Evaluating NST-6179 for liver disease related to intestinal failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of NST-6179 in adults with intestinal failure-associated liver disease (IFALD) who are on parenteral nutrition. The study will enroll up to 36 participants, who will be randomly assigned to receive either NST-6179 or a placebo in two parts, with varying dosages and durations. Part A involves a 4-week treatment period with a daily dose of 800 mg, while Part B extends to 12 weeks with a planned dose of 1200 mg. The trial aims to gather data on the drug's effects and safety profile in this specific patient population.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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.

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.

Where it's running

• Mayo Clinic Scottsdale Campus
  Scottsdale, Arizona, United States Recruiting
• University of California San Francisco Medical Center
  San Francisco, California, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• The University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: Michelle Yokley
• Email: michelle.yokley@northseatherapeutics.com
• Phone: +31 (0) 35 760 65 05

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Apraglutide vs placebo in adults with short bowel syndrome and intestinal failure

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.