A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease
GlaxoSmithKline
Summary
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Between 18 years and 70 years of age inclusive * Body Mass Index (BMI) within the range 23 - 40 kilogram per square meter (kg/m\^2) * Male or female participants * Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must: * Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and * Be classed during Screening as one of the following Child-Pugh classes: * Child-Pu…
Interventions
- DrugEfimosfermin alfa
Efimosfermin alfa to be administrated subcutaneously
Locations (3)
- GSK Investigational SiteRialto, California
- GSK Investigational SiteTampa, Florida
- GSK Investigational SiteSan Antonio, Texas