Clinical Trial Details

Trial ID: L0042
Source ID: NCT03248882
Associated Drug: PF-05221304
Title: Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03248882/results
Conditions: Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis
Interventions: Drug: Placebo|Drug: PF-05221304
Outcome Measures: Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16|Percent Change From Baseline in Alanine Aminotransferase at Week 16|Number of Participants With Treatment-Emergent Adverse Events|Number of Participants With Laboratory Abnormalities|Number of Participants With Vital Signs Data Meeting Predefined Criteria|Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria
Sponsor/Collaborators: Pfizer
Gender: All
Age: 18 Years to 70 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 305
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: August 22, 2017
Completion Date: March 27, 2019
Results First Posted: March 10, 2020
Last Update Posted: December 9, 2020
Locations: Franco Felizarta MD, Bakersfield, California, United States|eStudySite, Chula Vista, California, United States|San Diego Imaging Chula Vista, Chula Vista, California, United States|University of California, San Diego (Altman Clinical and Translational Research Institute), La Jolla, California, United States|University of California, San Diego, La Jolla, California, United States|eStudySite, La Mesa, California, United States|Clinical Trials Research, Lincoln, California, United States|National Research Institute, Los Angeles, California, United States|Stanford University Medical Center, Blake wilbur Building, Palo Alto, California, United States|Stanford University Medical Center, Palo Alto, California, United States|Huntington Medical Research Institute, Pasadena, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|Precision Research Institute, San Diego, California, United States|Quest Clinical Research, San Francisco, California, United States|South Denver Gastroenterology, P.C., Englewood, Colorado, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, United States|Borland-Groover Clinic, Jacksonville, Florida, United States|Ocean Blue Medical Research Center, Inc, Miami Springs, Florida, United States|Schiff Center for Liver Diseases/University of Miami, Miami, Florida, United States|Stand Up MRI of Miami, Miami, Florida, United States|Avail Clinical Research, LLC, Orange City, Florida, United States|Bioclinica Research, Orlando, Florida, United States|Advanced Gastroenterology Associates, LLC, Palm Harbor, Florida, United States|Qps-Mra, Llc, South Miami, Florida, United States|Tampa General Medical Group, Tampa, Florida, United States|University of South Florida, Tampa, Florida, United States|South Florida Center Of Gastroenterology, PA, Wellington, Florida, United States|Independent Imaging, Wellington, Florida, United States|East-West Medical Research Institute, Honolulu, Hawaii, United States|Invision Imaging, Honolulu, Hawaii, United States|Midwest Institute for Clinical Research, Indianapolis, Indiana, United States|Heartland Research Associates, LLC, Wichita, Kansas, United States|Ascension Via Christi Imaging at St. Francis, Wichita, Kansas, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Ochsner Medical Center, New Orleans, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Digestive Disease Associates, PA, Catonsville, Maryland, United States|University of Michigan, Ann Arbor, Michigan, United States|Henry Ford Health System, Detroit, Michigan, United States|Mayo Clinic- Main Campus, Rochester, Minnesota, United States|Gastrointestinal Associates, PA, Flowood, Mississippi, United States|Colonnades at Baptist, Jackson, Mississippi, United States|BioTelemetry Research, Rochester, New York, United States|Investigational Drug Service, University of North Carolina Hospitals, Chapel Hill, North Carolina, United States|The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC), Chapel Hill, North Carolina, United States|The University of North Carolina at Chapel Hill, Biomedical Research Imaging Center (MRI Facility), Chapel Hill, North Carolina, United States|Wake Research Associates, LLC, Raleigh, North Carolina, United States|PMG Research of Wilmington, LLC, Wilmington, North Carolina, United States|PMG Research, Inc., Winston-Salem, North Carolina, United States|Sterling Research Group, Ltd., Cincinnati, Ohio, United States|Prime Imaging (Chattanooga Outpatient Center), Chattanooga, Tennessee, United States|ClinSearch, Chattanooga, Tennessee, United States|Touchstone, Austin, Texas, United States|Baylor College of Medicine - Advanced Liver Therapies, Houston, Texas, United States|Pinnacle Clinical Research, Rollingwood, Texas, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, United States|Pinnacle Clinical Research, PLLC, San Antonio, Texas, United States|Clinical Research Advantage, Inc./Wasatch Peak Family Practice, Layton, Utah, United States|National Clinical Research - Richmond, Inc., Richmond, Virginia, United States|Harborview Medical