RecruitingNon-alcoholic Fatty Liver Disease

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

Eligible age

18–75 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
✓ Age \>=18 through \<=75 years at enrolment
✓ History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
✓ History or presence of known or suspected MASH with evidence of fibrosis

You may not qualify if…

✕ ALT or AST \>=5 × upper limit of normal (ULN)
✕ Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded.
✕ Serum albumin \<=3.5 grams per deciliter (g/dL)
✕ 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.
✕ Alkaline phosphatase (ALP) \>=2 × ULN
✕ 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
✕ 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.
✕ Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)