Phase 2b Study of GSK4532990 in Adults With NASH

• Status: Not yet recruiting
• Trial end date: 2025-03-11
• Target enrollment: 0
• Participant gender: All

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 (F3) fibrosis. The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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.

• A liver biopsy at baseline showing NAFLD Activity Score (NAS) >=4 with at least 1 point each in steatosis, inflammation and ballooning and Fibrosis CRN score of 3.

• Able and willing to comply with all study assessments, including a liver biopsy at Week 52.

Exclusion Criteria:

• Cirrhosis (based on screening biopsy or historical biopsy showing definitive cirrhosis).

• 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 (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1.

• History of cancer within previous 2 years from Screening 1, except adequately resected non-melanoma skin cancer.