Ensayos clínicos

Key Inclusion Criteria:

- Adult persons aged 18 years or older at the time of informed consent.

- Minimum of 6 months on Parenteral supplementation.

- Established clinical diagnosis of IFALD based on a persistent elevation of

1. liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal [ULN]) for ≥6
months and/or

2. total bilirubin > ULN for ≥6 months.

- Laboratory parameters consistent with stable liver disease without cirrhosis as
defined by:

1. ALT and AST <5 × ULN;

2. Total bilirubin ≤2.0 mg/dL in the absence of Gilbert's Syndrome.

3. Serum albumin ≥3 g/dL;

4. International normalized ratio (INR) ≤1.3 in the absence of anticoagulant
therapy;

5. Platelet count ≥120,000/mm3.

Key Exclusion Criteria:

- Clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or
chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver
disease.

- Clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by
historical liver histology, ultrasound-based and/or signs and symptoms of hepatic
decompensation (including, but not limited to, jaundice, ascites, variceal hemorrhage,
and/or hepatic encephalopathy).

- Presence of hepatic impairment, end-stage liver disease, and/or a model for end-stage
liver disease (MELD) score >12.

- Transient elastography read >20.0 kPA within 3 months prior to or during the Screening
Period.

- Estimated glomerular filtration rate <45 mL/min based on the 2021 CKD-EPI creatinine
equation.

- Poor nutritional status defined as body mass index (BMI) <17 kg/m2.

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

Eligibility last updated 4/8/2024. Questions regarding updates should be directed to the study team contact.