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Recruiting Phase 1 NCT07358546

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

Trial Parameters

Condition Non-alcoholic Fatty Liver Disease
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 32
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2026-03-13
Completion 2027-10-13
Interventions
Efimosfermin alfa

Brief 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 Criteria

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-Pugh B: Score 7-9 or * Child-Pugh C: Score 10-15 * Chronic (\>6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator. Exclus

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