Study on the Safety and Effects of Orziloben (NST-6179) for Patients with Intestinal Failure-Associated Liver Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Intestinal Failure-Associated Liver Disease (IFALD). This condition affects the liver and is associated with intestinal failure, which can lead to complications in liver function. The study is testing a new treatment called Orziloben (NST-6179), which is given as an oral solution. The purpose of the study is to evaluate the safety and how well the body tolerates this treatment, as well as to understand how the drug behaves in the body over time.

The study is divided into two parts. In the first part, participants will receive multiple doses of Orziloben (NST-6179) over a period of four weeks. In the second part, the treatment will continue for twelve weeks. Throughout the study, participants will be monitored for any side effects and changes in their health. The study will also look at how the treatment affects various aspects of liver health, such as liver inflammation and fat buildup, as well as how it influences the metabolism of lipids, glucose, and bile acids.

Participants will be randomly assigned to receive either the Orziloben (NST-6179) treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study aims to provide valuable information on the potential benefits and safety of Orziloben (NST-6179) for individuals with Intestinal Failure-Associated Liver Disease.

1 joining the study

Upon joining the study, you will be required to sign a written informed consent form. This form confirms your understanding of the study’s purpose and procedures, and your agreement to comply with the study protocol.

2 initial assessments

Before starting the treatment, initial assessments will be conducted. These include blood and urine tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations. These assessments help establish a baseline for your health status.

3 part a treatment

In Part A of the study, you will receive multiple oral doses of Orziloben (NST-6179) for a duration of 4 weeks. The medication is administered as an oral solution. The purpose is to assess the safety and tolerability of the medication.

During this period, you will be monitored for any adverse effects and changes in your health status. Blood samples will be taken to study how the medication is processed in your body.

4 part a follow-up

After completing the 4-week treatment in Part A, follow-up assessments will be conducted. These include additional blood and urine tests, vital sign measurements, ECGs, and physical examinations to evaluate your response to the treatment.

5 part b treatment

In Part B of the study, you will continue to receive multiple oral doses of Orziloben (NST-6179) for an extended duration of 12 weeks. The focus is on further assessing the safety and tolerability, as well as the effects of the medication on various health markers.

Regular monitoring will continue, with blood samples taken to understand the medication’s impact on your body and to evaluate changes in specific health indicators.

6 part b follow-up

Upon completing the 12-week treatment in Part B, final follow-up assessments will be conducted. These assessments will include blood and urine tests, vital sign measurements, ECGs, and physical examinations to determine the overall impact of the treatment on your health.

Who Can Join the Study?

Persons aged 18 years or older at the time of giving consent.
Agree to use appropriate contraceptive methods based on biological sex and ability to have children.
Agree not to donate sperm or eggs for a certain period after the last dose of the study medication (90 days for sperm, 30 days for eggs).
Able to understand the purpose and procedures of the study and willing to sign a written consent form and follow the study rules.
Have a negative test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is the virus that causes COVID-19, from a test done between 3 days before and the first day of the study.
Have been on parenteral nutrition (PN) for at least 6 months before the first study visit. PN is a way of getting nutrition through a vein.
Have a stable PN regimen for 4 weeks before and during the screening period. A stable regimen means the amount and type of nutrition received is consistent with what is prescribed, within a 10% range.
Willing to keep the same level of physical activity, diet, and lifestyle throughout the study.
Have a confirmed diagnosis of Intestinal Failure-Associated Liver Disease (IFALD) based on certain liver tests being elevated for at least 6 months. These tests include liver enzymes like ALP, AST, ALT, GGT, or total bilirubin.

Who Cannot Join the Study?

Patients with a history of Intestinal Failure-Associated Liver Disease (IFALD) cannot participate. IFALD is a liver condition that occurs due to long-term intestinal failure.
Patients who are not within the specified age range for the study.
Patients who are not able to take oral medication.
Patients with any other significant medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with known allergies to the study medication or its ingredients.
Patients with a history of substance abuse or alcohol dependency.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	20.06.2025
Denmark	Not yet recruiting	20.06.2025
France	Not recruiting	20.06.2025

Trial locations

Orziloben (NST-6179) is a medication being studied for its potential benefits in people with a liver condition linked to intestinal failure. This condition can cause liver damage over time. The trial is looking at how safe and tolerable Orziloben is when taken by mouth over a period of weeks. Researchers are also studying how the body processes the medication and how it affects the liver and intestines. They are interested in seeing if Orziloben can help with liver inflammation, fat buildup in the liver, and other liver-related issues. The study also aims to understand how Orziloben might influence metabolism, which includes how the body handles fats, sugars, and bile acids. Additionally, the trial is examining how the medication might affect certain hormones and the overall health of the intestines.

Investigated diseases:

Gastrointestinal disorder

Intestinal Failure-Associated Liver Disease (IFALD) – This condition occurs when the liver is affected due to long-term dependence on parenteral nutrition, which is necessary when the intestines cannot absorb enough nutrients. Over time, the liver may accumulate fat, leading to hepatic steatosis, and experience inflammation, known as hepatic inflammation. Cholestasis, a condition where bile flow is reduced or blocked, can also develop, causing further liver damage. As the disease progresses, fibrosis, or scarring of the liver tissue, may occur, potentially affecting liver function. The disease can also impact lipid and glucose metabolism, as well as bile acid metabolism. Additionally, it may influence circulating incretins and contribute to intestinal function and injury.

Trial ID:

2024-520202-19-00

Protocol code:

NST-6179-02

NCT ID:

NCT05919680

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Orziloben (NST-6179) for Patients with Intestinal Failure-Associated Liver Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?