Study of Efimosfermin Alfa for Liver Impairment
This study is looking at a drug called efimosfermin alfa in adults with liver impairment (hepatic impairment). The goal is to understand how the body processes this drug (pharmacokinetics or PK) and to check its safety after a single dose. You might be able to join if you are between 18 and 70 years old, have a BMI between 23 and 40, and have liver cirrhosis with a specific Child-Pugh score, which measures how well your liver is working. The study aims to enroll 32 participants. Researchers will measure the drug levels in your blood for up to 90 days to see how it's absorbed and cleared by your body.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 32 participants to study the drug's effects.
- What's involved
- Participants will receive a single dose of efimosfermin alfa. Blood samples will be taken to measure drug levels for up to 90 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 90 days to measure drug concentrations.
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NCT07358546
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Recruiting
PHASE1Ages 18–70InterventionalTreatmentGlaxoSmithKline
~32 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Efimosfermin alfa
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
Measured over Up to 90 Days
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesCalifornia1
Florida1
Texas1
Study leadership
- GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfaUp to 90 Days
- Maximum observed serum drug concentration (Cmax) of efimosfermin alfaUp to 90 Days