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
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