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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03969719 | A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 164 | — | — | Jul 18, 2019 | Mar 30, 2021 | May 11, 2022 | 106 | United States, Canada |
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Palacebo |
| Low Dose | EXPERIMENTAL | 150 mg |
| High Dose | EXPERIMENTAL | 300 mg |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-06835919 | DRUG | 150 mg once daily |
Inclusion Criteria: * Males, or females of nonchildbearing potential * 18 to 70 years of age * Type 2 Diabetes Mellitus * Liver fat \>/=8% by MRI-PDFF * On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily) Exclusion Criteria: * History of other liver ...