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NST-6179 for Liver Disease

Phase 2
Recruiting
Research Sponsored by NorthSea Therapeutics B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total bilirubin ≤2.0 mg/dL in the absence of Gilbert's Syndrome.
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 14

Summary

This trial will study the safety, effectiveness, and how the body processes a new drug for intestinal failure-associated liver disease. Up to 36 adults will be enrolled, with 18 in each part of the study taking either the drug or placebo.

Who is the study for?
Adults over 18 with Intestinal Failure-Associated Liver Disease (IFALD) who have been on parenteral nutrition for at least 6 months can join. They must have certain liver enzyme levels above normal or high bilirubin, but not too high, and meet other blood test criteria.
What is being tested?
The trial is testing NST-6179's safety and effects in two parts: Part A gives a daily oral dose of either the drug or placebo for four weeks; Part B may increase the dose for twelve weeks based on earlier results.
What are the potential side effects?
Specific side effects are not listed here, but generally, participants will be monitored for any adverse reactions to NST-6179 compared to those taking a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My total bilirubin level is 2.0 mg/dL or less, and I don't have Gilbert's Syndrome.
Select...
Please provide more details for an accurate summary.
Select...
I am 18 years old or older.
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I have been on IV nutrition for at least 6 months.
Select...
I have been diagnosed with IFALD due to ongoing high liver enzyme levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the pharmacodynamic effects of NST-6179 on hepatic cholestasis (bilirubin, ALP, GGT)
To assess the pharmacodynamic effects of NST-6179 on hepatic fibrosis (ELF, Pro-C3, FIB-4)
To assess the pharmacodynamic effects of NST-6179 on hepatic inflammation
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part B- 1200mg NST-6179Experimental Treatment1 Intervention
up to 12 subjects
Group II: Part B matched NST-6179 placeboExperimental Treatment1 Intervention
up to 6 subjects
Group III: Part A-800 mg NST-6179Experimental Treatment1 Intervention
up to 12 subjects
Group IV: Part A matched NST-6179 placeboExperimental Treatment1 Intervention
up to 6 subjects

Find a Location

Who is running the clinical trial?

NorthSea Therapeutics B.V.Lead Sponsor
6 Previous Clinical Trials
552 Total Patients Enrolled
~15 spots leftby Jun 2025
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