New study tests how liver problems affect PBC drug processing

NCT ID NCT04950764

Knowledge-focused Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study looked at how the drug seladelpar (Livdelzi) is processed in 24 people with primary biliary cholangitis (PBC) who also have liver impairment. Researchers measured drug levels in the blood and urine to see how the liver condition affects the drug. The goal was to gather information for future dosing recommendations, not to treat the disease directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Seladelpar (Livdelzi)
What this could lead to: If successful, this study could help doctors determine the right dose of seladelpar for people with PBC who also have liver problems, making treatment safer and more effective.
What could go wrong: This is a small, early-phase study (Phase 1) focused on drug levels, not on treating the disease. It may not lead to changes in how the drug is used, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Nov 2021

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females between 18 and 80 years of age (inclusive) who are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF) 2. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use the contraceptive methods throughout the study and for 30 days after study drug administration. 3. For at least 90 days after study drug administration, non-vasectomized males must not donate sperm, be willing to use contraception with childbearing potential partners and any male participant with a pregnant partner must use a condom. 4. Willing to abstain from consuming grapefruit, pomelo, star fruit, or Seville orange containing products from 7 days prior to dose of study medication through day of discharge. 5. Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C 6. Screening laboratory parameters: * Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 10 × upper Limit of normal (ULN) * Total bilirubin ≤ 5 × ULN 7. Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1 8. At screening confirmed diagnosis of PBC 9. Model for end-stage liver disease (MELD)-Na scores of 6 to 24 Exclusion Criteria: 1. Clinically significant or history of acute or chronic liver disease of an etiology other than PBC 2. Patients with a diagnosis of overlapping PBC and autoimmune hepatitis 3. History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms. 4. Presumptive or diagnosed infection that requires systemic therapy within 12 weeks of Screening and through Day 1 5. Female participants who are pregnant or nursing 6. Screening electrocardiogram (ECG) that demonstrates a QT interval ≥ 500 msec, or any other significant ECG finding with clinically significant abnormalities as determined by the Investigator 7. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus - ribonucleic acid (HCV RNA), or anti human immunodeficiency virus (HIV) antibody 8. Any non-hepatic acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in the study or compromise the integrity of the data 9. Has experienced an illness that is considered by the Investigator to be clinically significant within 2 weeks before administration of investigational product 10. Clinically relevant drug or alcohol abuse within 6 months of Screening. A positive drug screen will exclude participants unless it can be explained by a prescribed medication 11. Use of obeticholic acid (OCA), any drug of the same class, or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) within 30 days of Baseline 12. Use of an experimental or unapproved treatment for PBC within 30 days of Baseline 13. Clinically evident complication(s) of cirrhosis and portal hypertension that required either emergency room visit, hospital admission or both during the 12 week period prior to investigational product administration Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver liver disorder primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Compensated cirrhosis Hepatic impairment Primary biliary cholangitis

Contacts and locations

Locations

American Research Corporation

San Antonio, Texas, 78215, United States
Arizona Liver Health

Chandler, Arizona, 85224, United States
Henry Ford Health System

Novi, Michigan, 48377, United States
Hospital General Universitario Gregorio Maran

Madrid, 28007, Spain
Inje University Busan Paik Hospital

Busan, South Korea
Kings College Hospital

London, SE5 9RS, United Kingdom
Kyungpook National University Hospital

Daegu, 41944, South Korea
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mercy Medical Center

Baltimore, Maryland, 21202, United States
NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham

Birmingham, B15 2GW, United Kingdom
Pinnacle Clinical Research- SA

San Antonio, Texas, 78229, United States
Pusan National University Hospital

Busan, 49241, South Korea
Seoul National University Hospital

Seoul, 3080, South Korea
Severance Hospital Yonsei University Health System

Seoul, 3722, South Korea
Southern Therapy and Advanced Research LLC

Jackson, Mississippi, 39216, United States
The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States
The Royal Free London NHS Foundation Trust

London, NW2 2QG, United Kingdom
University of California Davis

Sacramento, California, 95817, United States
University of Colorado Anschutz

Aurora, Colorado, 80045, United States
Weill Medical College of Cornell University

New York, New York, 10021, United States

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