Skip to main content
. 2024 Mar 22;80(5):1291–1300. doi: 10.1097/HEP.0000000000000864

TABLE 1B.

Change in the alkaline phosphatase values for the active drug and placebo groups in the key phase 2 and 3 trials in PBC

Trial agent Maximum percentage change in ALP in active drug group from baseline Percentage improvement in ALP in the placebo group from baseline
OCA phase 224 −25 −3
OCA phase 3 (“POISE”)16 −41 −4
OCA phase 3 confirmatory (“COBALT”) (12-month data)25 −28 18
Bezafibrate phase 317 −60 0
Elafibranor phase 3 (“ELATIVE”)21 −39 1.7
Seladelpar phase 3 (“ENHANCE”)20 −42 0
Budesonide phase 226 −29 −2.5

Abbreviation: ALP, alkaline phosphatase.