Phase 2b Study of GSK4532990 in Adults with NASH
- Conditions
- on-Alcoholic Steatohepatitis
- Registration Number
- JPRN-jRCT2041220100
- Lead Sponsor
- Okawa Yasutoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 246
Body Mass Index (BMI) >-25 kilogram per meter square (kg/m2) (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.
- 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, 294 g 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method