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

This is an interventional basic science trial for Hepatic Insufficiency focused on measuring Amino acids, food study Read More

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