A Study of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD).

Open to people ages 18 years and up

• 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.

• 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.