Liver biochemistry and lipids
Reductions (LS mean) in ALP from baseline at all time points through month 6 were greater in both seladelpar treatment groups versus the placebo group. At month 3, mean ALP decreased by 3.7% from baseline in the placebo group, whereas it decreased by 35.7% in the seladelpar 5-mg group and by 44.2% in the 10-mg group (LS mean relative (percent) change from baseline and mean absolute values for ALP (A and B) and ALT (C and D) through month 6. *Reductions from baseline in ALT were also greater in the seladelpar groups versus the placebo group at all time points through month 6, with LS mean (median) reductions of 4.0% (3.0%), 23.4% (24.3%), and 16.7% (28.3%) observed in the placebo, 5-, and 10-mg groups, respectively, at month 3 (Figure Compared with placebo, seladelpar was associated with greater improvements in other serum liver biochemical markers and in lipid levels through month 6. At month 3, LS mean reductions in total and indirect bilirubin were 6.1% and 6.5%, respectively, in the seladelpar 5-mg group and 4.0% and 6.8%, respectively, in the 10-mg group, while patients receiving placebo experienced a 0.9% increase in total bilirubin and a 1.1% increase in indirect bilirubin (Supplemental Figure S5A-B, S5E-F, At month 3, seladelpar decreased mean total cholesterol, LDL-cholesterol (LDL-C), and triglyceride levels by 3.7%, 5.6%, and 5.9%, respectively, in the 5-mg group and by 4.4%, 8.2%, and 13.1%, respectively, in the 10-mg group compared with decreases of 1.8%, 0.6%, and 0.6%, respectively, in the placebo group (Supplemental Figure S5K–P, 