Livdelzi Phase 3 IDEAL trial meets primary endpoint in PBC patients with elevated ALP

Gilead said the Phase 3 IDEAL trial of Livdelzi (seladelpar) met its primary endpoint, a composite of alkaline phosphatase at or below 1.0 times the upper limit of normal with a 15% or greater drop from baseline at Week 52. The trial enrolled 96 adults with primary biliary cholangitis whose ALP was above normal despite or intolerant to ursodeoxycholic acid. Full data are to be presented at a future medical congress.

• Statistically significant improvement versus placebo on the composite ALP endpoint at Week 52
• 96 adults with PBC, ALP above normal but under 1.67 times the upper limit
• Population often underrepresented in prior randomized trials
• No new safety concerns reported; full data to come at a congress