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CholestasisPhase 3LLSATNCT04167358

Linerixibat Long-term Safety, and Tolerability Study

A Phase 3 study testing Linerixibat in people with Cholestasis, run by GlaxoSmithKline at 94 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cholestasis
What is being tested?
Linerixibat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
94 sitesin 17 countries
Study dates
14 Jul 2020to 30 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.
  • Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
  • Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method.
  • Capable of giving signed informed consent.

Who cannot join

  • Screening total bilirubin >2x upper limit of normal (ULN).
  • Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
  • Screening estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
  • Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B [HBV], viral Hepatitis C [HCV]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
  • Current clinically significant diarrhea in the Investigator's medical opinion.
Show all 14Show fewer
  • Current symptomatic cholelithiasis or cholecystitis.
  • Current diagnosis or previous diagnosis of colorectal cancer.
  • Any current malignancies (including hematologic and solid malignancies).
  • History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
  • Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal.
  • Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal.
  • QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
  • Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.

Trial locations and contacts

94 sites in 17 countries.

94 sites in 17 countries

Japan19 sites

  • GSK Investigational Site

    Chiba, 270-1694

  • GSK Investigational Site

    Ehime, 791-0295

  • GSK Investigational Site

    Fukui, 918-8503

  • GSK Investigational Site

    Gunma, 371-8511

  • GSK Investigational Site

    Hiroshima, 730-8619

  • GSK Investigational Site

    Hiroshima, 734-8551

  • GSK Investigational Site

    Hokkaido, 006-8555

  • GSK Investigational Site

    Kagawa, 760-8557

  • GSK Investigational Site

    Kanagawa, 259-1143

  • GSK Investigational Site

    Nagano, 390-8621

  • GSK Investigational Site

    Nagasaki, 856-8562

  • GSK Investigational Site

    Nara, 634-8522

  • GSK Investigational Site

    Osaka, 545-8586

  • GSK Investigational Site

    Osaka, 591-8025

  • GSK Investigational Site

    Shizuoka, 431-3192

  • GSK Investigational Site

    Tokyo, 113-8603

  • GSK Investigational Site

    Tokyo, 162-8655

  • GSK Investigational Site

    Tokyo, 173-8606

  • GSK Investigational Site

    Tokyo, 181-8611

Other trials in Japan

United States11 sites

  • GSK Investigational Site

    Dallas, Texas, 75390

  • GSK Investigational Site

    Davis, California, 95817

  • GSK Investigational Site

    Detroit, Michigan, 48377

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Morrisville, North Carolina, 27560

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Seattle, Washington, 98105

  • GSK Investigational Site

    West Hollywood, California, 90048

Other trials in United States

China9 sites

  • GSK Investigational Site

    Beijing, 100032

  • GSK Investigational Site

    Beijing, 100069

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Chongqing, 400042

  • GSK Investigational Site

    Guangzhou, 510630

  • GSK Investigational Site

    Nanchang, 330006

  • GSK Investigational Site

    Nanjing, 210003

  • GSK Investigational Site

    Shanghai, 200127

  • GSK Investigational Site

    Tianjin, 300000

Other trials in China

United Kingdom9 sites

  • GSK Investigational Site

    Basingstoke, RG24 9NA

  • GSK Investigational Site

    Glasgow, G31 2ER

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    Newcastle upon Tyne, NE4 5PL

