Phase 2b Study of GSK4532990 in Adults With NASH

NCT05583344 · tracked via the Priya Life Science UK tracker

Sponsor

GlaxoSmithKline

Phase

Phase 2

Started

2023-01-02

Last updated

2026-09-18

Condition(s) studied

Nonalcoholic Fatty Liver DiseaseNon-alcoholic Fatty Liver Disease

Investigational drug(s) / intervention(s)

GSK4532990Placebo

GSK4532990: GSK4532990 will be administered.

Placebo: Placebo will be administered.

Study summary

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m\^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m2 at Screening. * In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension. * A liver biopsy at baseline showing NAFLD Activity Score (NAS) \>=4 with at least 1 point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis 4 using NASH CRN Scoring System. * Able and willing to comply with all study assessments, including a liver biopsy at Week 52. Exclusion Criteria: * Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males. * Weight reduction surgery or procedures (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1 and/or planned during the study. * History of cancer within previous 2 years from Screening 1, except basal or squamous cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer which has been treated medically or surgically with curative outcome.

Primary outcome measure(s)

Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - F3 Cohort — At Week 52
Improvement in histological fibrosis is assessed with Clinical research network (CRN) Scoring. No worsening of NASH is defined as no increase in the NAFLD Activity Score (NAS) for steatosis, ballooning, or inflammation.
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - F3 Cohort — At Week 52
NASH resolution is defined as a ballooning score of 0 and an inflammation score of 0-1. No worsening of fibrosis is defined as no increase in CRN fibrosis score.

Trial sites (170)

Facility	City	Region
GSK Investigational Site	Homewood	Alabama
GSK Investigational Site	Chandler	Arizona
GSK Investigational Site	Chandler	Arizona
GSK Investigational Site	Mesa	Arizona
GSK Investigational Site	Jonesboro	Arkansas
GSK Investigational Site	North Little Rock	Arkansas
GSK Investigational Site	Huntington Park	California
GSK Investigational Site	La Jolla	California
GSK Investigational Site	Orange	California
GSK Investigational Site	Poway	California
GSK Investigational Site	Rialto	California
GSK Investigational Site	Sacramento	California
GSK Investigational Site	San Francisco	California
GSK Investigational Site	Santa Ana	California
GSK Investigational Site	Van Nuys	California
GSK Investigational Site	Colorado Springs	Colorado
GSK Investigational Site	Bradenton	Florida
GSK Investigational Site	Coral Gables	Florida
GSK Investigational Site	Fort Myers	Florida
GSK Investigational Site	Hallandale	Florida
GSK Investigational Site	Hialeah	Florida
GSK Investigational Site	Homestead	Florida
GSK Investigational Site	Jupiter	Florida
GSK Investigational Site	Lakewood Rch	Florida
GSK Investigational Site	Miami	Florida
GSK Investigational Site	Miami	Florida
GSK Investigational Site	Miami	Florida
GSK Investigational Site	Miami Lakes	Florida
GSK Investigational Site	West Palm Beach	Florida
GSK Investigational Site	Athens	Georgia
GSK Investigational Site	Atlanta	Georgia
GSK Investigational Site	Marietta	Georgia
GSK Investigational Site	Snellville	Georgia
GSK Investigational Site	Indianapolis	Indiana
GSK Investigational Site	South Bend	Indiana
GSK Investigational Site	Iowa City	Iowa
GSK Investigational Site	Topeka	Kansas
GSK Investigational Site	Bastrop	Louisiana
GSK Investigational Site	Marrero	Louisiana
GSK Investigational Site	Metairie	Louisiana

+ 130 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05583344 on ClinicalTrials.gov ↗ ← All trials in the UK