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
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
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).
Inclusion Criteria:
Exclusion Criteria:
La Jolla, California 92037, United States
La Jolla, California 92037, United States
Los Angeles, California 90048, United States
Los Angeles, California 90048, United States
New Haven, Connecticut 06511, United States
New Haven, Connecticut 06519, United States
Miami, Florida 33156, United States
Wyoming, Michigan 49519, United States
New York, New York 10029, United States
Pittsburgh, Pennsylvania 15213, United States
Pittsburgh, Pennsylvania 15213, United States
Pittsburgh, Pennsylvania 15213, United States
Nashville, Tennessee 37232, United States
Nashville, Tennessee 37232, United States
Halifax, Nova Scotia B3H 1V7, Canada
Chicoutimi, Quebec G7H 5H6, Canada
Montreal, Quebec H2X 0A9, Canada
Kolkata, West Bengal 700020, India
Inashiki-gun, Ibaraki 300-0395, Japan
Ohmura, Nagasaki 856-8562, Japan
Katowice, 40-752, Poland
Krakow, 31-061, Poland
Bratislava - Mestska Cast Nove Mesto, 831 01, Slovakia
Bratislava - Mestska Cast Ruzinov, 831 04, Slovakia
Kosice - Mestska Cast Zapad, 040 11, Slovakia
Nitra, 949 01, Slovakia
Dongjak-gu, Seoul 07061, South Korea