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 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

  • 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
  • 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
  • Sharp and Children's MRI Center, LLC in progress, not accepting new patients
    San Diego California 92123-2731 United States
  • WR-MCCR in progress, not accepting new patients
    San Diego California 92120 United States
  • Sharp Coronado Hospital accepting new patients
    Coronado California 92118 United States
  • Southern California Research Center accepting new patients
    Coronado California 92118 United States
  • Precision Research Institute accepting new patients
    San Diego California 92114 United States
  • Magnolia Surgery Center in progress, not accepting new patients
    El Cajon California 92020 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.
ID
NCT04321031
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 350 study participants
Last Updated