  • GSK Investigational Site

    Nottingham, NG7 2UH

  • GSK Investigational Site

    Plymouth, PL6 8DH

  • GSK Investigational Site

    Reading Berkshire, RG1 5AN

  • GSK Investigational Site

    Southampton, SO16 6YD

  • GSK Investigational Site

    Surrey, RH1 5RH

Other trials in United Kingdom

Italy8 sites

  • GSK Investigational Site

    Milan, 20142

  • GSK Investigational Site

    Modena, 41126

  • GSK Investigational Site

    Monza, 20900

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Negrar Verona, 37024

  • GSK Investigational Site

    Padova, 35128

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Roma, 00168

Other trials in Italy

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, C1061AAS

  • GSK Investigational Site

    Capital Federal, C1181ACI

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABI

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, 1118

  • GSK Investigational Site

    Rosario, S2002KDT

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

Poland5 sites

  • GSK Investigational Site

    Częstochowa, 42-217

  • GSK Investigational Site

    Katowice, 40-659

  • GSK Investigational Site

    Mysłowice, 41-400

  • GSK Investigational Site

    Warsaw, 03-712

  • GSK Investigational Site

    Wroclaw, 51-162

Other trials in Poland

Spain5 sites

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

Brazil4 sites

  • GSK Investigational Site

    Botucatu, 18618686

  • GSK Investigational Site

    Brasília, 70335-900

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035003

  • GSK Investigational Site

    Salvador, 40110-160

Other trials in Brazil

Israel4 sites

  • GSK Investigational Site

    Haifa, 34362

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Rehovot, 76100

Other trials in Israel

Mexico3 sites

  • GSK Investigational Site

    Mexico City, 06700

  • GSK Investigational Site

    Mexico City, 14080

  • GSK Investigational Site

    Monterrey, 64020

Other trials in Mexico

Russia3 sites

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Moscow, 119121

  • GSK Investigational Site

    Samara, 443063

Other trials in Russia

Canada2 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2X8

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Czechia2 sites

  • GSK Investigational Site

    Pilsen, 30100

  • GSK Investigational Site

    Prague, 140 21

Other trials in Czechia

Germany2 sites

  • GSK Investigational Site

    Erlangen, 91054

  • GSK Investigational Site

    Münster, 48149

Other trials in Germany

Bulgaria1 site

  • GSK Investigational Site

    Sofia, 1618

Other trials in Bulgaria

France1 site

  • GSK Investigational Site

    Lille, 59037

Other trials in France

About this study

Official title: Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

Conditions
Cholestasis
Being tested
Linerixibat
Keywords
Linerixibat, Cholestasis, Cholestatic pruritus, Primary biliary cholangitis, LLSAT
Medical subject headings
Cholestasis, Liver Cirrhosis, Biliary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinerixibatDrug

    All participants will receive linerixibat.

Study groups in NCT04167358
Study groupRoleWhat they receive
Participants receiving linerixibatExperimentalParticipants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat.
Receives: Drug: Linerixibat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)

    AEs and SAEs will be collected.

    Measured: Up to 66 months

  2. Number of participants with Severe AEs

    AEs and SAEs will be collected.

    Measured: Up to 66 months

Secondary outcomes (9)

  1. Change in domain scores of the PBC-40 over time

    The PBC-40 is a participant-derived, disease specific health-related quality of life (QoL) measure with data to support its validity in PBC. The PBC-40 measure is comprised of 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact) grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional).

    Measured: Baseline and up to 65 months

  2. Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only)

    The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems.

    Measured: Baseline and up to 65 months

  3. Change in self-rated health by EQ VAS scores over time (Group 1 only)

    The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ VAS records self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

    Measured: Baseline and up to 65 months

  4. Change in the Beck Depression Inventory (BDI-II) scores over time

    The BDI-II is a 21-item questionnaire used to assess the intensity of depression in clinical and normal participants. Each item is scored from 0 (Normal) to 3 (Severe). The total score on the BDI-II ranges from 0-63, with higher scores reflecting higher levels of depression.

    Measured: Baseline and up to 65 months

  5. Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters

    Blood samples will be collected for the analysis of hematology, biochemistry (including lipid and liver parameters) and coagulation parameters.

    Measured: Baseline and up to 65 months

  6. Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only)

    Monthly Itch Score (MIS) will be assessed using an numerical rating scale (NRS), ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Response thresholds of greater than or equal to (>=) 2, >=3, and >=4-point reduction in MIS will be assessed.

    Measured: Week 24 and Week 52 of continuous treatment

  7. Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only)

    The MIS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Maintenance of efficacy occurs when a participant is a responder (>=2, >=3, and >=4-point reduction in MIS) at Week 24 of continuous treatment and is also a responder at Week 52 of continuous treatment.

    Measured: Week 52 of continuous treatment

  8. Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)

    The MSS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. This will be assessed at Week 52 of continuous treatment.

    Measured: Baseline and up to Week 52 of continuous treatment

  9. Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)

    The MFS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no fatigue and 10 the worst possible fatigue. This will be assessed at Week 52 of continuous treatment.

    Measured: Baseline and up to Week 52 of continuous treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start14 Jul 2020
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a non-comparator single group study.
Masking
None (open label)
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167358
Sponsor's protocol ID
212358
Other IDs
2019-003158-10, 2019
Acronym
LLSAT
Status last verified
Jun 2026
First submitted
15 Nov 2019
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linerixibat in people with Cholestasis, run by GlaxoSmithKline at 94 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Japan, United States, China, United Kingdom, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs) (time frame: Up to 66 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04167358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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