Phase 2
N=255
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Nonalcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis With Liver Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04321031 ↗Enrolled (actual)
255
Serious AEs
7.4%
Results posted
Mar 2025
Primary outcome: Primary: Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM) — 0.38; 0.45; 0.48; 0.50 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); PF-06865571 (Drug); PF-05221304 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM) |
0.38; 0.45; 0.48; 0.50; 0.51 | — |
| PRIMARY Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model |
13; 16; 25; 21; 23; 14 | — |
| SECONDARY Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model |
-10.79; -36.76; -46.20; -51.33; -55.53 | — |
| SECONDARY Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA) |
1.41; -41.00; -42.53; -58.77; -67.76; -49.76 | — |
| SECONDARY Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model |
0.11; 0.32; 0.37; 0.40; 0.41 | — |
| SECONDARY Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model |
3; 11; 22; 13; 22; 13 | — |
| SECONDARY Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model |
0.33; 0.28; 0.25; 0.24; 0.22 | — |
| SECONDARY Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model |
12; 10; 10; 14; 13; 4 | — |
| SECONDARY Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model |
0.05; 0.08; 0.09; 0.09; 0.10 | — |
| SECONDARY Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model |
1; 4; 3; 5; 7; 2 | — |
| SECONDARY Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model |
0.24; 0.42; 0.47; 0.49; 0.51 | — |
| SECONDARY Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model |
8; 13; 28; 21; 25; 12 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
26; 25; 38; 30; 25; 26 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
31; 32; 46; 39; 34; 27 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters |
0; 0; 0; 0; 0; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
- BMI >/= 22.5kg/m2
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,
Data sourced from ClinicalTrials.gov (NCT04321031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.