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RecruitingPhase 2

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

NorthSea Therapeutics B.V. · NCT05919680

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
36
US sites recruiting
12
Study start
January 15, 2024
Record last updated
January 7, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN).

The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 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.

Being studied: NST-6179 Part A; NST-6179 Part B; Matched Placebo

Conditions: Intestinal Failure Associated Liver Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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
  • liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal [ULN]) for ≥6 months and/or
  • total bilirubin > ULN for ≥6 months.
  • Laboratory parameters consistent with stable liver disease without cirrhosis as defined by:
  • ALT and AST \<5 × ULN;
  • Total bilirubin ≤2.5 mg/dL in the absence of Gilbert's Syndrome.
  • Serum albumin ≥2.5 g/dL;
  • International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;
  • 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.

Recruiting US locations

  • Mayo Clinic Scottsdale Campus

    Scottsdale, AZ 85259

    Site contact: John DiBaise, MD

  • University of California San Francisco Medical Center

    San Francisco, CA 94143

    Site contact: Kendall Beck, MD

  • Emory University School of Medicine

    Atlanta, GA 30322

    Site contact: Thomas Ziegler, MD

  • The University of Chicago Medical Center

    Chicago, IL 60637

    Site contact: Carol Semrad, MD

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Mark Puder, MD

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Syed-Mohammed Jafri, MD

  • Mayo Clinic Rochester Campus

    Rochester, MN 55905

    Site contact: Manpreet Mundi, MD

  • Mount Sinai Medical Center

    New York, NY 10029

    Site contact: Kishore Iyer, MD

  • Duke University Medical Center

    Durham, NC 27710

    Site contact: Maria Segovia, MD

  • The Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Don Kirby, MD

  • Vanderbilt University School of Medicine

    Nashville, TN 37232

    Site contact: Dawn Adams

  • University of Washington

    Seattle, WA 98195

    Site contact: Lei Yu, MD

Study contacts (from the official record)

  • Michelle Yokley · +31 (0) 35 760 65 05 · michelle.yokley@northseatherapeutics.com
A Study of NST-6179 in Subjects With Intestinal Failure-Associated… (NCT05919680) | Bored Studies