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

• Status: Completed
• Trial end date: 2019-03-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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