Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
96actual
Sites
45
Countries
Canada, United States
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 | 2023-09-05 | actual | When the study began enrolling |
| Primary completion | 2026-05-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-06 | actual | The whole study's end, after follow-up |
| First posted | 2023-09-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | 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 Cholangitis
Interventions
- Drug: Seladelpar 10 mg
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Response defined as Alkaline phosphatase (ALP) ≤ 1.0× Upper Limit of Normal (ULN) AND ≥ 15% Decrease in ALP at Week 52.
measured 52 weeks
Type, Frequency, and Severity of Treatment-emergent Adverse Events.
measured 52 weeks
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