Last updated: 10/13/2025 13:40:12

Dose Exploration Study of GSK4532990 in. Participants with NASH or Suspected NASHSKYLINE

GSK study ID
218675
Clinicaltrials.gov ID
NCT06104319
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 2a, single dose, open-label, dose exploration study to assess the PK-PD activity, safety, and tolerability of GSK4532990 in adult. participants with NASH or suspected NASH
Trial description: The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels

Timeframe: Baseline (Day 1) and up to Week 28

Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels

Timeframe: Baseline (Day 1) and up to Week 28

Secondary outcomes:

Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990

Timeframe: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose

Maximum observed concentration (Cmax) of GSK4532990

Timeframe: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose

Percent change from baseline in the. observed HSD17B13 protein expression. levels

Timeframe: Baseline and Weeks 8, 12, or 28 post-dose

Percent change from baseline in the. observed HSD17B13 mRNA expression. levels

Timeframe: Baseline and Weeks 8, 12, or 28 post-dose

Interventions:
  • Drug: GSK4532990
    • Enrollment:
    61
    Primary completion date:
    2025-23-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Non-alcoholic Fatty Liver Disease
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    January 2024 to September 2025
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 Years
    Accepts healthy volunteers
    No
    • Participant must be 18 to 75 years of age.
    • Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
    • Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
    • Cirrhosis or current unstable liver or biliary disease.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Participant must be 18 to 75 years of age.

      • Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
      • Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
      • Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
    Exclusion criteria:

      Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:

      • Cirrhosis or current unstable liver or biliary disease.
      • Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.
      • Known weight loss of ≥5% within 3 months prior to Screening.
      • Weight reduction surgery or procedures within 2 years of Screening.
      • Any contraindication to undergoing liver biopsy.
      • Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    AUSTIN, TX, United States, 78745
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, CA, United States, 91911
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    El Dorado, KS, United States, 67042
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Indianapolis, IN, United States, 46202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miami, FL, United States, 33173
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miami, FL, United States, 33155
    Status
    Study Complete
    Contact us
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2025-23-09
    Actual study completion date
    2025-23-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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