Status:
COMPLETED
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Pfizer
Conditions:
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Detailed Description
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 Ad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2019
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT03248882
Start Date
August 22 2017
End Date
March 27 2019
Last Update
December 9 2020
Active Locations (140)
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1
Franco Felizarta MD
Bakersfield, California, United States, 93301
2
eStudySite
Chula Vista, California, United States, 91911
3
San Diego Imaging Chula Vista
Chula Vista, California, United States, 91911
4
University of California, San Diego (Altman Clinical and Translational Research Institute)
La Jolla, California, United States, 92037