Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Efimosfermin alfa

    Drug

    Efimosfermin alfa to be administrated subcutaneously

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcoholExperimental treatment 1 intervention
Group B: Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcoholExperimental treatment 1 intervention
Group C: Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol useExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa

Time frame
Up to 90 Days
2

Maximum observed serum drug concentration (Cmax) of efimosfermin alfa

Time frame
Up to 90 Days

Secondary outcomes

1

Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)

Time frame
Up to 90 Days
2

Number of participants with clinically significant changes in hematology, chemistry, and urinalysis parameters

Time frame
Up to 90 Days
3

Number of participants with clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings

Time frame
Up to 90 Days
4

Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa

Time frame
Up to 90 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov
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