Actively Recruiting
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Led by GlaxoSmithKline · Updated on 2026-04-13
32
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Male or female participants
- Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class
- Clinical diagnosis of liver cirrhosis confirmed by biopsy, medical imaging, or compatible biochemical profile
- Classified as Child-Pugh B (score 7-9) or Child-Pugh C (score 10-15) during screening
- Chronic hepatic impairment present for more than 6 months and currently stable with no acute illness episodes within 1 month prior to screening
- Participant must remain stable throughout the screening period
You will not qualify if you...
- History of extrahepatic disorders possibly related to cirrhosis etiology
- History of cryoglobulinemia
- Grade 3 ascites or refractory ascites
- Refractory encephalopathy or significant central nervous system disease
- Gastric or esophageal variceal bleeding within past 6 months without adequate treatment
- Other primary liver diseases; steatotic liver disease must be primary cause
- Clinically significant physical health abnormalities interfering with study conduct or posing unacceptable risk
- Current or history of hepatocellular carcinoma (HCC)
- Transjugular intrahepatic portosystemic shunt (TIPS) placement
- Hepatopulmonary or hepatorenal syndrome
- Primarily cholestatic liver diseases
- Symptomatic or complicated cholecystitis
- History of pancreatic injury, pancreatitis, or other pancreatic disease
- History of liver transplantation or active on liver transplant waiting list
- Signs of active infection
- History of adrenal gland disease or use of treatments affecting hypothalamic-pituitary-adrenal axis
- History of significant bone disease such as osteoporosis
- Psychosocial features increasing likelihood of loss to follow-up
- History or presence of drug abuse
- Use of other investigational drugs within 5 half-lives or 30 days before intervention
- Previous use of efimosfermin alfa
- Alanine Aminotransferase (ALT) value >3 times upper limit of normal
- Aspartate aminotransferase (AST) value ≥300 Units/Liter
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m^2
- Average corrected QT interval (QTc) >480 milliseconds or bundle branch block at screening
- For participants with alcohol-related MASH, significant risk of withdrawal symptoms
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
GSK Investigational Site
Rialto, California, United States, 92377
Actively Recruiting
2
GSK Investigational Site
Tampa, Florida, United States, 33603
Actively Recruiting
3
GSK Investigational Site
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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