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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225223

Enrollment

350

Registered

2020-06-09

Start date

2020-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non alcoholic steatohepatitis with fibrosis

Interventions

investigational material(s) Generic name etc : PF-05221304, PF-06865571 INN of investigational material : - Therapeutic category code : 391 Agents for liver disease Dosage and Administration for Inves

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: * Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition * BMI >/= 22.5kg/m2

Exclusion criteria

Exclusion criteria: Exclusion Criteria: * 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,

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of participants achieving resolution of NASH without worsening of fibrosis or improvement in fibrosis by >=1 stage without worsening of NASH or both, based on assessment by sponsor-identified central pathologist(s), at Week 48	—

Secondary

Measure	Time frame
safety efficacy Percent change in liver fat [ Time Frame: Week 48 ] (assessed via MRI-PDFF in substudy population) Proportion of participants achieving Resolution of NASH, without worsening of fibrosis [ Time Frame: Week 48 ] Proportion of participants achieving improvement in fibrosis by >=1stage, without worsening of NASH [ Time Frame: Week 48 ] Proportion of participants with Improvement in fibrosis by >=2 stages, without worsening of NASH [ Time Frame: Week 48 ] Proportion of participants with Improvement of >=2 points in Total NASH [ Time Frame: Week 48 ] Proportion of participants with a clinically significant change from baseline in vital signs Proportion of participants with a clinically significant change from baseline in laboratory values Proportion of participants with a clinically significant change from baseline in electrocardiograms parameters Proportion of participants with treatment-emergent adverse events	—

Measure

Time frame

safety efficacy Percent change in liver fat [ Time Frame: Week 48 ] (assessed via MRI-PDFF in substudy population) Proportion of participants achieving Resolution of NASH, without worsening of fibrosis [ Time Frame: Week 48 ] Proportion of participants achieving improvement in fibrosis by >=1stage, without worsening of NASH [ Time Frame: Week 48 ] Proportion of participants with Improvement in fibrosis by >=2 stages, without worsening of NASH [ Time Frame: Week 48 ] Proportion of participants with Improvement of >=2 points in Total NASH [ Time Frame: Week 48 ] Proportion of participants with a clinically significant change from baseline in vital signs Proportion of participants with a clinically significant change from baseline in laboratory values Proportion of participants with a clinically significant change from baseline in electrocardiograms parameters Proportion of participants with treatment-emergent adverse events

—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026