Last updated: 06/05/2026 12:20:34

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
Recruiting
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
Observational study model:
Not applicable
Primary completion date:
2027-13-10
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 October 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)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
San Antonio, TX, Unmapped, 78215
Status
Recruiting
Location
GSK Investigational Site
Rialto, CA, Unmapped, 92377
Status
Recruiting
Location
GSK Investigational Site
Tampa, FL, Unmapped, 33603
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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