Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03256526 | 6-week Safety and PD Study in Adults With NAFLD | PHASE2 | COMPLETED | 53 | — | — | Sep 27, 2017 | Apr 27, 2018 | Apr 4, 2019 | 9 | United States |
The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows: Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed). The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline. The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| PF-06835919 Low Dose | EXPERIMENTAL | 75 mg once daily |
| PF-06835919 High Dose | EXPERIMENTAL | 300 mg once daily |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 0 mg |
| PF-06835919 Low Dose | DRUG | 75 mg once daily |
| PF-06835919 High Dose | DRUG | 300 mg once daily |
Inclusion Criteria: * BMI at least 28 kg/m2 * Type 2 diabetes and/or metabolic syndrome Exclusion Criteria: * Liver disease * Type 1 diabetes * Recent heart attack or stroke * Inability to have an MRI scan