NCT07358546 · GlaxoSmithKline
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
What this study is about
This study is designed to study the how the drug moves through the body (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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Participants must:
- 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
- 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 (greater than \[\>\] 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.
Exclusion criteria
- History of extrahepatic disorders possibly related to etiology of cirrhosis.
- History of cryoglobulinemia.
- Participants with Grade 3 ascites or refractory ascites.
- 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 treated with medication and/or surgical procedures.
- 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.
- History of pancreatic injury, pancreatitis, or other pancreatic disease.
- History of liver transplantation, or active on the liver transplant waiting list.
- 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-up.
- 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 times (x) upper limit of normal (ULN)
- Participants with Aspartate aminotransferase (AST) value \>=300 Units/Liter.
- Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology \[CKD-Epi\] 2021) \<45 milliliter/minute/1.73 square meter (mL/min/1.73m\^2).
- Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) \>480 milliseconds (msec) (for male and female participants) at Screening
- For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.
Where
- Rialto, California
- Tampa, Florida
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 9, 2026 · Source of record for eligibility and locations