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Phase 2b Study of GSK4532990 in Adults With NASH

Active Not RecruitingPhase 2

Sponsor: GlaxoSmithKline

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

Interventions: GSK4532990, Placebo

Countries: United States, Argentina, Australia, Belgium, Canada, France, Greece, India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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. 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.

Locations (170)

Homewood, Alabama, United States
Chandler, Arizona, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Jonesboro, Arkansas, United States
North Little Rock, Arkansas, United States
Huntington Park, California, United States
La Jolla, California, United States
Orange, California, United States
Poway, California, United States
Rialto, California, United States
Sacramento, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Van Nuys, California, United States
Colorado Springs, Colorado, United States
Bradenton, Florida, United States
Coral Gables, Florida, United States
Fort Myers, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Jupiter, Florida, United States
Lakewood Rch, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
West Palm Beach, Florida, United States
Athens, Georgia, United States
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