A Study of Efimosfermin Alfa in Adults With Hepatic Impairment (NCT07358546) | Clinical Trial Compass
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
United States32 participantsStarted 2026-03-13
Plain-language summary
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
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prima…
What they're measuring
1
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
2
Maximum observed serum drug concentration (Cmax) of efimosfermin alfa