for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in adult subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 adult subjects diagnosed with IFALD will be enrolled in the study, of which 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.

Official Title

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD)


Intestinal Failure Associated Liver Disease, Liver Diseases, Intestinal Failure, NST-6179 Part A, NST-6179 Part B


You can join if…

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.

You CAN'T join 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.


  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • Stanford Medical Center not yet accepting patients
    Palo Alto California 94304 United States
  • University of Washington accepting new patients
    Seattle Washington 98195 United States


accepting new patients
Start Date
Completion Date
NorthSea Therapeutics B.V.
Phase 2 Liver Disease Research Study
Study Type
Expecting 36 study participants
Last Updated