Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-04-13
32
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of a single dose of efimosfermin alfa in adults with varying degrees of hepatic impairment caused by steatotic liver disease, including those with different levels of alcohol consumption. This Phase 1 study focuses on participants classified by Child-Pugh scores to understand how their liver function affects the drug's behavior and safety. All participants will receive one dose of efimosfermin alfa administered under the skin. The study includes groups with moderate hepatic impairment due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with either low or high alcohol use, and a group with severe hepatic impairment regardless of alcohol use. Participants are grouped based on their Child-Pugh classification and alcohol consumption levels prior to screening. Participants will be closely monitored over up to 90 days to measure drug levels in the blood, including the amount and timing of the drug concentration, as well as safety through adverse event tracking and laboratory tests. The study will assess vital signs, heart activity via ECG, and clinical lab results to evaluate any effects from the drug. This monitoring helps researchers understand how efimosfermin alfa behaves and its safety profile in people with different liver impairments.
CONDITIONS
Brief 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
- Clinical diagnosis of liver cirrhosis confirmed by biopsy, imaging, or biochemical profile
- Classified as Child-Pugh B (score 7-9) or Child-Pugh C (score 10-15) during screening
- Chronic hepatic impairment longer than 6 months, stable with no acute illness in the last month and during screening
You will not qualify if you...
- History of extrahepatic disorders related to cirrhosis cause
- History of cryoglobulinemia
- Grade 3 or refractory ascites
- Refractory encephalopathy or significant central nervous system disease
- Recent gastric or esophageal variceal bleeding within 6 months without adequate treatment
- Other primary liver diseases besides steatotic liver disease
- Significant health abnormalities posing risk or interfering with study
- Current or past 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 or disease
- History of liver transplantation or active transplant waiting list
- Signs of active infection
- Adrenal gland disease or use of treatments affecting hypothalamic-pituitary-adrenal axis
- Significant bone disease such as osteoporosis
- Psychosocial issues increasing risk of loss to follow-up
- History or presence of drug abuse
- Use of other investigational drugs close to screening
- Previous use of efimosfermin alfa
- Alanine Aminotransferase (ALT) greater than 3 times upper limit of normal
- Aspartate aminotransferase (AST) equal or above 300 Units/Liter
- Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m^2
- Average corrected QT interval (QTc) above 480 ms or bundle branch block
- Significant risk of withdrawal symptoms for participants with alcohol use in MASH group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 90 days
Participants receive a single subcutaneous dose of efimosfermin alfa to evaluate its pharmacokinetics and safety.
Multiple visits over 90 days for monitoring and assessments
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
E
EU GSK Clinical Trials Call Center
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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