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Clinical Trials in Mexico / NCT05583344
Active, not recruiting Phase 2

Phase 2b Study of GSK4532990 in Adults With NASH

NCT05583344 · tracked via the Priya Life Science Mexico 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)

GSK4532990 →Placebo

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
No
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)

FacilityCityRegionStatus
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.

More GlaxoSmithKline trials in Mexico

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM Active, not recruiting
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults Active, not recruiting
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2) Recruiting
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age Recruiting
An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study Active, not recruiting

Other trials for the same condition

Fibrosis Lessens After Metabolic Surgery Recruiting
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 Mexico