In a phase III, double-blind, placebo-controlled trial, 193 patients with primary biliary cholangitis and an inadequate response to or a history of unacceptable side effects with ursodeoxycholic acid were randomly assigned in a 2:1 ratio to receive daily 10 mg oral seladelpar (a PPARδ agonist) or placebo.

The primary endpoint was set at month 12 as a biochemical response defined as an alkaline phosphatase serum level less than 1.67 times the upper limit of the normal range, with a decrease of 15% or more from baseline, and a normal total bilirubin serum level. Of 193 patients, 93.8% received ursodeoxycholic acid as standard-of-care background therapy.