Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).

Official Title

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I) ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3

Keywords

Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis With Liver Fibrosis Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Liver Cirrhosis Fibrosis PF-06865571 25 milligrams (mg) twice daily (BID) PF-06865571 75 mg BID PF-06865571 150 mg BID PF-06865571 300 mg BID PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID) PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)

Eligibility

You can join if…

Open to people ages 18-75

  • Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
  • BMI >/= 22.5kg/m2

You CAN'T join if...

  • Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
  • Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
  • unstable liver function tests, recent cardiovascular event(s) significant malignancies,

Locations

  • University of California San Diego, Altman Clinical and Translational Research Institute Clinic accepting new patients
    La Jolla California 92037 United States
  • UCSD Altman Clinical and Transitional Research Institute accepting new patients
    La Jolla California 92093 United States
  • Altman Clinical and Translational Research Institute (ACTRI) accepting new patients
    La Jolla California 92037 United States
  • Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI) accepting new patients
    La Jolla California 92037 United States
  • Sharp and Children's MRI Center, LLC accepting new patients
    San Diego California 92123-2731 United States
  • Wake Research MCCR accepting new patients
    San Diego California 92108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04321031
Phase
Phase 2
Study Type
Interventional
Last Updated