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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Intestinal Failure Associated Liver Disease

In brief

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.

Key facts

Study ID

NCT05919680

Run by

NorthSea Therapeutics B.V.

People needed

36

Starts

2024-01-15

Expected to finish

2025-06-30

Last updated by the study team

2025-01-07

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Washington — Seattle, Washington, United States (enrolling)
• University of California San Francisco Medical Center — San Francisco, California, United States (enrolling)
• Mayo Clinic Scottsdale Campus — Scottsdale, Arizona, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• The University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Mayo Clinic Rochester Campus — Rochester, Minnesota, United States (enrolling)
• Mount Sinai Medical Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• The Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Vanderbilt University School of Medicine — Nashville, Tennessee, United States (enrolling)
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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