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

ClinicalTrials.gov ID: NCT05919680

Public ClinicalTrials.gov record NCT05919680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 3:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05919680
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: NorthSea Therapeutics B.V.; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Intestinal Failure Associated Liver Disease

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 16 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 14, 2024
Primary completion: Jun 29, 2025
Completion: Jun 29, 2025
Last update posted: Jan 6, 2025

2024 – 2025

United States locations

U.S. sites: 13
U.S. states: 13
U.S. cities: 13

Facility	City	State	ZIP	Site status
Mayo Clinic Scottsdale Campus	Scottsdale	Arizona	85259	Recruiting
University of California San Francisco Medical Center	San Francisco	California	94143	Recruiting
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia	20007	Not yet recruiting
Emory University School of Medicine	Atlanta	Georgia	30322	Recruiting
The University of Chicago Medical Center	Chicago	Illinois	60637	Recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Recruiting
Mayo Clinic Rochester Campus	Rochester	Minnesota	55905	Recruiting
Mount Sinai Medical Center	New York	New York	10029	Recruiting
Duke University Medical Center	Durham	North Carolina	27710	Recruiting
The Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
Vanderbilt University School of Medicine	Nashville	Tennessee	37232	Recruiting
University of Washington	Seattle	Washington	98195	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05919680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 6, 2025 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05919680 live on ClinicalTrials.gov.

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