Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
← catalyst calendarNCT03301506 · readout ≤ 834 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
340estimated
Sites
109
Countries
Argentina, Australia, Austria +22
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-12-12 | actual | When the study began enrolling |
| Primary completion | Nov 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2017-10-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Biliary Cirrhosis
Interventions
- Drug: Seladelpar 5 mg Capsule — also filed as MBX-8025, Livdelzi®
- Drug: Seladelpar 10 mg Capsule — also filed as MBX-8025, Livdelzi®
Primary outcome
what the primary-completion date above is the date OFTreatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
measured Through study completion, up to 60 Months
Publications
- PMID 40553148 — linked by the registry
- PMID 37904314 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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