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NCT04950127 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
238
Enrollment target

NCT04950127: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT04950127 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 238 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04950127, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
238 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Linerixibat

Trial Details

FieldValue
Enrollment Target 238 participants
Start Date 2021-08-27
Est. Completion 2024-12-20
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT04950127 record still lists

NCT04950127 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04950127 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04950127 about?

NCT04950127 is a clinical study titled "Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)". 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.

What is the current status of trial NCT04950127?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2021-08-27. Estimated completion is 2024-12-20.

What interventions are being tested in trial NCT04950127?

The interventions under investigation include: Placebo (DRUG), Linerixibat (DRUG).

Who is sponsoring clinical trial NCT04950127?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04950127's enrollment target sits among peer trials

238 1291st of 2000 higher than 708 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04950127, the US trial registry maintained by the National Library of Medicine. NCT04950127 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.