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Seladelpar 5 mg for Primary Biliary Cirrhosis

Phase 3
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 months
Awards & highlights

Study Summary

This trial looks at whether seladelpar can improve cholestasis (a build-up of bile in the liver) over 12 months, and whether it is safe to take.

Eligible Conditions
  • Primary Biliary Cirrhosis

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite endpoint of ALP and total bilirubin
Secondary outcome measures
Change in baseline numerical rating scale (NRS)
Normalization of ALP

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Seladelpar 5 mgExperimental Treatment1 Intervention
Group II: Seladelpar 10 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seladelpar 5 mg
2021
Completed Phase 3
~200
Seladelpar 10 mg
2021
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

CymaBay Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
3,063 Total Patients Enrolled
~47 spots leftby Jun 2025
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