Phase 2b Study of GSK4532990 in Adults With NASH (HORIZON)
N
Niharika Samala, MD
Primary Investigator
Enrolling By Invitation
18-75 years
All
Phase
2
246 participants needed
1 Location
Brief description of study
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. Theudy duration will be up to 76 weeks including the screening period. The treatment duration
will be up to 52 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Nonalcoholic Fatty Liver Disease
-
Age: Between 18 Years - 75 Years
-
Gender: All
Inclusion Criteria:
- Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m^2) (all ethnic origins)Asian participants who qualify for the study with BMI ≥23 kg/m2 atg.
- In the opinion of the investigator, there are features of metabolic syndrome and NAFLDhe most likely cause of liver disease. Metabolic syndrome may include type 2diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension.
- A liver biopsy at baseline showing NAFLD Activity Score (NAS) >=4 with at least 1h in steatosis, inflammation and ballooning and Fibrosis CRN score of 3.
- Able and willing to comply with all study assessments, including a liver biopsy atWeek 52.
Exclusion Criteria:
- Cirrhosis (based on screening biopsy or historical biopsy showing definitivehosis).
- Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for≥21 standard drinks (37 units, 294g ethanol) per week for males.
- Weight reduction surgery (including gastric banding and intragastric balloon) within 2 years of Screening 1.
- History of cancer within previous 2 years from Screening 1, except adequately resectedkin cancer.
Updated on
01 Aug 2024.
Study ID: 218672
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