A study evaluating 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)

Registry ID

EUCTR2016-002996-91

Source registry

EUCTR

Status

Completed

Phase

PHASE2

Sponsor

CymaBay Therapeutics, Inc.

Start date

2017-02-21

Completion date

2019-07-08

Last update

2026-08-16

Conditions

• Primary Biliary Cholangitis

Summary

To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, 10 mg, and 20 mg over 8 weeks of treatment

Locations

• , , Germany
• , , UK

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• A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
• LEOPARD Prospective Validation Cohort 1
• LEOPARD Training and Validation Data Collection Study
• A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA

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