NCT02609048

Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Primary Biliary Cirrhosis (PBC)

Interventions

Type	Name	Description
DRUG	Placebo Comparator	Placebo Capsule
DRUG	Experimental: Seladelpar 50 mg	Seladelpar 50 mg capsule
DRUG	Experimental: Seladelpar / MBX-8025 200 mg	Seladelpar 100 mg capsules

Timeline

• Start date: 2015-11-04
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-11-20
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

49 sites across 5 countries: United States, Canada, Germany, Poland, United Kingdom