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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06613698




Registration number
NCT06613698
Ethics application status
Date submitted
23/09/2024
Date registered
26/09/2024

Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease
Scientific title
A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults With Alcohol-related Liver Disease (ALD)
Secondary ID [1] 0 0
2024-511596-15
Secondary ID [2] 0 0
222291
Universal Trial Number (UTN)
Trial acronym
STARLIGHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Diseases, Alcoholic 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK4532990
Treatment: Drugs - Placebo

Experimental: GSK4532990 Dose 1 -

Experimental: GSK4532990 Dose 2 -

Experimental: GSK4532990 Dose 3 -

Experimental: GSK4532990 Dose 4 -

Placebo comparator: Placebo -


Treatment: Drugs: GSK4532990
GSK4532990 will be administered

Treatment: Drugs: Placebo
Placebo will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
Up to 8 weeks
Primary outcome [2] 0 0
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests
Timepoint [2] 0 0
Up to 8 weeks
Primary outcome [3] 0 0
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 28 (kiloPascal)
Timepoint [3] 0 0
Baseline (Day 1) and up to Week 28
Primary outcome [4] 0 0
Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 28
Timepoint [4] 0 0
Baseline (Day 1) and up to Week 28
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax) of GSK4532990
Timepoint [1] 0 0
Up to Day 4
Secondary outcome [2] 0 0
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Timepoint [2] 0 0
Up to Day 4
Secondary outcome [3] 0 0
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Timepoint [3] 0 0
Up to 24 hours
Secondary outcome [4] 0 0
Plasma half-life (t1/2) of GSK4532990
Timepoint [4] 0 0
Up to Day 4
Secondary outcome [5] 0 0
Apparent clearance (CL/F) of GSK4532990
Timepoint [5] 0 0
Up to Day 4
Secondary outcome [6] 0 0
Time to maximum concentration (tmax) of GSK4532990
Timepoint [6] 0 0
Up to Day 4
Secondary outcome [7] 0 0
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Timepoint [7] 0 0
Up to Day 4
Secondary outcome [8] 0 0
Change from baseline in serum AST at Week 28
Timepoint [8] 0 0
Baseline (Day 1), and at Week28
Secondary outcome [9] 0 0
Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 28
Timepoint [9] 0 0
Baseline (Day 1), and at Week 28
Secondary outcome [10] 0 0
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Timepoint [10] 0 0
Up to Day 3
Secondary outcome [11] 0 0
Maximum observed plasma concentration (Cmax) of GSK4532990
Timepoint [11] 0 0
Up to Day 3

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent prior to the performance of any study-specific procedures.
* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
* In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.
* A female participant is eligible to participate after meeting additional pre-defined criteria.
* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
* Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
* Current or ongoing malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
* Prior liver transplant or current listing for liver transplant during the screening period.
* Chronic or acute, including partial, known portal vein thrombosis.
* Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
* Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
* Poorly controlled hypertension
* Clinical suspicion of rhabdomyolysis during the screening period
* Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
* Body Mass Index (BMI) >35 kg/m2 at screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
27/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/03/2027
Actual
Sample size
Target
393
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [2] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [3] 0 0
GSK Investigational Site - Perth
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Parkville Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Canada
State/province [15] 0 0
Terrebonne
Country [16] 0 0
Denmark
State/province [16] 0 0
Esbjerg
Country [17] 0 0
Denmark
State/province [17] 0 0
Odense C
Country [18] 0 0
France
State/province [18] 0 0
Angers Cedex 9
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France
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Bobigny cedex
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France
State/province [20] 0 0
CrEteil Cedex
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Rouen cedex
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Kiel
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Italy
State/province [26] 0 0
Bergamo
Country [27] 0 0
Italy
State/province [27] 0 0
Bologna
Country [28] 0 0
Italy
State/province [28] 0 0
Messina
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Italy
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Milano
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Italy
State/province [30] 0 0
Padova
Country [31] 0 0
Italy
State/province [31] 0 0
Roma
Country [32] 0 0
Japan
State/province [32] 0 0
Chiba
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Japan
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Gunma
Country [34] 0 0
Japan
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Kagawa
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Japan
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Nara
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Ansan
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon Gyeonggi-do
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Mexico
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Acapulgo
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Mexico
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Ciudad de Mexico
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Mexico
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DF
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Spain
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Barcelona
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Spain
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Leon
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Spain
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Madrid
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Sweden
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Stockholm
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Sweden
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Uppsala
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
State/province [57] 0 0
Glasgow Strathclyde
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United Kingdom
State/province [58] 0 0
Leeds West Yorkshire
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Liverpool
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United Kingdom
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London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06613698