Trials / Completed
CompletedNCT04321031
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Tablet |
| DRUG | PF-06865571 | Tablet |
| DRUG | PF-05221304 | Tablet |
Timeline
- Start date
- 2020-06-15
- Primary completion
- 2024-01-23
- Completion
- 2024-02-21
- First posted
- 2020-03-25
- Last updated
- 2025-03-21
- Results posted
- 2025-03-21
Locations
291 sites across 12 countries: United States, Bulgaria, Canada, China, Hong Kong, India, Japan, Poland, Puerto Rico, Slovakia, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04321031. Inclusion in this directory is not an endorsement.