huntington Park, Panorama City, California, United States|Alliance Clinical Research, LLC, Poway, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|Velocity Clinical Research, Huntington Park, Santa Ana, California, United States|Excel Medical Clinical Trials, Boca Raton, Florida, United States|Clinical Research of South Florida, Coral Gables, Florida, United States|Research Centers of America, LLC-Hollywood, Hollywood, Florida, United States|East Coast Institute for Research at The Jones Center, Jacksonville, Florida, United States|I.H.S. Health, LLC, Kissimmee, Florida, United States|Meridien Research, Maitland, Florida, United States|Panax Clinical Research, Miami Lakes, Florida, United States|Clinical Pharmacology of Miami, Miami, Florida, United States|Endoscopic Research Inc, Orlando, Florida, United States|Synexus Clinical Research US, Inc - Orlando, Orlando, Florida, United States|Synexus Clinical Research US, Inc., The Villages, Florida, United States|AES/Synexus - Atlanta, Atlanta, Georgia, United States|Synexus Clinical Research, Chicago, Illinois, United States|Indiana University Health Hospital, Indianapolis, Indiana, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, United States|Heartland Research Associates, Newton, Kansas, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, United States|Heartland Research Associates, Wichita, Kansas, United States|Tandem Clinical Research,LLC, Marrero, Louisiana, United States|The National Diabetes & Obesity Research Institute (NDORI), Biloxi, Mississippi, United States|Southern Therapy and Advanced Research (STAR) LLC, Jackson, Mississippi, United States|Montefiore Medical Center, Bronx, New York, United States|University at Buffalo-Clinical and Translational Research Center, Buffalo, New York, United States|NYU Langone Medical Center, New York, New York, United States|Mount Sinai School of Medicine, New York, New York, United States|Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, United States|Geisinger Clinic, Danville, Pennsylvania, United States|WR-Clinsearch, LLC, Chattanooga, Tennessee, United States|Texas Diabetes & Endocrinology, P.A., Austin, Texas, United States|Dallas Diabetes Research Center, Dallas, Texas, United States|Liver Center of Texas, PLLC, Dallas, Texas, United States|Synexus - Dallas, Dallas, Texas, United States|Soma Clinical Trials, LLC, Denison, Texas, United States|American Research Corporation at Texas Liver Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, San Antonio, Texas, United States|Synexus - San Antonio, San Antonio, Texas, United States|National Clinical Research, Inc, Richmond, Virginia, United States|Virginia Commonwealth University Medical Center Gastroenterology Hepatology, Richmond, Virginia, United States|Harborview Medical Center/University of Washington, Seattle, Washington, United States|UZ Gent Hospital, Gent, East Flanders, Belgium|Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven, Flemish Brabant, Belgium|AZ Delta, Roeselare, West Flanders, Belgium|UZ Brussel, Brussel, Belgium|Universitair Ziekenhuis Antwerpen, Edegem, Belgium|H??pital Saint Antoine, Paris, Cedex 12, France|Centre Hospitalier Universitaire d'Angers, Angers, Cedex 9, France|CHU Rangueil, Toulouse, Cedex, France|CHRU de Limoges Hopital Dupuytren, Limoges CEDEX, France|H??pital Piti??-Salp??tri??re - IM2A, Paris, France|Chu Haut-Leveque, Pessac, France|Centre Hospitalier Lyon Sud, Pierre Benite Cedex, France|Groupe hospitalier mutualiste Les Portes du sud, Venissieux, France|Sheba Medical Center, Ramat Gan, HaMerkaz, Israel|Rambam Medical Center, Haifa, Israel|Shaare Zedek Medical Center, Jerusalem, Israel|Hadassah Medical Center, Jerusalem, Israel|Galilee Medical Center - Internal A, Nahariya, Israel|Carmel Hospital, Haifa, ???eif??, Israel|Policlinico Gemelli - Universit?? Cattolica del Sacro Cuore, Roma, Lazio, Italy|Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia, Foggia, Italy|Ospedale Santa Maria Goretti, Latina, Italy|Ospedale Maggiore di Milano, Milano, Italy|A.O. Universitaria Policlinico P. Giaccone, Palermo, Italy|A.O.U. Citta' della Salute e della Scienza di Torino, Torino, Italy|Aichi Medical University Hospital, Nagakute-shi, Aichi-ken, Japan|JCHO Hokkaido Hospital, Sapporo-shi, Hokkaido, Japan|Yokohama City University Hospital, Yokohama, Kanagawa, Japan|National Hospital Organization Yokohama Medical Center, Yokohama, Kanagawa, Japan|JADECOM Nara City Hospital, Nara-Shi, Nara-Ken, Japan|Hirakata kohsai Hospital, Higashi-cho, Hirakata-city, Osaka, Japan|Osaka Saiseikai Suita hospital, Suita, Osaka, Japan|Shimane University Hospital, Izumo, Shimane, Japan|Tokyo Medical and Dental University Hospital, Bunky??, Tokyo, Japan|Fukuiken Saiseikai Hospital, Fukui, Japan|Gifu Municipal Hospital, Gifu, Japan|Kumamoto Shinto General Hospital, Kumamoto, Japan|Kyoto Furitsu Medical University Hospital, Kyoto, Japan|Niigata University Medical & Dental Hospital, Niigata, Japan|Saga Medical School Hospital, Saga, Japan|Yamagata University Hospital, Yamagata, Japan|Grupo Medico Camino Sc, M??xico City, Distrito Federal, Mexico|Phylasis Clinicas Research, Cuautitlan Izcalli, Estado De Mexico, Mexico|Centro de Inv y Gastroenterolo, Mexico City, MX, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Depto Gastroenterolog??a, Monterrey, Nuevo Le??n, Mexico|Christus Muguerza Sur S.A. de C.V., Monterrey, Nuevo Le??n, Mexico|Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa, Mazowieckie, Poland|Synexus Polska Sp. z o.o. Oddzial w Lodzi, Lodz, Poland|Hospital Universitario Marqu??s de Valdecilla, Santander, Cantabria, Spain|Hospital Puerta De Hierro, Majadahonda, Madrid, Spain|Hospital Universitario Son Espases, Palma De Mallorca, Palma De Mallorca (Baleares), Spain|Instituto de Ciencias M??dicas, Alicante, Spain|Hospital Universitario Ram??n y Cajal, Madrid, Spain|Hospital Universitario Virgen Del Rocio, Sevilla, Spain|Cl??nica nuevas Tecnolog??as en Diabetes y Endocrinolog??a (NTDE), Seville, Spain|Synexus Midlands Clinical Research Center, Edgbaston, Birmingham, United Kingdom|Kings College Hospital, London, Greater London, United Kingdom|Queen's Medical Centre, Nottingham University Hospitals, Nottingham, Nottinghamshire, United Kingdom|The John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom|Queen Elizabeth Hospital, Birmingham, West Midlands, United Kingdom|Synexus Lancashire Clinical Research Centre, Chorley, United Kingdom|Synexus North East Clinical Research Centre, Hexham, United Kingdom|Aintree University Hospital NHS Foundation Trust, Liverpool, United Kingdom|Barts Health NHS Trust, London, United Kingdom|St. George's University Hospitals NHS Foundation Trust, London, United Kingdom|Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom|Synexus Manchester Clinical Research Centre, Manchester, United Kingdom|Synexus North Teesside Clinical Research Centre, Stockton-on-Tees, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT04166773