Phase 1 Study of Efimosfermin Alfa Injection in Adults Aged 18 to 70 With Moderate to Severe Liver Impairment from Fatty Liver Disease

What this Trial Is About

Researchers are evaluating the pharmacokinetic and safety profiles of a single dose of efimosfermin alfa in adults with different levels of liver impairment caused by steatotic liver disease. The study focuses on participants who have hepatic impairment classified by the Child-Pugh score, with or without significant alcohol consumption. This is a phase 1, open-label study assessing efimosfermin alfa in adults aged 18 to 70 with metabolic dysfunction-associated steatohepatitis MASH. All participants will receive a single subcutaneous dose of efimosfermin alfa. The study includes three groups based on the degree of hepatic impairment and alcohol use moderate impairment with low alcohol consumption, moderate impairment with higher alcohol consumption, and severe impairment regardless of alcohol use. The study uses a sequential design to evaluate these groups. Participants will be monitored up to 90 days after dosing. Researchers will measure drug concentration in blood over time and monitor for adverse events, changes in lab results, vital signs, and ECG readings. The main outcomes include drug exposure levels and safety assessments to understand how hepatic impairment affects efimosfermin alfa pharmacokinetics. Participants will have regular assessments during this period to track these outcomes.

A Study of Efimosfermin Alfa in Adults With Hepatic Impairment