Phase 2b Study of GSK4532990 in Adults With NASH

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT05583344

Run by

GlaxoSmithKline

People needed

284

Starts

2023-01-02

Expected to finish

2026-09-23

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Kanagawa, Japan
• GSK Investigational Site — Nagano, Japan
• GSK Investigational Site — Nagasaki, Japan
• GSK Investigational Site — Nara, Japan
• GSK Investigational Site — Numakunai, Japan
• GSK Investigational Site — Okayama, Japan
• GSK Investigational Site — Osaka, Japan
• GSK Investigational Site — Saga, Japan
• GSK Investigational Site — Shimane, Japan
• GSK Investigational Site — Yamanashi, Japan
• GSK Investigational Site — Cuernavaca Morelos, Mexico
• GSK Investigational Site — Guadalajara, Mexico
• GSK Investigational Site — Mérida, Mexico
• GSK Investigational Site — Panama City, Panama
• GSK Investigational Site — Panama City, Panama
• GSK Investigational Site — San Juan, Puerto Rico
• GSK Investigational Site — Incheon, South Korea
• GSK Investigational Site — Seoul, South Korea
• GSK Investigational Site — Seoul, South Korea
• GSK Investigational Site — Yongsan-Ku Seoul, South Korea
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Kanagawa, Japan

Full record on ClinicalTrials.gov

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