drugset / Trial / NCT04399538

Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis

NCT04399538

Phase 2 Completed 75 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindBasic science

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

Drugs

EvaluationDrugModalityDoseRoute
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