Last updated: 01/27/2026 06:50:45

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment

GSK study ID
306836
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: Up to 90 Days

Maximum observed serum drug concentration (Cmax) of efimosfermin alfa

Timeframe: Up to 90 Days

Secondary outcomes:

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

Timeframe: Up to 90 Days

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

Timeframe: Up to 90 Days

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

Timeframe: Up to 90 Days

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

Timeframe: Up to 90 Days

Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa

Timeframe: Up to 90 Days

Apparent terminal phase half-life (t1/2) of efimosfermin alfa

Timeframe: Up to 90 Days

Time prior to the first measurable (non-zero) serum concentration (Tlag) of efimosfermin alfa

Timeframe: Up to 90 Days

Apparent clearance (CL/F) of efimosfermin alfa

Timeframe: Up to 90 days

Apparent terminal phase volume of distribution (Vz/F) of efimosfermin alfa

Timeframe: Up to 90 days

Terminal elimination rate constant (Lambda z) of efimosfermin alfa

Timeframe: Up to 90 days

Interventions:
  • Drug: Efimosfermin alfa
  • Enrollment:
    32
    Primary completion date:
    2027-20-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Non-alcoholic Fatty Liver Disease
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    February 2026 to September 2027
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 Years
    Accepts healthy volunteers
    No
    • 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)
    • History of extrahepatic disorders possibly related to etiology of cirrhosis.
    • History of cryoglobulinemia.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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