| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04321031 | Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) | PHASE2 | COMPLETED | 256 | — | — | Jun 15, 2020 | Feb 21, 2024 | Mar 21, 2025 | 291 | United States, Bulgaria +10 |
NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease \[NAFLD\] Activity Score \[NAS\] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity \[DA\]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= \<2 foci, 2=2-4 foci,3= \>4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= \<5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= \>66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2, or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS compared to baseline. No worsening of NASH: no change or increase in NAS for ballooning, inflammation, steatosis compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | participants will receive medication for 48 weeks |
| PF-06865571 25 milligrams (mg) twice daily (BID) | EXPERIMENTAL | participants will receive medication for 48 weeks |
| PF-06865571 75 mg BID | EXPERIMENTAL | participants will receive medication for 48 weeks |
| PF-06865571 150 mg BID | EXPERIMENTAL | participants will receive medication for 48 weeks |
| PF-06865571 300 mg BID | EXPERIMENTAL | participants will receive medication for 48 weeks |
| PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID) | EXPERIMENTAL | participants will receive medication for 48 weeks |
| PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID) | EXPERIMENTAL | participants will receive medication for 48 weeks |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablet |
| PF-06865571 | DRUG | Tablet |
| PF-05221304 | DRUG | Tablet |
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 affect...