drugset / Trial / NCT04950127
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
RandomizedParallel-groupDouble-blindTreatment
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
Outcome
Met primary endpoint
registry analysis (superiority test); Part A: Linerixibat 40 Milligrams (mg) vs Part A: Placebo; p = 0.001; Mean Difference (Net) -0.72 (95% CI -1.15 to -0.28) NCT04950127 ↗
paper Patients receiving linerixibat experienced significant improvement in pruritus over 24 weeks compared with placebo PMID 41173016 ↗
release “GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in itch” gsk.com ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linerixibat | Small molecule | 40 mg | Oral |
Indications
No indication recorded.