RecruitingPhase 2

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

United States36 participantsStarted 2024-01-15

Plain-language summary

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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the safety and tolerability of NST-6179

Timeframe: Up to 14 Weeks

To assess the pharmacokinetics of NST-6179

Timeframe: Day 1 and Day 14

To assess the pharmacodynamic effects of NST-6179 on hepatic steatosis

Timeframe: 12 weeks

To assess the pharmacodynamic effects of NST-6179 on hepatic inflammation

Timeframe: 12 weeks

To assess the pharmacodynamic effects of NST-6179 on hepatic cholestasis (bilirubin, ALP, GGT)

Timeframe: 12 weeks

To assess the pharmacodynamic effects of NST-6179 on hepatic fibrosis (ELF, Pro-C3, FIB-4)

Timeframe: 12 weeks

Trial details

NCT IDNCT05919680

SponsorNorthSea Therapeutics B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Michelle Yokley

+31 (0) 35 760 65 05 michelle.yokley@northseatherapeutics.com

View on ClinicalTrials.gov More Intestinal Failure Associated Liver Disease trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

What they're measuring

To assess the safety and tolerability of NST-6179

Timeframe: Up to 14 Weeks

To assess the pharmacokinetics of NST-6179

Timeframe: Day 1 and Day 14

To assess the pharmacodynamic effects of NST-6179 on hepatic steatosis

Timeframe: 12 weeks

To assess the pharmacodynamic effects of NST-6179 on hepatic inflammation

Timeframe: 12 weeks

To assess the pharmacodynamic effects of NST-6179 on hepatic cholestasis (bilirubin, ALP, GGT)

Timeframe: 12 weeks

To assess the pharmacodynamic effects of NST-6179 on hepatic fibrosis (ELF, Pro-C3, FIB-4)

Timeframe: 12 weeks