Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06104319

Acronym

SKYLINE

Enrollment

Registered

2023-10-27

Start date

2024-01-22

Completion date

2025-09-23

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

GSK4532990, Non-alcoholic steatohepatitis (NASH), Non-alcoholic fatty liver disease (NAFLD), Suspected NASH

Brief summary

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.

Interventions

DRUGGSK4532990

GSK4532990 will be administered

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels	Baseline (Day 1) and up to Week 28
Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels	Baseline (Day 1) and up to Week 28

Secondary

Measure	Time frame
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990	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	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	Baseline and Weeks 8, 12, or 28 post-dose
Percent change from baseline in the. observed HSD17B13 mRNA expression. levels	Baseline and Weeks 8, 12, or 28 post-dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026