Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency

Inclusion criteria

• Willing to participate in the study and provide written informed consent
• Male and female adults aged > 18 years
• Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
• Liver Frailty Index (LFI) of ≥3.6
• Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week

Exclusion criteria

• Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
• Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
• Current or history of significant alcohol consumption
• Other poorly controlled medical condition [e.g., renal disease with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2)
• Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
• Any extreme or unbalanced diet such as Ketogenic, Atkins, Paleo, Vegan, etc.
• Unable or unwilling to adhere to contraception requirements
• Any contraindications to a MRI scan
• Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion