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Seladelpar

Clinical trials are investigating Seladelpar in people with primary biliary cholangitis, including those with compensated cirrhosis. These studies are looking at safety, tolerability, and whether treatment can improve clinical outcomes over time.

Table of Contents

Trial overview

Two authorised Phase 3 clinical trials are studying Seladelpar in people with primary biliary cholangitis (PBC).[1][2] One study also includes patients with compensated cirrhosis, which means liver scarring that is still stable.[1]

These trials are interventional, so researchers give a study treatment and then measure what happens.[1][2] The main aim is to learn about safety, long-term tolerability, and whether Seladelpar can improve clinical outcomes in these patient groups.[1][2]

Who the studies include

Both trials focus on people with PBC.[1][2] The AFFIRM study, NCT06051617, specifically includes patients with PBC and compensated cirrhosis.[1]

This target group is important because the studies are not looking at the general public; they are focused on patients who already have a defined liver condition.[1][2]

What researchers measure

In NCT06051617, the main outcome is event-free survival (EFS), which means the time from the start of treatment until the first major liver-related event happens.[1] The events include death from any cause, liver transplantation, a MELD score of 15 or higher, ascites needing treatment, or hospitalization for certain complications such as variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.[1]

The same trial also measures safety over 156 weeks.[1] In NCT03301506, the main outcome is treatment-emergent adverse events, along with biochemistry and hematology results, which are lab tests that help researchers see how the body responds to treatment.[2]

How the trials are designed

NCT06051617 is a randomized, double-blind, placebo-controlled study.[1] Randomized means participants are assigned by chance, double-blind means neither the participant nor the study team knows which treatment is given, and placebo-controlled means the study compares Seladelpar with a look-alike treatment that has no active medicine.[1]

This study compares Seladelpar 5 mg and 10 mg oral treatment with matching placebos.[1] NCT03301506 is also an interventional Phase 3 study and evaluates Seladelpar 10 mg oral treatment in people with PBC.[2]

Trial status and size

Both trials are listed as Authorised in the source data.[1][2] NCT06051617 plans to include 168 participants, while NCT03301506 plans to include 339 participants.[1][2]

The larger enrollment in NCT03301506 may help researchers collect more safety and tolerability data over time.[2] The AFFIRM study is focused on long-term clinical outcomes over 156 weeks, which is a little over three years.[1]

Key patient terms

  • Ascites means fluid builds up in the belly and may need treatment.[1]

  • Hepatic encephalopathy is a brain problem caused by severe liver disease that can affect thinking and alertness.[1]

  • Spontaneous bacterial peritonitis is an infection of the fluid in the belly.[1]

  • Biochemistry and hematology are blood tests that help researchers check liver-related chemicals and blood cells.[2]

  • Tolerability means how well people can take the study treatment without major problems.[2]

Trial ID Phase Condition studied Status Enrollment
NCT06051617 Phase 3 Primary Biliary Cholangitis; compensated cirrhosis Authorised 168
NCT03301506 Phase 3 Primary Biliary Cholangitis Authorised 339

FAQ

  • What conditions are being studied in Seladelpar trials? The trials in this data study primary biliary cholangitis, also called PBC. One trial also includes patients with compensated cirrhosis, which means liver scarring that is still stable and not yet causing major liver failure.
  • What is the main goal of these Seladelpar trials? One trial is testing whether Seladelpar can improve clinical outcomes over 156 weeks. Another trial is focused on long-term safety and tolerability, which means how well people can take the treatment over time.
  • What phase are the Seladelpar trials in? Both trials in the source data are Phase 3 studies. Phase 3 trials compare treatment effects in larger groups of people and help measure how well a treatment works and how safe it is.
  • Who may take part in these trials? The trials are for adults with primary biliary cholangitis. One study also includes people with compensated cirrhosis, so the target group is patients with PBC and, in one trial, stable liver scarring.
  • What outcomes are researchers measuring? Researchers are measuring event-free survival, or EFS, in one study. EFS means the time before a major liver-related event happens, such as death, liver transplant, worsening liver scores, ascites needing treatment, or certain hospitalizations.

Ongoing Clinical Trials on Seladelpar

  • Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis

    Recruiting

    3 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +7

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

    Not recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +6

Glossary

  • Primary biliary cholangitis (PBC): A long-term liver disease studied in these trials. It affects the small bile ducts in the liver and can lead to liver damage over time.
  • Compensated cirrhosis: Liver scarring that is still stable. The liver is damaged, but it is still working well enough to avoid major complications.
  • Phase 3: A later stage of clinical research with larger groups of participants. These studies help show whether a treatment works and how safe it is.
  • Randomized: Participants are assigned by chance to different study groups. This helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team knows who is getting the study treatment or placebo. This helps reduce bias.
  • Placebo: A treatment that looks like the study drug but has no active study medicine. It is used for comparison.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Enrollment: The number of people planned or included in a clinical trial.
  • Safety: How well a treatment is tolerated and whether it causes unwanted effects.
  • Tolerability: How well people are able to take a treatment without major problems.
  • Event-free survival (EFS): The time from the start of treatment until a major event happens, such as death, transplant, or worsening liver disease.
  • MELD score: A liver disease score used to show how serious liver disease is. A higher score means worse liver function.

References