Phase 2b Study of GSK4532990 in Adults With NASH (HORIZON)

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver Disease

Treatments: Drug: GSK4532990; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05583344

218672

2022-002538-14 (EudraCT Number)

2023-507503-62-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 3 patient groups, including a placebo group

High Dose GSK4532990

Experimental group

Treatment:

Drug: GSK4532990

Low Dose GSK4532990

Experimental group

Treatment:

Drug: GSK4532990

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo