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

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT03248882

Run by

Pfizer

People needed

305

Starts

2017-08-22

Expected to finish

2019-03-27

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• eStudySite — Chula Vista, California, United States
• San Diego Imaging Chula Vista — Chula Vista, California, United States
• University of California, San Diego (Altman Clinical and Translational Research Institute) — La Jolla, California, United States
• University of California, San Diego — La Jolla, California, United States
• eStudySite — La Mesa, California, United States
• Clinical Trials Research — Lincoln, California, United States
• National Research Institute — Los Angeles, California, United States
• Stanford University Medical Center, Blake wilbur Building — Palo Alto, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Huntington Medical Research Institute — Pasadena, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Precision Research Institute — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• South Denver Gastroenterology, P.C. — Englewood, Colorado, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States
• Stand Up MRI of Miami — Miami, Florida, United States
• Ocean Blue Medical Research Center, Inc — Miami Springs, Florida, United States
• Avail Clinical Research, LLC — Orange City, Florida, United States
• Bioclinica Research — Orlando, Florida, United States
• Advanced Gastroenterology Associates, LLC — Palm Harbor, Florida, United States
• Qps-Mra, Llc — South Miami, Florida, United States
• Tampa General Medical Group — Tampa, Florida, United States
• Franco Felizarta MD — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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