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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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
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Honolulu, Hawaii 96814
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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711 West 38th Street
Austin, Texas 78705
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Bakersfield, California 93301
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
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Catonsville, Maryland 21228
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6035 Shallowford Road
Chattanooga, Tennessee 37421
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Chula Vista, California 91911
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765 Medical Center Court
Chula Vista, California 91911
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Cincinnati, Ohio 45219
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Detroit, Michigan 48202
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Englewood, Colorado 80113
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2510 Lakeland Drive
Flowood, Mississippi 39232
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Honolulu, Hawaii 96814
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6620 Main Street
Houston, Texas 77030
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Indianapolis, Indiana 46260
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1225 North State Street
Jackson, Mississippi 39202
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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La Mesa, California 91942
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Lincoln, California 95648
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Maroubra, New South Wales 2035
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Miami, Florida 33145
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Miami Springs, Florida 33166
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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860 Peachwood Drive
Orange City, Florida 32763
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100 West Gore Street
Orlando, Florida 32806
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Palm Harbor, Florida 34684
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Palo Alto, California 94304
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Rialto, California 92377
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Rochester, Minnesota 55905
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500 Linden Oaks
Rochester, New York 14623
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Rochester, New York 14623
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Rollingwood, Texas 78746
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San Antonio, Texas 78265
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325 Sacramento Street
San Francisco, California 94111
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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South Miami, Florida 33143
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Tampa, Florida 33606
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3347 State Road 7
Wellington, Florida 33449
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928 Saint Francis North
Wichita, Kansas 67214
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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