PF-05221304

Evidence outlook · lead readout

NCT04321031 · Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis

The completed lead evidence is positive, with design limits that temper confidence — see the rationale below for exactly which.

NCT04321031: The study was randomized, quadruple-blind, placebo-controlled, and included 256 participants, with liver-biopsy-based NASH and fibrosis outcomes as the primary endpoint. The reported primary comparison for the PF-05221304 combination arms favored treatment, but the combination groups included only 35 and 30 participants and were excluded from another prespecified primary analysis, limiting the strength of the evidence.