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Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

NCT04321031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2025-03-21

Study results available
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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

  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis With Liver Fibrosis

Interventions

DRUG

Placebo

Tablet

DRUG

PF-06865571

Tablet

DRUG

PF-05221304

Tablet

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2024-01-23
Completion
2024-02-21
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • China
  • Hong Kong
  • India
  • Japan
  • Poland
  • Puerto Rico
  • Slovakia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321031 on ClinicalTrials.gov