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STARLIGHTNCT06613698

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary endpoint(s) modified, enrollment reduced 11%.

See at-risk trials from GlaxoSmithKline

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Enrollment reduced: 393 → 350 participants
    • Trial sites expanded: 140 → 150 locations
    • Study completion pushed from Mar 7, 2028 to Mar 2, 2029
    • Secondary endpoints: 11 to 13
  2. Primary completion pushed from Aug 2, 2027 to Nov 26, 2027
    • Trial sites expanded: 131 → 140 locations
    v6
  3. Primary endpoint(s) modifiedv5 Show 5 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Trial sites expanded: 123 → 131 locations
    • Study completion date: Mar 30, 2028 to Mar 7, 2028
    • Secondary endpoints revised (11)
    • Study title revised
  4. Primary completion date: Dec 8, 2026 to Aug 2, 2027
    • Study sites: 26 to 123
    • Study completion date: Aug 23, 2027 to Mar 30, 2028
    v4
  5. Eligibility criteria expanded, about 18 words
    • Site details revised at 1 of 26 sites
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 81 to 26
    • Primary completion date: Dec 1, 2026 to Dec 8, 2026
    • Study completion date: Mar 10, 2027 to Aug 23, 2027
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 8 weeks
Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests.
Timeframe: Up to 8 weeks
Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal)
Timeframe: Baseline (Day 1) and at Week 52

Secondary (13)

Maximum plasma concentration (Cmax) of GSK4532990
Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990
Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990
Plasma half-life (t1/2) of GSK4532990
Apparent clearance (CL/F) of GSK4532990
Show 8 moreShow less
Time to maximum concentration (tmax) of GSK4532990
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Change from baseline in serum AST at Week 52
Change from baseline in Enhanced Liver Fibrosis (ELFTM) score at Week 52
Change from baseline in model for end-stage liver disease (MELD) score at Week 52
Change from baseline in LSM using FibroScan® at Week 52 (kiloPascal)
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Maximum observed plasma concentration (Cmax) of GSK4532990

Arms and interventions

GSK4532990 Dose 1Experimental
GSK4532990 Dose 2Experimental
GSK4532990 Dose 3Experimental
GSK4532990 Dose 4Experimental
PlaceboPlacebo comparator

Drugs: GSK4532990, Placebo

Sites

150 sites in 19 countries

United States 34, Spain 16, Japan 14, Argentina 9, Canada 9, Italy 9, United Kingdom 9, Germany 8, South Korea 8, France 6, Australia 5, Turkey (Türkiye) 4, Denmark 3, Greece 3, Mexico 3, Poland 3, Thailand 3, South Africa 2, Sweden 2