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

Phase 2

Recruiting

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: GSK4532990

• Registration Number: NCT06104319
• Lead Sponsor: GlaxoSmithKline

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 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Study Start: 2024-01-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-06-27
• Study Completion: 2025-06-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

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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®.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GSK4532990 Dose 2	GSK4532990	Participants will receive GSK4532990 Dose 2
GSK4532990 Dose 3	GSK4532990	Participants will receive GSK4532990 Dose 3
GSK4532990 Dose 4	GSK4532990	Participants will receive GSK4532990 Dose 4
GSK4532990 Dose 1	GSK4532990	Participants will receive GSK4532990 Dose 1

Primary Outcome Measures

Name	Time	Method
Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels	Baseline (Day 1) and up to Week 16
Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels	Baseline (Day 1) and up to Week 16

Secondary Outcome Measures

Name	Time	Method
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
Percent change from baseline in the observed HSD17B13 protein expression levels	Baseline and Weeks 8, 12, or 16 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 mRNA expression levels	Baseline and Weeks 8, 12, or 16 post-dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 San Antonio, Texas, United States