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PF-05221304 Monotherapy · 1 trial · 1 indication
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...
PF-05221304 is an investigational small molecule being studied for non-alcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis. It has also been evaluated in healthy subjects and in people with hepatic impairment. It is not approved and remains in clinical development.
PF-05221304 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer has sponsored multiple clinical trials of the drug in NAFLD and related conditions.
PF-05221304 has completed Phase 1 and Phase 2 clinical trials. The most advanced completed study was a Phase 2a dose-ranging trial in nonalcoholic fatty liver disease. The drug is investigational and has not been approved by regulatory authorities.
PF-05221304 has been studied in four completed trials. NCT02871037 was a Phase 1 single and repeated dose study in healthy subjects. NCT03248882 was a Phase 2a dose-ranging trial in NAFLD. NCT03309202 evaluated the drug in hepatic impairment. NCT03776175 assessed PF-05221304 co-administered with PF-06865571 in NAFLD.
No, PF-05221304 and PF-06865571 are distinct investigational drugs. They were co-administered in one clinical trial, NCT03776175, which assessed the pharmacodynamics, safety, and tolerability of the two drugs given together for six weeks in adults with non-alcoholic fatty liver disease.