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 |
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
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
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Chapel Hill, North Carolina 27599
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Chapel Hill, North Carolina 27514
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La Jolla, California 92037
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1580 Antelope Drive
Layton, Utah 84041
Layton, Utah 84041
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
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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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
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...
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