Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Study Summary

To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA). The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.

Conditions

Primary Biliary Cholangitis

Interventions / Drugs

Seladelpar 10 mg Placebo

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment90 participants

Primary Completion—

Lead SponsorGilead Sciences

Data Retrieved2026-04-11 02:55:27.112666+00:00

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