Livdelzi improves ALP normalisation rates in Phase III PBC study

Gilead Sciences has reported positive Phase III IDEAL study results showing that Livdelzi significantly improved alkaline phosphatase normalisation in adults with primary biliary cholangitis whose disease remained inadequately controlled despite treatment with ursodeoxycholic acid.

The randomised, double-blind, placebo-controlled study evaluated Livdelzi, also known as seladelpar, in patients with alkaline phosphatase levels above normal but below 1.67 times the upper limit of normal.

This population has generally been excluded from previous pivotal randomised trials of second-line treatments for primary biliary cholangitis.

At Week 52, 75.4% of patients receiving Livdelzi achieved the study’s ALP normalisation composite endpoint compared with 16.1% of those receiving placebo.

The composite endpoint was defined as an alkaline phosphatase level at or below the upper limit of normal together with a reduction of at least 15% from baseline.

The effect was observed early in treatment.

After one month, 52.3% of patients receiving Livdelzi had achieved the endpoint compared with 6.5% of those receiving placebo.

The response was maintained through Week 52.

Alkaline phosphatase is an important marker of disease activity in primary biliary cholangitis, with persistently elevated levels associated with a greater risk of disease progression and poorer long-term outcomes.

Recent clinical guidance has increasingly recognised ALP normalisation as an ideal treatment goal in PBC.

IDEAL enrolled adults with baseline ALP levels between one and 1.67 times the upper limit of normal despite at least 12 months of treatment with ursodeoxycholic acid, or who were unable to tolerate UDCA.

Cynthia Levy, MD, of the University of Miami Miller School of Medicine, said the results provide randomised evidence that seladelpar can improve biochemical response in patients whose ALP elevation falls below the threshold typically used in previous second-line PBC trials.

She said the findings may help support more individualised treatment discussions based on disease progression risk, symptoms and the potential benefits and risks of additional therapy.

Swati Tole, MD, MS, Senior Vice President of Clinical Development, Inflammation at Gilead Sciences, said the results support ALP normalisation as an achievable treatment goal in a broader group of patients with PBC.

The safety profile of Livdelzi was consistent with previous studies, with no new safety concerns identified.

Overall adverse event rates were similar between the treatment and placebo groups.

Serious adverse events were reported in 3.1% of patients receiving Livdelzi and 12.9% of patients receiving placebo, with none considered related to study treatment.

Gilead said it plans to engage with global regulatory authorities based on the IDEAL findings.

The results will be presented at AASLD The Liver Meeting 2026 and have also been accepted for publication in the Journal of Hepatology.

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Related Topics and Keywords

AASLD 2026, alkaline phosphatase, ALP, ALP normalisation, biochemical response, Biopharma, cholestatic liver disease, clinical trials, Gilead Sciences, hepatology, IDEAL, Livdelzi, Liver disease, PBC, pharma news, phase III, primary biliary cholangitis, seladelpar, The Liver Meeting, UDCA, ursodeoxycholic acid