Seladelpar for alkaline phosphatase normalization in primary biliary cholangitis: The IDEAL phase III randomized controlled trial.

Seladelpar 10 mg once daily normalized alkaline phosphatase in 75.4% of primary biliary cholangitis patients with ALP 1–1.67×ULN at Month 12 versus 16.1% on placebo.

• Why it matters: ALP elevation below 1.67×ULN still reflects disease activity and is linked to progression risk, yet most trials have targeted higher ALP ranges.
• What they did: In a phase III double-blind trial, patients on UDCA or intolerant to UDCA with ALP between 1 and 1.67×ULN were randomized 2:1 to seladelpar 10 mg or placebo for 12 months; the primary endpoint required ALP ≤ULN plus at least a 15% baseline decrease at Month 12.
• The result: At Month 12, the stratum-adjusted treatment difference was 61.3% (95% CI: 44.9%, 77.7%; p<0.0001), with ALP reductions evident from Month 1 and similar adverse event rates; serious adverse events were 3.1% vs 12.9%.

AI summary of the abstract · may contain errors · not medical advice · read the paper.