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Clinical Trial Summary

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)


Clinical Trial Description

Primary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment Secondary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment To evaluate the pharmacokinetics (PK) of MBX-8025 Exploratory: To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02955602
Study type Interventional
Source CymaBay Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 28, 2016
Completion date July 8, 2019

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