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

Use our guide to learn which trials are right for you!

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
sites
Mercy Medical Center
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Borland-Groover Clinic
4800 Belfort Rd # 2
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
National Research Institute
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Heartland Research Associates, LLC
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
?
mi
from
Wichita, KS
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Touchstone
711 West 38th Street
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Franco Felizarta, MD
Bakersfield, California 93301
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Digestive Disease Associates, PA
Catonsville, Maryland 21228
?
mi
from
Catonsville, MD
Click here to add this to my saved trials
The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Investigational Drug Service, University of North Carolina Hospitals
Chapel Hill, North Carolina 27514
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
WR-ClinSearch, LLC
6035 Shallowford Road
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Prime Imaging (Chattanooga Outpatient Center) MRI Imaging Only
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
eStudy Site, Chula Vista
Chula Vista, California 91911
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
San Diego Imaging Chula Vista
765 Medical Center Court
Chula Vista, California 91911
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Sterling Research Group
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Henry Ford Health System
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
South Denver Gastroenterology
Englewood, Colorado 80113
?
mi
from
Englewood, CO
Click here to add this to my saved trials
GastroIntestinal Associates
2510 Lakeland Drive
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
East-West Medical Research Institute
Honolulu, Hawaii 96814
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
In Vision Imaging
Honolulu, Hawaii 96814
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Baylor College of Medicine - Advanced Liver Therapies
6620 Main Street
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Midwest Institute for Clinical Research
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Colonnades at Baptist
1225 North State Street
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
University of California, San Diego (Altman Clinical and Translational Research Institute)
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
eStudy Site
La Mesa, California 91942
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Clinical Research Advantage, Inc./Wasatch Peak Family Practice
1580 Antelope Drive
Layton, Utah 84041
?
mi
from
Layton, UT
Click here to add this to my saved trials
Clinical Trials Research
Lincoln, California 95648
?
mi
from
Lincoln, CA
Click here to add this to my saved trials
Australian Clinical Research Network
Maroubra, New South Wales 2035
?
mi
from
Maroubra,
Click here to add this to my saved trials
Schiff Center for Liver Diseases/University of Miami
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Stand-Up MRI of Miami
Miami, Florida 33145
?
mi
from
Miami, FL
Click here to add this to my saved trials
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida 33166
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
Tulane University Health Sciences Center
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,...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
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...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Avail Clinical Research, LLC
860 Peachwood Drive
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
Bioclinica Research
100 West Gore Street
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Stanford University Medical Center
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Stanford University Medical Center, Blake wilbur Building
Palo Alto, California 04304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Huntington Medical Research Institute
Pasadena, California
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Wake Research Associates, LLC
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...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Inland Empire Liver Foundation
Rialto, California 92377
?
mi
from
Rialto, CA
Click here to add this to my saved trials
National Clinical Research - Richmond, Inc.
Richmond, Virginia 23294
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Mayo Clinic- Main Campus
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Virtualscopics/ Biotelemetry Research
500 Linden Oaks
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
BioTelemetry Research
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Pinnacle Clinical Research, PLLC
Rollingwood, Texas 78746
?
mi
from
Rollingwood, TX
Click here to add this to my saved trials
Pinnacle Clinical Research
San Antonio, Texas 78265
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Precision Research Institute, LLC
San Diego, California 92115
?
mi
from
San Diego, CA
Click here to add this to my saved trials
SimonMed
325 Sacramento Street
San Francisco, California 94111
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Mission Gastroenterology and Hepatology (fibroscan facility)
San Francisco, California 94110
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Quest Clinical Research
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Harborview Medical Center
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Qps-Mra, Llc
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Tampa General Medical Group
Tampa, Florida 33606
?
mi
from
Tampa, FL
Click here to add this to my saved trials
South Florida Center of Gastroenterology, LLC
Wellington, Florida 33414
?
mi
from
Wellington, FL
Click here to add this to my saved trials
Independent Imaging
3347 State Road 7
Wellington, Florida 33449
?
mi
from
Wellington, FL
Click here to add this to my saved trials
Anatomi Imaging
928 Saint Francis North
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials
PMG Research of Wilmington
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
PMG Research of Winston-Salem
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials