Last updated: 03/24/2026 18:00:31

A study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of Efimosfermin alfa administered as a single dose to healthy participants of Chinese, Japanese, and White/European ancestry

GSK study ID
301158
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
Trial description: This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary 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 12 Lead electrocardiogram (ECG)

Timeframe: Up to 90 days

Number of participants with clinically significant changes in vital signs

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

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

Timeframe: Up to 90 days

Maximum observed serum drug concentration, determined directly from the serum concentration-time data (Cmax) of efimosfermin alfa

Timeframe: Up to 90 days

Secondary outcomes:

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

Area under the serum drug concentration versus time curve from time zero to 90 days [AUC(0-90days)] of efimosfermin alfa

Timeframe: Up to 90 days

Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa

Timeframe: Up to 90 days

Apparent clearance (CL/F) of efimosfermin alfa

Timeframe: Up to 90 days

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

Timeframe: Up to 90 days

Apparent terminal phase elimination rate constant (Lambda_z) of efimosfermin alfa

Timeframe: Up to 90 days

Interventions:
  • Drug: Efimosfermin alfa
  • Drug: Placebo
  • Enrollment:
    30
    Observational study model:
    Not applicable
    Primary completion date:
    2026-17-08
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Non-alcoholic Fatty Liver Disease
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    March 2026 to August 2026
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 Years
    Accepts healthy volunteers
    Yes
    • Participants who are generally healthy as determined by medical evaluation
    • Body weight at least 50.0 Kilogram (kg) for male participants or at least 45.0 kg for female participants
    • History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
    • Current or chronic history of liver or biliary disease with the exception of Gilbert’s syndrome or asymptomatic gallstones.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Auckland, Unmapped, 1010
    Status
    Recruiting

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website