Clinical Trials

Inclusion Criteria:

1. Body mass index within the range 18 to 40 kg/m2 (inclusive) at screening.
2. Females must be non-pregnant, non-lactating or of non-childbearing potential or using highly efficient contraception for the full duration of the study.
3. Cirrhosis based on histology or a combination of clinical, radiological, or biochemical and classified as Child-Pugh A or B.

Exclusion Criteria:

1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.
2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
3. Significant kidney disease
4. Estimated glomerular filtration rate (eGFR by CKD-Epi) \<60 ml/min/1.73 m2 or Cr \>2.0 mg/dL.
5. Uncontrolled hepatic encephalopathy requiring 2 or more medications to manage during the previous 3 months.
6. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).
7. Known positive HIV serology confirmed by HIV viral load.
8. Subjects with acute infections, including acute viral hepatitis are to be excluded. Subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/15/2024. Questions regarding updates should be directed to the study team contact.