Primary Biliary Cirrhosis (PBC) Clinical Trial
Official title:
A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)
A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study, to evaluate the effects of two doses of seladelpar/MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA)
Primary:
To evaluate the effect of MBX-8025 on Alkaline Phosphatase (AP) levels
Secondary:
To evaluate the safety and tolerability of MBX-8025 in subjects with Primary Biliary
Cirrhosis (PBC) To evaluate the effects of MBX-8025 on Primary Biliary Cirrhosis (PBC)
response criteria To evaluate the effects of MBX-8025 on other markers of liver function,
lipids, pruritus and Quality of Life (QoL)
Exploratory:
To evaluate the effect of MBX-8025 on liver imaging and other biochemical markers that may be
relevant to the pathophysiology of PBC or the mechanism of action of the drug
;