A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
ConditionNon-alcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGlaxoSmithKline
About this trial
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
Qualifiers
Between 18 years and 70 years of age inclusive
Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m²)
Male or female participants
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
Disqualifiers
History of extrahepatic disorders possibly related to etiology of cirrhosis.
History of cryoglobulinemia.
Participants with Grade 3 ascites or refractory ascites.
Participants with refractory encephalopathy or significant central nervous system disease
Trial design
Treatments tested in this trial
- Efimosfermin alfa
Treatment groups
32 Participants
are divided into 3 treatment groupsLocations
3GSK Investigational Site92377, RialtoCalifornia, United States
GSK Investigational Site33603, TampaFlorida, United States
GSK Investigational Site78215, San AntonioTexas, United States
Sponsors and collaborators
GlaxoSmithKline
Lead sponsor
Source ClinicalTrials.gov