Clinical Research Studies

This is a Phase 4 multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a randomized, double-blind, placebo-controlled, parallel-group study in patients with PBC. This fixed-duration study (156 weeks) will randomize approximately 192 subjects across approximately 150 sites worldwide. The population to be studied is patients with PBC and compensated cirrhosis restricted to CP-A or CP-B. Key inclusion criteria include confirmed diagnosis of PBC as defined by having any 2 of the following 3 diagnostic criteria: 1) history of elevated ALP, GGT, or conjugated bilirubin of at least 6 months; 2) positive AMA titer or other PBC-specific antibodies; or 3) documented liver biopsy results consistent with PBC. Eligible subjects must have compensated CP-A or CP-B cirrhosis based on prespecified histologic, radiographic, biochemical, and/or clinical criteria. Current UDCA therapy is not a requirement for this study. However, if a subject is not taking UDCA, the subject should have a history of an inadequate response or intolerance to UDCA per Investigator assessment. If subjects are taking UDCA, the dose should be stable for at least 12 weeks prior to Screening. Key exclusion criteria include ALP =10×ULN, ALT or AST =5×ULN, and TB =5×ULN. Subjects are also excluded for history of, or listed for, liver transplant (unless on a transplant list despite relatively early-stage disease per region guidelines); presence or history of decompensated cirrhosis; CP-C cirrhosis; overlapping AIH; hepatitis A, B, or C; or hepatocellular carcinoma (diagnosed or suspected). Use of OCA or fibrates within 6 weeks prior to Screening is also exclusionary. The study includes a 5-week screening, a 156-week treatment period, and a 2-week safety follow-up period.