Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT03248882
Last Updated: 2020-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2017-08-22
2019-03-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Double-Blind, PF-05221304-matching Placebo
Placebo
Placebo
PF-05221304 - 2 mg
PF-05221304 - 2 mg, once-daily
PF-05221304
PF-05221304, Experimental Drug
PF-05221304 - 10 mg
PF-05221304 - 10 mg, once-daily
PF-05221304
PF-05221304, Experimental Drug
PF-05221304 - 25 mg
PF-05221304 - 25 mg, once-daily
PF-05221304
PF-05221304, Experimental Drug
PF-05221304 - 50 mg
PF-05221304 - 50 mg, once-daily
PF-05221304
PF-05221304, Experimental Drug
Interventions
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Placebo
Placebo
PF-05221304
PF-05221304, Experimental Drug
Eligibility Criteria
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Inclusion Criteria
* Body Weight \> 50 kg
* Liver fat (assessed via MRI-PDFF) \>= 8%
* Biopsy-proven NASH - diagnosed in previous 24-months
* Presumed NASH - per Sponsor's definition
* NAFLD with minimal inflammation/fibrosis
* Features of Metabolic Syndrome
Exclusion Criteria
* Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
* Severe Renal Impairment
* Contraindications for MRI
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Stand Up MRI of Miami
Miami, Florida, United States
Ocean Blue Medical Research Center, Inc
Miami Springs, 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
IRM Quebec
Québec, Quebec, Canada
IRM Quebec
Québec, Quebec, Canada
CHU de Quebec - Universite Laval - site Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Quebec, Canada
Centre de recherche de l'Institut Universitaire de Cardiologie et de pneumologie de Quebec
Québec, Quebec, Canada
Centre de recherche Saint-Louis
Québec, Quebec, Canada
IRM Québec - Clinique St-Louis
Québec, Quebec, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Clinix
Québec, Quebec, Canada
Recherche Medicale St-Jerome Inc
Saint-Jérôme, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Estrie
Sherbrooke, 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
Rzeszów, , Poland
Synexus Polska Sp. z o. o. Oddzial w Warszawie
Warsaw, , 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, Changhua County, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, , Taiwan
National Cheng-Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Sivakumar P, Saul M, Robinson D, King LE, Amin NB. SomaLogic proteomics reveals new biomarkers and provides mechanistic, clinical insights into Acetyl coA Carboxylase (ACC) inhibition in Non-alcoholic Steatohepatitis (NASH). Sci Rep. 2024 Jul 24;14(1):17072. doi: 10.1038/s41598-024-67843-8.
Calle RA, Amin NB, Carvajal-Gonzalez S, Ross TT, Bergman A, Aggarwal S, Crowley C, Rinaldi A, Mancuso J, Aggarwal N, Somayaji V, Inglot M, Tuthill TA, Kou K, Boucher M, Tesz G, Dullea R, Bence KK, Kim AM, Pfefferkorn JA, Esler WP. ACC inhibitor alone or co-administered with a DGAT2 inhibitor in patients with non-alcoholic fatty liver disease: two parallel, placebo-controlled, randomized phase 2a trials. Nat Med. 2021 Oct;27(10):1836-1848. doi: 10.1038/s41591-021-01489-1. Epub 2021 Oct 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2017-001156-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C1171002
Identifier Type: -
Identifier Source: org_study_id