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Clinical Trial Results

Gilead Sciences Reports Positive Results From Phase 3 Study Of Livdelzi For Biliary Cholangitis

By Jamie Kurien  ✉  | Published:  | Google News Follow Us  | Join Us

Gilead Sciences, Inc. (GILD) announced Tuesday positive results from a Phase 3 study in people with primary biliary cholangitis (PBC), showing that treatment with Livdelzi (seladelpar) led to significantly more patients achieving normalization of alkaline phosphatase (ALP).

ALP is a key liver marker of disease progression, compared with placebo after 52 weeks. The primary endpoint was defined as a composite of alkaline phosphatase (ALP) less than or equal to 1.0× upper limit of normal (ULN) and a decrease of at least 15% from baseline.

These findings were observed in people with inadequately controlled disease, defined as having ALP levels above the ULN and below 1.67×ULN, with an incomplete response or intolerance to ursodeoxycholic acid (UDCA).

The safety profile of seladelpar observed in IDEAL was consistent with previously reported Livdelzi studies, with no new safety concerns identified.

In PBC, ALP is a key disease marker associated with disease activity and long-term outcomes. ALP levels above normal, including in the 1.0 to 1.67×ULN range, are associated with increased risk of progression to liver transplant or death compared with normalized ALP levels.

Correction Note: Removes and explains special characters that appeared in the earlier story.

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Global Economics Weekly Update - Jun 01 - Jun 05, 2026

June 05, 2026 16:18 ET
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