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Seladelpar / MBX-8025 50 mg Dose for Primary Biliary Cirrhosis

Phase 2
Waitlist Available
Research Sponsored by CymaBay Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights

Summary

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)

Eligible Conditions
  • Primary Biliary Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Composite Endpoint of AP and Bilirubin
Laboratory Values
Published PBC response criteria

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Seladelpar / MBX-8025 50 mg DoseExperimental Treatment1 Intervention
MBX-8025 50 mg capsule One Capsule Daily
Group II: Seladelpar / MBX-8025 200 mg DoseExperimental Treatment1 Intervention
MBX-8025 100 mg capsules (2 taken once daily)
Group III: Placebo DosePlacebo Group1 Intervention
Placebo Capsule Two Capsules Daily

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Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,215 Total Patients Enrolled
Pol F Boudes, M.D.Study ChairCymaBay Therapeutics, Inc.
1 Previous Clinical Trials
13 Total Patients Enrolled
~4 spots leftby Sep 2025
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