Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Summary
The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.
Timeline
- Start
- 2020-08-10
- Primary completion
- 2022-03-31
- Completion
- 2022-04-28
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs PF-06865571 25 mg BID + PF-05221304 10 mg BID; p <0.0001 NCT04399538 ↗
registry Difference in least square (LS) mean -52.36 (80% CI -60.07 to -43.17); ANCOVA NCT04399538 ↗
registry analysis (superiority test); Placebo vs PF-06865571 300 mg BID + PF-05221304 10 mg BID; p = 0.0003 NCT04399538 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clesacostat | Small molecule | 10 mg | — |
| Subject | Clesacostat | Small molecule | 20 mg | — |
| Subject | PF-06865571 | Small molecule | 25 mg | — |
| Subject | PF-06865571 | Small molecule | 100 mg | — |
| Subject | PF-06865571 | Small molecule | 300 mg | — |