RecruitingNon-alcoholic Fatty Liver Disease

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Eligible age

18–75 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ 1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
✓ 2. Age \>=18 and \<=75 years at enrollment
✓ 3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
✓ 4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist

You may not qualify if…

✕ 1. Contraindication or ineligibility for percutaneous liver biopsy
✕ 2. ALT or AST \>=5 x upper limit of normal (ULN)
✕ 3. Total bilirubin \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of \>=1.3 mg/dL and direct bilirubin is \<=20% of total bilirubin; otherwise, the individual will be excluded.
✕ 4. Serum albumin \<=3.5 grams per deciliter (g/dL)
✕ 5. International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
✕ 6. Alkaline phosphatase (ALP) \>=2\*ULN
✕ 7. Platelet (PLT) count \<140,000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor.
✕ 8. Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation