Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)

This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.

Inclusion Criteria:

• Willing to participate in the study and provide written informed consent.
• Male and female adults aged ≥18 years.
• History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
• A PHES of ≤ -4 during Screening.
• MELD score of ≤ 22 at Screening.
• Support of a primary caregiver who is able and willing to give written informed consent.

Exclusion Criteria:

• Hospitalization or serious medical condition.
• Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
• History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
• Expectation of a liver transplant during the study.
• Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.