Center, Seattle, Washington, United States|Australian Clinical Research Network, Maroubra, New South Wales, Australia|Spectrum Medical Imaging, Randwick, New South Wales, Australia|Castlereagh Imaging, Westmead, New South Wales, Australia|Storr Liver Centre, Westmead Hospital, Westmead, New South Wales, Australia|Dr. Jones & Partners Medical Imaging, Adelaide, South Australia, Australia|Royal Adelaide Hospital, Department of Gastroenterology and Hepatology, Adelaide, South Australia, Australia|Flinders Medical Centre/Department of Gastroenterology & Hepatology, Adelaide, South Australia, Australia|Radiology SA, Adelaide, South Australia, Australia|Royal Melbourne Hospital, Parkville, Victoria, Australia|Dr TG Elliott Inc - BC Diabetes, Vancouver, British Columbia, Canada|False Creek Healthcare Centre, Vancouver, British Columbia, Canada|False Creek Healthcare, Vancouver, British Columbia, Canada|LAIR Centre, Vancouver, British Columbia, Canada|Discovery Clinical Services Ltd., Victoria, British Columbia, Canada|West Coast Medical Imaging, Victoria, British Columbia, Canada|Nova Scotia Health Authority, QEII Health Sciences Centre, Halifax, Nova Scotia, Canada|Nova Scotia Health Authority, QEII Health Sciences Centre, Halifax, Nova Scotia, Canada|Nova Scotia Health Authority - QEII Health Sciences Centre, Halifax, Nova Scotia, Canada|Aggarwal and Associates Limited, Brampton, Ontario, Canada|St. Joseph's Health Care London, London, Ontario, Canada|London Health Sciences Centre - University Hospital, London, Ontario, Canada|Oxford Medical Imaging, Mississauga, Ontario, Canada|LMC Clinical Research Inc. (Bayview), Toronto, Ontario, Canada|St. Michael's Hospital - MRI Research Centre, Toronto, Ontario, Canada|St. Michael's Hospital, Toronto, Ontario, Canada|University Health Network (UHN) - Toronto General Hospital - Toronto Centre for Liver Disease (TCLD), Toronto, Ontario, Canada|University of Toronto - Toronto General Hospital, Toronto, Ontario, Canada|University Health Network (UHN), Toronto, Ontario, Canada|Toronto Liver Centre - Liver Care Centre Corporation, Toronto, Ontario, Canada|Resonance Magnetique du Saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, Canada|Ecogene-21, Chicoutimi, Quebec, Canada|Medpharmgene Inc, Montreal, Quebec, Canada|Clinique de Medecine Urbaine du Quartier Latin, Montreal, Quebec, Canada|Centre de recherche du CHUM, Montreal, Quebec, Canada|Cedar Cancer Center - McGill University Health Centre, Montreal, Quebec, Canada|Chronic Viral Illness Service - Royal Victoria Hospital - McGill University Health Centre (MUHC), Montreal, Quebec, Canada|McGill University Health Centre, Montreal, Quebec, Canada|Research Institute of the MUHC, Montreal, Quebec, Canada|Radiologie Varad, Montreal, Quebec, Canada|Centre Int??gr?? Universitaire de Sant?? et de Services Sociaux (CIUSSS) de l'Estrie, Sherbrooke, Quebec, Canada|Recherche Medicale St-Jerome Inc, St-Jerome, Quebec, Canada|IRM Quebec, Quebec, Canada|IRM Quebec, Quebec, Canada|CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL), Quebec, Canada|Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec, Quebec, Canada|Centre de recherche Saint-Louis, Quebec, Canada|IRM Qu??bec - Clinique St-Louis, Quebec, Canada|Alpha Recherche Clinique, Quebec, Canada|Clinix, Quebec, Canada|Hillel Yaffe Medical Center, Hadera, Israel|Rambam Health Care Campus, Haifa, Israel|Lady Davis Carmel Medical Center, Haifa, Israel|Shaare Zedek Medical Center, Jerusalem, Israel|Hadassah Hebrew University Medical Center - Ein Kerem, Jerusalem, Israel|Galilee Medical Center, Nahariya, Israel|Holy Family Hospital, Nazareth, Israel|Rabin Medical Center, Petah Tikva, Israel|The Chaim Sheba Medical Center, Ramat-Gan, Israel|Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel|ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok, Poland|Synexus Polska Sp. z o.o. Oddzial w Gdansku, Gdansk, Poland|Centrum Badan Klinicznych PI-House Sp. z o.o., Gdansk, Poland|Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia, Poland|Osrodek Badan Klinicznych, Jaworze, Poland|Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice, Poland|Silmedic Sp. z o.o. Oddzial w Katowicach, Katowice, Poland|Centrum Medyczne A-Z Clinic, Krakow, Poland|Krakowskie Centrum Medyczne sp. z o.o., Krakow, Poland|Gabinet Lekarski Malgorzata Saryusz-Wolska, Lodz, Poland|Synexus Polska Sp. z o.o Oddzial w Poznaniu, Poznan, Poland|Centrum Medyczne Medyk, Rzeszow, Poland|Synexus Polska Sp. z o. o. Oddzial w Warszawie, Warszawa, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych, Wroclaw, Poland|Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw, Poland|DOBROSTAN - Gabinety Lekarskie, Wroclaw, Poland|Changhua Christian Hospital, Changhua city, Changhua County, Taiwan|Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan|National Cheng-Kung University Hospital, Tainan, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Taipei Veterans General Hospital, Taipei, Taiwan
URL: https://ClinicalTrials.gov/show/NCT03248882