Adult persons aged 16 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 ≤2.5 mg/dL in the absence of Gilbert's Syndrome.
3. Serum albumin ≥2.5 g/dL;
4. International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;
5. Platelet count ≥120,000/mm3.
You may not be if
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.
