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OpenTrials
Completed

NCT Number: NCT06104319

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®.

Treatment and study plan

GSK4532990

Drug

GSK4532990 will be administered

Primary outcomes

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

    Time frame: Baseline (Day 1) and up to Week 28

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

    Time frame: Baseline (Day 1) and up to Week 28

Secondary outcomes

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

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

  2. Maximum observed concentration (Cmax) of GSK4532990

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: SKYLINE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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