Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) (IDEAL)

June 2, 2026 updated by: Gilead Sciences

IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 Study Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)

To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA).

The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada, H2X3J4
        • Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM)
      • Vancouver, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute Foundation
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
    • California
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Sacramento, California, United States, 95817
        • University of California (UC) Davis Medical Center
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver - School of Medicine - Anschutz Medical Campus
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • Florida
      • Lakewood Rch, Florida, United States, 34211
        • Florida Research Institute
      • Miami, Florida, United States, 33136
        • University of Miami - Schiff Center for Liver Diseases
      • Miami, Florida, United States, 33176
        • Gastro Health Research
      • Sarasota, Florida, United States, 33912
        • Covenant Metabolic Specialists, LLC
      • Tampa, Florida, United States, 33606
        • Covenant Metabolic Specialists, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine Clinical Research Unit (CRU)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center - Baltimore, Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute
    • New York
      • Brooklyn, New York, United States, 11215
        • New-York-Presbyterian Brooklyn Methodist Hospital
      • Manhasset, New York, United States, 11030
        • Northwell Health Center for Liver Disease and Transplantation
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10016
        • New York University (NYU) Langone Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center - Strong Memorial Hospital
    • Ohio
      • Liberty Township, Ohio, United States, 45044
        • Gastro Health Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Center for Liver Health
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • OGI - Gastro One
      • Hixson, Tennessee, United States, 37343
        • Galen Hepatology
      • Johnson City, Tennessee, United States, 37604
        • Gastrointestinal Associates of Northeast Tennessee, P.C.
    • Texas
      • Austin, Texas, United States, 78757
        • American Research Corporation - San Antonio, TX
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas, Texas, United States, 75234
        • Liver Center of Texas
      • Denison, Texas, United States, 75020
        • Soma Clinical Trials, LLC
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Baylor Clinic
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas, P.A.
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Bon Secours Liver Institute of Hampton Roads
    • Washington
      • Seattle, Washington, United States, 98105
        • Velocity Clinical Research - Seattle
      • Seattle, Washington, United States, 98195
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Individuals must meet the following criteria to be eligible for study participation:

  1. Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history.
  2. Ursodeoxycholic acid (UDCA) for the 12 months prior to screening (with stable dose for > 3 months prior to screening) OR intolerant to UDCA (last dose of UDCA > 3 months prior to screening).
  3. ALP > 1× ULN and < 1.67× ULN.
  4. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.

Key Exclusion Criteria:

  1. Previous exposure to seladelpar (MBX-8025).
  2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study (eg, cancer) or confound its results.
  3. Advanced PBC as defined by the Rotterdam criteria.
  4. Laboratory parameters measured by the Central Laboratory at screening.
  5. Clinically important hepatic decompensation.
  6. Other chronic liver diseases.
  7. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening.
  8. Clinically important alcohol consumption, defined as more than 2 drink units per day in women and 3 drink units per day in men, or inability to quantify alcohol intake reliably.
  9. History of malignancy diagnosed or treated, active or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening.
  10. History of drug abuse that would compromise the quality of the clinical study.
  11. Treatment with obeticholic acid or fibrates 6 weeks prior to screening.
  12. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening.
  13. Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment of pruritus within 1 month prior to screening.
  14. Immunosuppressant therapies within 6 months prior to screening.
  15. Other medications that affect liver or gastrointestinal functions, as well as the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case by-case basis.
  16. Treatment with any other investigational therapy or device within 30 days or within halflives, whichever is longer, prior to screening.
  17. Pregnancy or plans to become pregnant, or breastfeeding.
  18. Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seladelpar
Participants will receive Seladelpar 10 mg one capsule daily for up to 52 weeks.
Drug: Seladelpar 10 mg
Administered orally
Experimental: Placebo
Participants will receive placebo-to-match one capsule daily for up to 52 weeks.
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Response defined as Alkaline phosphatase (ALP) ≤ 1.0× Upper Limit of Normal (ULN) AND ≥ 15% Decrease in ALP at Week 52.
Time Frame: 52 weeks
52 weeks
Type, Frequency, and Severity of Treatment-emergent Adverse Events.
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN.
Time Frame: 52 weeks
52 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 4 Weeks.
Time Frame: 4 weeks
4 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 12 Weeks.
Time Frame: 12 weeks
12 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 26 Weeks.
Time Frame: 26 weeks
26 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 39 Weeks.
Time Frame: 39 weeks
39 weeks
Absolute and Percent Change From Baseline in ALP.
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Actual)

May 6, 2026

Study Completion (Actual)

May 6, 2026

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB8025-32251
  • 2024-517409-10-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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