Clinical Research Studies

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of seladelpar in patients with PBC and ALP values greater than ULN but less than 1.67×ULN with either concomitant UDCA treatment or an intolerance to UDCA. Approximately 75 subjects will be randomized in a 2:1 ratio (seladelpar:placebo) across approximately 26 sites. Screening Period The Screening Period will be up to 4 weeks, during which time subject eligibility will be confirmed. Subjects must use the study-issued electronic device or app for at least 14 days. On Day 1, subjects will be randomized and enter the Treatment Period. Double-blind Treatment Period On Day 1 (Visit 2), subjects will be randomized into 1 of 2 treatment groups (seladelpar 10 mg or placebo) in a 2:1 ratio. Subjects will be stratified at randomization according to ALP levels (1×ULN < ALP < 1.3×ULN versus 1.3×ULN = ALP < 1.67×ULN) to ensure balance across the treatment groups. Subjects will receive double-blinded treatment for 52 weeks. Clinic visits will occur at Weeks 4, Week 12, Week 26, Week 39, and Week 52 (Visits 3 to 7). Week 52 is the End of Treatment (EOT) visit. Safety Follow-up Period Subjects will have a follow-up visit performed 2 weeks after the last dose of study drug, including subjects who discontinue treatment early.