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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03776175 | A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease. | PHASE2 | COMPLETED | 99 | — | — | Jan 4, 2019 | Oct 11, 2019 | Sep 23, 2020 | 29 | United States |
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures 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 = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (PF 05221304) BID Placebo (PF 06865571) BID |
| PF-05221304 Monotherapy | EXPERIMENTAL | 15 mg PF-05221304 BID Placebo (PF-06865571) BID |
| PF-06865571 Monotherapy | EXPERIMENTAL | Placebo (PF-05221304) BID 300 mg PF-06865571 BID |
| PF-05221304 and PF-06865571 Combination | EXPERIMENTAL | 15 mg PF-05221304 BID 300 mg PF-06865571 BID |
| Name | Type | Description |
|---|---|---|
| PF-05221304 Monotherapy | DRUG | Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42. |
| PF-06865571 Monotherapy | DRUG | Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42. |
| Placebo | DRUG | Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42. |
| PF-05221304 and PF-06865571 Combination | DRUG | Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42. |
Inclusion Criteria: * Male subjects or female subjects of non childbearing potential * Total body weight of \>50 kg (110 lbs) and a BMI greater than or equal to 25 kg/m2 * Medical diagnosis of Type 2 Diabetes Mellitus (T2DM) being treated with no more than 1 acceptable oral antidiabetic drug OR Sub...