Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

Summary

This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

Timeline

Start

2021-08-27

Primary completion

2024-10-28

Completion

2024-12-20

Publications

• Hirschfield GM, Bowlus CL, Jones DEJ, Kremer AE, Mayo MJ, Tanaka A, Andreone P, Jia J, Jin Q, Macias-Rodriguez RU, Cobitz AR, Currie BM, Gorey C, Lazic I, Podmore D, Ribeiro A, Shannon JB, Swift B, McLaughlin MM, Levy C; GLISTEN Study Group. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):22-33. doi: 10.1016/S2468-1253(25)00192-X. Epub 2025 Oct 28.
• Carreno F, Karatza E, Mehta R, Collins J, Austin D, Swift B. Population Dose-Response-Time Analysis of Itch Reduction and Patient-Reported Tolerability Supports Phase III Dose Selection for Linerixibat. Clin Pharmacol Ther. 2024 Feb;115(2):288-298. doi: 10.1002/cpt.3103. Epub 2023 Dec 3.

Drugs

Indications

No indication recorded.