Conditions: Primary Biliary Cirrhosis (PBC)
Keywords: PBC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

Detailed description:
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)

Arms:
arm 1: Participants received 2 placebo-to-match (PTM) seladelpar capsules, orally, once daily for 12 weeks. arm 2: Participants received seladelpar 50 mg capsule (1 x 50 mg capsule) and a PTM seladelpar capsule, orally, once daily for 12 weeks. arm 3: Participants received seladelpar 200 mg capsules (2 x 100 mg capsules), orally, once daily for 12 weeks.

Interventions: intervention 1: Placebo Comparator intervention 2: Experimental: Seladelpar 50 mg intervention 3: Experimental: Seladelpar / MBX-8025 200 mg
Intervention descriptions: intervention 1: Placebo Capsule intervention 2: Seladelpar 50 mg capsule intervention 3: Seladelpar 100 mg capsules

Protocol document: