Summary

for people ages 18-70 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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

Keywords

Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis PF-05221304 NAFLD NASH features of metabolic syndrome Dose-Ranging Study Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease

Eligibility

You can join if…

Open to people ages 18-70

  • 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 CAN'T join 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

Locations

  • University of California, San Diego (Altman Clinical and Translational Research Institute) accepting new patients
    La Jolla California 92037 United States
  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States
  • eStudy Site in progress, not accepting new patients
    La Mesa California 91942 United States
  • Precision Research Institute accepting new patients
    San Diego California 92114 United States
  • eStudy Site - Chula Vista accepting new patients
    Chula Vista California 91911 United States
  • San Diego Imaging Chula Vista in progress, not accepting new patients
    Chula Vista California 91911 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT03248882
Phase
Phase 2
Study Type
Interventional
Last Updated
July 3, 2018