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Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis

Verified siteInvestigationalNo placebo
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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 the disease known as Primary Biliary Cholangitis (PBC). PBC is a chronic liver disease that slowly destroys the bile ducts in the liver. The treatment being tested in this study is a medication called Seladelpar, which is taken in capsule form. The study will use two different dosages of Seladelpar: 50 mg and 100 mg capsules. The purpose of the study is to evaluate the long-term safety and tolerability of Seladelpar in individuals with PBC.

Participants in the study will take Seladelpar orally, which means they will swallow the capsules. The study will monitor participants over a period to observe any side effects or changes in their health. This will help researchers understand how well people tolerate the medication over time. The study will also collect information on various health markers, such as liver function tests, to see how the medication affects the body.

Throughout the study, participants will have regular check-ups to ensure their safety and to gather necessary data. The study aims to provide valuable information on the use of Seladelpar for treating PBC, contributing to the understanding of its long-term effects and potential benefits for individuals with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing informed consent, which involves signing and dating a document that confirms understanding and agreement to participate in the study.

    Eligibility requires previous participation in a study involving seladelpar for primary biliary cholangitis (PBC) or completion of a future study that allows continuation into this trial.

  2. Step 2

    Medication administration

    The medication seladelpar is administered orally in the form of a capsule.

    The dosage and frequency of administration are determined by the study protocol and are designed to evaluate the long-term safety and tolerability of the medication.

  3. Step 3

    Safety and health monitoring

    Regular monitoring of health and safety is conducted throughout the study. This includes collecting data on any adverse effects, as well as biochemistry and hematology results.

    The study aims to identify any treatment-emergent adverse events using established criteria.

  4. Step 4

    Evaluation of clinical outcomes

    The study evaluates specific clinical outcomes related to PBC, such as overall survival, liver transplantation needs, and other liver-related health issues.

    Biochemical markers are assessed, including changes in alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), and bilirubin levels.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by February 28, 2026.

    Participants are required to continue using effective birth control methods for at least 90 days after the last dose of seladelpar.

Who can join the trial?

4 criteria

  • Must have given informed consent, which means you have signed and dated a document agreeing to participate in the study after being informed about it.
  • Must have participated in a previous study related to Primary Biliary Cholangitis (PBC) with the medication seladelpar, or be part of a current or future study that allows you to join this one.
  • If you are a female who can have children, you must use at least one barrier method of birth control, like a condom, and another effective method during the study and for at least 90 days after the last dose of the study medication.
  • If you are a male who is sexually active with a female partner who can have children, you must use a barrier method of birth control, and your partner must use another effective method during the study and for at least 90 days after the last dose of the study medication.

Who cannot join the trial?

9 criteria

  • Patients who have any other serious liver disease besides Primary Biliary Cholangitis (a condition where the bile ducts in the liver are slowly destroyed).
  • Patients who have had a liver transplant.
  • Patients with severe heart problems.
  • Patients with uncontrolled diabetes (a condition where blood sugar levels are too high).
  • Patients with a history of cancer in the last 5 years, except for some skin cancers.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy to the study medication or similar drugs.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Seladelpar is a medication being studied for its safety and tolerability in people with a liver condition called Primary Biliary Cholangitis (PBC). This condition affects the bile ducts in the liver, and seladelpar is being tested to see if it can be used safely over a long period to help manage this disease.

What is already known about the treatment

Seladelpar – Seladelpar is administered orally and is currently being studied in clinical trials for its safety and tolerability in treating Primary Biliary Cholangitis (PBC). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for Seladelpar is Primary Biliary Cholangitis, a chronic liver disease. At the molecular level, Seladelpar works by activating a specific receptor in the body that helps reduce inflammation and improve liver function. It is classified pharmacologically as a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.

Investigated diseases

Primary Biliary Cholangitis – This is a chronic disease that slowly damages the bile ducts in the liver. Over time, the bile ducts become inflamed and are gradually destroyed, leading to a buildup of bile in the liver. This accumulation can cause liver damage and scarring, known as cirrhosis. The disease often progresses slowly, and symptoms may not appear until significant liver damage has occurred. Common symptoms include fatigue, itchy skin, and dry eyes and mouth. As the disease advances, it can lead to more severe liver problems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511753-22-00Protocol codeCB8025-31731-REEstimated enrolment339 patientsSponsorGilead Sciences Inc.

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