Primary Biliary CholangitisPhase 3IDEALNCT06060665
Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
A Phase 3 study testing Seladelpar 10 mg in people with Primary Biliary Cholangitis, run by Gilead Sciences at 45 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Seladelpar 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 45 sitesin 2 countries
- Study dates
- 5 Sep 2023to 6 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet the following criteria to be eligible for study participation:
- Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history.
- 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).
- ALP > 1× ULN and < 1.67× ULN.
- 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.
Who cannot join
- Previous exposure to seladelpar (MBX-8025).
- 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.
- Advanced PBC as defined by the Rotterdam criteria.
- Laboratory parameters measured by the Central Laboratory at screening.
- Clinically important hepatic decompensation.
- Other chronic liver diseases.
Show all 19Show fewer
- Known history of human immunodeficiency virus (HIV) or positive antibody test at screening.
- 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.
- 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.
- History of drug abuse that would compromise the quality of the clinical study.
- Treatment with obeticholic acid or fibrates 6 weeks prior to screening.
- Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening.
- Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment of pruritus within 1 month prior to screening.
- Immunosuppressant therapies within 6 months prior to screening.
- 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.
- Treatment with any other investigational therapy or device within 30 days or within halflives, whichever is longer, prior to screening.
- Pregnancy or plans to become pregnant, or breastfeeding.
- 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.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States43 sites
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, 80045
American Research Corporation - San Antonio, TX
Austin, Texas, 78757
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, 21202
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
New-York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Chandler, Arizona, 85224
Northwestern Medicine Clinical Research Unit (CRU)
Chicago, Illinois, 60611
OGI - Gastro One
Cordova, Tennessee, 38018
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Liver Center of Texas
Dallas, Texas, 75234
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Soma Clinical Trials, LLC
Denison, Texas, 75020
South Denver Gastroenterology
Englewood, Colorado, 80113
Galen Hepatology
Hixson, Tennessee, 37343
Baylor College of Medicine - Baylor Clinic
Houston, Texas, 77030
Liver Associates of Texas, P.A.
Houston, Texas, 77030
Gastrointestinal Associates of Northeast Tennessee, P.C.
Johnson City, Tennessee, 37604
Kansas City Research Institute
Kansas City, Missouri, 64131
Florida Research Institute
Lakewood Rch, Florida, 34211
Gastro Health Research
Liberty Township, Ohio, 45044
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, 11030
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136
Gastro Health Research
Miami, Florida, 33176
University of Minnesota
Minneapolis, Minnesota, 55455
Tulane University Medical Center
New Orleans, Louisiana, 70112
New York University (NYU) Langone Medical Center
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10065
Henry Ford Health System
Novi, Michigan, 48377
California Liver Research Institute
Pasadena, California, 91105
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC Center for Liver Health
Pittsburgh, Pennsylvania, 15213
Bon Secours Liver Institute of Hampton Roads
Richmond, Virginia, 23226
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, New York, 14642
University of California (UC) Davis Medical Center
Sacramento, California, 95817
California Pacific Medical Center
San Francisco, California, 94115
Covenant Metabolic Specialists, LLC
Sarasota, Florida, 33912
Velocity Clinical Research - Seattle
Seattle, Washington, 98105
Stanford University
Seattle, Washington, 98195
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Covenant Metabolic Specialists, LLC
Tampa, Florida, 33606
Canada2 sites
Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM)
Montreal, H2X3J4
(G.I.R.I.) GI Research Institute Foundation
Vancouver, V6Z 2K5
About this study
Official title: 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.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Seladelpar 10 mg, Placebo
- Keywords
- Primary Biliary Cholangitis (PBC), PBC
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seladelpar 10 mgDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Seladelpar | Experimental | Participants will receive Seladelpar 10 mg one capsule daily for up to 52 weeks. Receives: Drug: Seladelpar 10 mg |
| Placebo | Experimental | Participants will receive placebo-to-match one capsule daily for up to 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Response defined as Alkaline phosphatase (ALP) ≤ 1.0× Upper Limit of Normal (ULN) AND ≥ 15% Decrease in ALP at Week 52.
Measured: 52 weeks
Type, Frequency, and Severity of Treatment-emergent Adverse Events.
Measured: 52 weeks
Secondary outcomes (6)
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN.
Measured: 52 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 4 Weeks.
Measured: 4 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 12 Weeks.
Measured: 12 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 26 Weeks.
Measured: 26 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 39 Weeks.
Measured: 39 weeks
Absolute and Percent Change From Baseline in ALP.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start5 Sep 2023
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060665
- Sponsor's protocol ID
- CB8025-32251
- Other IDs
- 2024-517409-10-00
- Acronym
- IDEAL
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06060665
- Acronym / sponsor ID
- IDEAL / CB8025-32251
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Primary Biliary Cholangitis (PBC), PBC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seladelpar | Experimental | Drug: Seladelpar 10 mgParticipants will receive Seladelpar 10 mg one capsule daily for up to 52 weeks. |
| Placebo | Experimental | Drug: PlaceboParticipants will receive placebo-to-match one capsule daily for up to 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history.
- 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).
- ALP > 1× ULN and < 1.67× ULN.
- 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 (19 listed)
- Previous exposure to seladelpar (MBX-8025).
- 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.
- Advanced PBC as defined by the Rotterdam criteria.
- Laboratory parameters measured by the Central Laboratory at screening.
- Clinically important hepatic decompensation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seladelpar 10 mgAdministered orally | Drug | Seladelpar |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
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
Type, Frequency, and Severity of Treatment-emergent Adverse Events.
Time frame: 52 weeks
6 secondary outcomes
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN.
Time frame: 52 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 4 Weeks.
Time frame: 4 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 12 Weeks.
Time frame: 12 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 26 Weeks.
Time frame: 26 weeks
Percentage of Participant Response Defined as ALP ≤ 1.0× ULN AND ≥ 15% Decrease in ALP at 39 Weeks.
Time frame: 39 weeks
Absolute and Percent Change From Baseline in ALP.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seladelpar 10 mg in people with Primary Biliary Cholangitis, run by Gilead Sciences at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.