Composite biochemical response and ALP normalization
At month 3, significantly greater proportions of patients in the seladelpar 5-mg (57.1%, Proportion of patients who achieved the composite biochemical end point at month 3. Composite end point was defined as alkaline phosphatase (ALP) serum levels < 1.67× upper limit of normal (ULN), ≥15% decrease in ALP serum levels, and total bilirubin serum levels ≤ ULN. The proportion of patients attaining ALP normalization at month 3 (≤1.0×ULN) was greater in the seladelpar 10-mg (27.3%) group versus the placebo (0%, Proportion of patients who achieved alkaline phosphatase (ALP) normalization at month 3 ALP normalization. ALP normalization was defined as serum levels ≤1.0×upper limit of normal. Examining the individual composite end point components, at month 3, 18% of patients in the placebo group, 64% in the seladelpar 5-mg group, and 82% in the seladelpar 10-mg group achieved ALP < 1.67×ULN, and 23%, 95%, and 95%, respectively, achieved a ≥ 15% decrease from baseline in ALP (Supplemental Table S2, 