5 results
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…
The main objectives are:• To assess canagliflozin target (i.e. receptor) specific binding in vivo• To assess receptor occupancy of canagliflozin in vivo• To determine optimal scanning time in vivoTo explore the relationship between canagliflozin…
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 long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar• To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)Exploratory• To evaluate the effect of…
Primary objective:• To evaluate the anticancer efficacy of INBRX-109 in the intention-to-treat (ITT) population as measured by progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECISTv1.1), assessed by…