3 results
This study is not intended to improve your health, but is necessary for the further development of RO7034067 .The study will be performed in 3 parts, Parts 1, 2 and 3. This document only refers to Part 1/2/3 of the study . Part 1:A single dose will…
Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…
Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…