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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2025-23-09
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 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.
Participant must be 18 to 75 years of age.
Exclusion criteria:
- 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®.
Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
Trial location(s)
Location
GSK Investigational Site
Indianapolis, IN, United States, 46202
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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