Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:3/21/2019
Start Date:August 22, 2017
End Date:April 8, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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Trial Summary
Trial Overview
Inclusion Criteria

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study
To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For
16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease

Inclusion Criteria:

- Body Mass Index >= 25 kg/m2

- 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:

- Alcohol-induced steatohepatitis or other forms of chronic liver disease

- Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus

- Severe Renal Impairment

- Contraindications for MRI
We found this trial at
63
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University of California, San Diego (Altman Clinical and Translational Research Institute)
La Jolla, California 92037
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
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Borland-Groover Clinic
4800 Belfort Rd # 2
Jacksonville, Florida 32256
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National Research Institute
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Heartland Research Associates, LLC
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Touchstone
711 West 38th Street
Austin, Texas 78705
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Franco Felizarta, MD
Bakersfield, California 93301
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Mercy Medical Center
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
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Digestive Disease Associates, PA
Catonsville, Maryland 21228
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The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina 27599
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Investigational Drug Service, University of North Carolina Hospitals
Chapel Hill, North Carolina 27514
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WR-ClinSearch, LLC
6035 Shallowford Road
Chattanooga, Tennessee 37421
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Prime Imaging (Chattanooga Outpatient Center) MRI Imaging Only
Chattanooga, Tennessee 37404
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eStudy Site, Chula Vista
Chula Vista, California 91911
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San Diego Imaging Chula Vista
765 Medical Center Court
Chula Vista, California 91911
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Sterling Research Group
Cincinnati, Ohio 45219
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Henry Ford Health System
Detroit, Michigan 48202
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South Denver Gastroenterology
Englewood, Colorado 80113
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GastroIntestinal Associates
2510 Lakeland Drive
Flowood, Mississippi 39232
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East-West Medical Research Institute
Honolulu, Hawaii 96814
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Honolulu, HI
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In Vision Imaging
Honolulu, Hawaii 96814
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Baylor College of Medicine - Advanced Liver Therapies
6620 Main Street
Houston, Texas 77030
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Midwest Institute for Clinical Research
Indianapolis, Indiana 46260
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Colonnades at Baptist
1225 North State Street
Jackson, Mississippi 39202
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The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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eStudy Site
La Mesa, California 91942
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Clinical Research Advantage, Inc./Wasatch Peak Family Practice
1580 Antelope Drive
Layton, Utah 84041
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Clinical Trials Research
Lincoln, California 95648
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Australian Clinical Research Network
Maroubra, New South Wales 2035
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Schiff Center for Liver Diseases/University of Miami
Miami, Florida 33136
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Stand-Up MRI of Miami
Miami, Florida 33145
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Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida 33166
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Tulane University Health Sciences Center
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
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Ochsner Medical Center
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Avail Clinical Research, LLC
860 Peachwood Drive
Orange City, Florida 32763
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Bioclinica Research
100 West Gore Street
Orlando, Florida 32806
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Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida 34684
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Stanford University Medical Center
Palo Alto, California 94304
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Stanford University Medical Center, Blake wilbur Building
Palo Alto, California 04304
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Huntington Medical Research Institute
Pasadena, California
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Wake Research Associates, LLC
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
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Inland Empire Liver Foundation
Rialto, California 92377
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National Clinical Research - Richmond, Inc.
Richmond, Virginia 23294
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Mayo Clinic- Main Campus
Rochester, Minnesota 55905
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Virtualscopics/ Biotelemetry Research
500 Linden Oaks
Rochester, New York 14623
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BioTelemetry Research
Rochester, New York 14623
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Pinnacle Clinical Research, PLLC
Rollingwood, Texas 78746
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Pinnacle Clinical Research
San Antonio, Texas 78265
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Precision Research Institute, LLC
San Diego, California 92115
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SimonMed
325 Sacramento Street
San Francisco, California 94111
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Mission Gastroenterology and Hepatology (fibroscan facility)
San Francisco, California 94110
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Quest Clinical Research
San Francisco, California 94115
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Harborview Medical Center
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
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Qps-Mra, Llc
South Miami, Florida 33143
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Tampa General Medical Group
Tampa, Florida 33606
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South Florida Center of Gastroenterology, LLC
Wellington, Florida 33414
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Independent Imaging
3347 State Road 7
Wellington, Florida 33449
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Anatomi Imaging
928 Saint Francis North
Wichita, Kansas 67214
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PMG Research of Wilmington
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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PMG Research of Winston-Salem
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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