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
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:
Enrollment:
32
Primary completion date:
2027-20-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Body Mass Index (BMI) within the range 23 – 40 kilogram per square meter (kg/m^2)
- Male or female participants
- Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must: o 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 o Be classed during screening as one of the following Child-Pugh classes: -Child-Pugh B: Score 7-9 or -Child-Pugh C: Score 10-15
- Chronic (>6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant’s hepatic function will be determined by the investigator.
Between 18 years and 70 years of age inclusive
Exclusion criteria:
- History of cryoglobulinemia.
- Participants with Grade 3
- Participants with refractory encephalopathy or significant central nervous system disease
- History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately
- Other primary causes of liver disease Steatotic liver disease must be the primary cause of liver disease.
- Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study
- Current, or history of known hepatocellular carcinoma (HCC).
- Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.
- Presence of hepatopulmonary or hepatorenal syndrome.
- Presence of primarily cholestatic liver diseases.
- Evidence of symptomatic or complicated cholecystitis of
- History of pancreatic injury, pancreatitis, or other pancreatic disease.
- History of liver transplantation.
- Participants with signs of active infection
- History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.
- History of significant bone disease such as osteoporosis
- Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-
- History or presence of drug abuse.
- Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations
- Have previously taken efimosfermin alfa
- Participants with Alanine Aminotransferase (ALT) value >3 x upper limit of normal (ULN)
- Average of triplicate corrected QT interval, (QTc) >480 msec in (for male and female participants)participants with bundle branch block at Day -1 (Visit 2) (a mean of triplicate measurements should be used to confirm that the participant meets exclusion criterion).
- For participants in the MASH with alcohol category, significant risk of withdrawal symptoms:
History of extrahepatic disorders possibly related to etiology of cirrhosis.
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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