CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 256 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04321031
NCT04321031Phase 2Completed

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

Pfizer·interventional·Posted Mar 25, 2020·Updated Mar 21, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo, PF-06865571, and 1 other intervention for Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis. Completed, enrolled 256 participants across 291 sites in 12 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Canada, China, Hong Kong, India, Japan, Poland, Puerto Rico, Slovakia, South Korea, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 25, 2020
Enrollment StartJun 15, 2020
Primary CompletionJan 23, 2024
Study CompletionFeb 21, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.3 years ago

Interventions

Placebodrug

Tablet

PF-06865571drug

Tablet

PF-05221304drug

Tablet