for people ages 18-80 (full criteria)
at Sacramento, California and other locations
study started
completion around



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.

Official Title

A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)


Pruritus, Cholestasis, GLISTEN, GSK2330672, Itch, Primary biliary cholangitis, Cholangitis, Biliary Liver Cirrhosis, Linerixibat


You can join if…

Open to people ages 18-80

  • Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.
  • Participants who have documented PBC.
  • Participants who have moderate to severe itch.

You CAN'T join if...

  • Total bilirubin >2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures.
  • Screening Alanine Aminotransferase (ALT) > 6 times ULN in a single Baseline measure or ALT > 5 times ULN using the average of two Baseline measures.
  • Screening estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (mL/min/1.73m2).
  • History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites).
  • Presence of HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV and Ribonucleic acid [RNA] detected) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
  • Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator´s clinical judgment.
  • Current symptomatic cholelithiasis or cholecystitis.
  • Current diagnosis of primary skin disorders with itch as a characteristic feature (e.g., atopic dermatitis, psoriasis).
  • Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.
  • Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening.
  • Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study).
  • Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching.
  • Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening.
  • Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study.
  • History of sensitivity or intolerance to the study treatment.


  • GSK Investigational Site
    Sacramento California 95817 United States
  • GSK Investigational Site
    San Francisco California 94143 United States


accepting new patients
Start Date
Completion Date
Sign up for this study
Phase 3 research study
Study Type
About 241 people participating
Last Updated