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

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.