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What’s the trial about? 

The GLISTEN trial is designed to assess whether an investigational medication called linerixibat improves primary biliary cholangitis (PBC) itch over a number of months. This will be done using specially designed rating scales and scoring tools completed by participants.

The trial will also look at the effect of linerixibat on quality of life, including sleep and mood.

The trial comes off the back of the GLIMMER trial, a phase IIb trial studying linerixibat. The results showed that with some doses tested, the itch intensity significantly diminished. Some participants also showed improvements in other aspects of quality of life.

The GLIMMER trial also helped identify a dose of linerixibat for future use in the GLISTEN trial.

Why is it needed?

PBC itch is a condition in desperate need of better treatments, so clinical research specifically focused on this is an important priority.

The exact cause of itching in people with PBC isn’t fully understood, but it has long been suspected that the build-up of bile acids in the bloodstream plays a part.

Many people with PBC itch feel that current treatments are not good enough. Clinical research is the only route to proven new treatments and is the reason for the GLISTEN trial. 

Who is eligible to join?

The GLISTEN trial is open to people aged 18–80 across several countries who have been diagnosed with PBC and have moderate-to-severe itch.

If you have certain other conditions, it may not be possible for you to join. You also won’t be able to take part if you are pregnant, breastfeeding or planning a pregnancy.

Go to the online pre-screener and see whether the trial seems suitable for you.

For further information on the GLISTEN trial please visit: https://www.glistentrial.com/gb-en