| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03248882 | Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD) | PHASE2 | COMPLETED | 305 | — | — | Aug 22, 2017 | Mar 27, 2019 | Dec 9, 2020 | 140 | United States, Australia +4 |
MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2\* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Double-Blind, PF-05221304-matching Placebo |
| PF-05221304 - 2 mg | ACTIVE_COMPARATOR | PF-05221304 - 2 mg, once-daily |
| PF-05221304 - 10 mg | ACTIVE_COMPARATOR | PF-05221304 - 10 mg, once-daily |
| PF-05221304 - 25 mg | ACTIVE_COMPARATOR | PF-05221304 - 25 mg, once-daily |
| PF-05221304 - 50 mg | ACTIVE_COMPARATOR | PF-05221304 - 50 mg, once-daily |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-05221304 | DRUG | PF-05221304, Experimental Drug |
Inclusion Criteria: * Body Mass Index \>= 25 kg/m2 * Body Weight \> 50 kg * Liver fat (assessed via MRI-PDFF) \>= 8% * Biopsy-proven NASH - diagnosed in previous 24-months * Presumed NASH - per Sponsor's definition * NAFLD with minimal inflammation/fibrosis * Features of Metabolic Syndrome Exclusi...