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Study on the Safety and Tolerability of Norucholic Acid Tablets for Patients with Primary Sclerosing Cholangitis (PSC)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The study will use a treatment called norucholic acid, which is provided in the form of film-coated tablets. Norucholic acid is a synthetic version of a naturally occurring substance in the body known as bile acid.

The purpose of this study is to evaluate the safety and tolerability of norucholic acid in patients with PSC. Participants in the study will take norucholic acid tablets orally. The study will monitor participants over a period to observe any side effects or reactions to the treatment. The study will also look at changes in liver health and other safety measures, such as blood pressure and body weight.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that occur during the treatment. The study aims to ensure that norucholic acid is safe for use in treating PSC and to understand how it affects the liver and overall health of the participants. The study is open-label, meaning both the researchers and participants know what treatment is being administered.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of primary sclerosing cholangitis (PSC) and ensuring previous participation in the NUC 5/PSC trial.

    Eligibility criteria include being 18 years or older and having signed informed consent. Women of childbearing potential must use effective birth control during the study and for four weeks after the last dose.

  2. Step 2

    Medication administration

    The study involves taking norucholic acid tablets, known as NUT01. These are film-coated tablets taken orally.

    The dosage and frequency of administration are determined by the study protocol and are monitored throughout the trial.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to evaluate the safety and tolerability of the treatment. This includes checking for any treatment-emergent adverse events (TEAEs), serious TEAEs, severe TEAEs, adverse drug reactions (ADRs), and unexpected TEAEs.

    Secondary assessments involve monitoring changes in vital signs, body weight, hematology, serum chemistry, urinalysis, liver stiffness, and s-ALP levels from baseline to the end of treatment.

  4. Step 4

    Completion of study

    The study is estimated to end on September 30, 2027. Participants will continue to be monitored until the end of the study period.

    Upon completion, a final assessment is conducted to evaluate the overall safety and efficacy of the treatment.

Who can join the trial?

12 criteria

  • The patient must provide a signed informed consent, which means they agree to participate in the study after being informed about it.
  • The patient must be a male or female who is **18 years or older**.
  • The patient must have been previously diagnosed with **Primary Sclerosing Cholangitis (PSC)**, a liver disease.
  • The patient must have participated in a previous trial called **NUC 5/PSC** and either:
    • Completed the **DBE phase** with Visit 22, or
    • Left the DBE phase early before this new trial started, or
    • Left the DBE phase early after this new trial started, but only if it was due to the treatment not working well enough.
    • Women who can have children must use a **highly effective birth control method** with a very low chance of failure (less than 1% per year) during the study and for four weeks after the last dose. This includes methods like:
      • Hormonal birth control that stops ovulation (oral, vaginal, or skin patch)
      • Progestogen-only hormonal birth control (oral, injection, or implant)
      • Intrauterine device (IUD) or hormone-releasing system (IUS)
      • Surgical methods like **bilateral tubal occlusion** or having a partner who has had a **vasectomy**
      • Choosing not to have sex, if this is the usual lifestyle choice
      • Women who cannot have children can participate if they are surgically sterile or have not had a menstrual period for at least two years, which is known as being **post-menopausal**.

Who cannot join the trial?

9 criteria

  • Patients who have a different liver condition other than Primary Sclerosing Cholangitis (PSC) cannot participate. PSC is a disease that affects the bile ducts in the liver.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to take the study medication, which is a film-coated tablet, cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who are participating in another clinical trial at the same time cannot join this study.
  • Patients who have a history of allergic reactions to similar medications cannot participate.
  • Patients who have a history of substance abuse or alcohol abuse cannot participate.
  • Patients who have a serious mental health condition that might interfere with their ability to participate cannot join the study.
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Investigated drugs

Norucholic Acid is being studied for its safety and how well it is tolerated in patients with Primary Sclerosing Cholangitis (PSC). This medication is provided in the form of film-coated tablets and is intended to help manage the symptoms of PSC, a disease that affects the bile ducts in the liver.

What is already known about the treatment

Norucholic Acid – Norucholic acid is administered in the form of film-coated tablets, taken orally. It is currently being studied in clinical trials for its safety and tolerability in treating Primary Sclerosing Cholangitis (PSC), a chronic liver disease. The main therapeutic indication for norucholic acid is PSC, where it aims to improve liver function and reduce inflammation. At the molecular level, norucholic acid works by modifying bile acid composition, which may help in reducing liver damage. It is classified pharmacologically as a bile acid derivative.

Investigated diseases

Primary Sclerosing Cholangitis – This is a chronic liver disease characterized by inflammation and scarring of the bile ducts inside and outside the liver. Over time, the scarring can cause the bile ducts to become blocked, leading to a buildup of bile in the liver. This can result in liver damage and eventually lead to liver failure. The disease progresses slowly, and symptoms may not appear until significant liver damage has occurred. Common symptoms include fatigue, itching, and jaundice, which is a yellowing of the skin and eyes. The exact cause of Primary Sclerosing Cholangitis is unknown, but it is often associated with inflammatory bowel diseases like ulcerative colitis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514292-18-00Protocol codeNUT-022/PSCEstimated enrolment104 patientsSponsorDr. Falk Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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