Primary Biliary CirrhosisPhase 3NCT03301506
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
A Phase 3 study testing Seladelpar 5 mg Capsule and Seladelpar 10 mg Capsule in people with Primary Biliary Cirrhosis, run by Gilead Sciences at 109 sites in 25 countries.
Trial summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- Seladelpar 5 mg Capsule and Seladelpar 10 mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 109 sitesin 25 countries
- Study dates
- 12 Dec 2017to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Must have given written informed consent (signed and dated)
- Participated in a PBC study with seladelpar
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals 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
- Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption.
- Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
- A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
- AST or ALT above 3 × the upper limit of normal (ULN)
- Total bilirubin above 2 × ULN
- MELD score ≥ 12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
Show all 28Show fewer
- Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
- eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
- Auto-immune hepatitis
- Primary sclerosing cholangitis
- Known history of alpha-1-antitrypsin deficiency
- Known history of chronic viral hepatitis
- For females, pregnancy or breast-feeding
- Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
- Current use of fibrates or use of fibrates within 3 months prior to Screening
- Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
- Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
- History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
- Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
- 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
- Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
- Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
- Positive for:
- Hepatitis B, defined as the presence of hepatitis B surface antigen
- Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
- Human immunodeficiency virus (HIV) antibody
- Active COVID-19 infection during screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
109 sites in 25 countries.
109 sites in 25 countries
United States40 sites
Digestive Healthcare of Georgia PC
Atlanta, Georgia, 30309
University of Colorado - Denver - PPDS
Aurora, Colorado, 80045
Mercy Medical Center (Baltimore)
Baltimore, Maryland, 21202
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center - 330 Brookline Ave
Boston, Massachusetts, 02215
Galen Medical Group
Chattanooga, Tennessee, 37404
University of Chicago Hospitals
Chicago, Illinois, 60637
Gastro One-8110 Walnut Run Rd
Cordova, Tennessee, 38018
University of Texas Southwestern Medical Center
Dallas, Texas, 39090
Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Duke University Medical Center
Durham, North Carolina, 27710
Covenant Research Fort Myers
Fort Myers, Florida, 33606
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, 39157
Florida Digestive Health Specialist
Lakewood Rch, Florida, 34211
Arkansas Diagnostic Center
Little Rock, Arkansas, 72205
University of Miami Miller School of Medicine
Miami, Florida, 33136
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, 55413
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Yale University School of Medicine
New Haven, Connecticut, 06510
East Jefferson General Hospital
New Orleans, Louisiana, 70112
NYU Langone Medical Center
New York, New York, 10021
Weill Cornell Medical College
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602
Henry Ford Health System
Novi, Michigan, 48377
Stanford University School of Medicine
Palo Alto, California, 94305
California Liver Research Institute
Pasadena, California, 91105
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
University of Rochester Medical Center - PPDS
Rochester, New York, 14642
University of California Davis Medical Center
Sacramento, California, 95817
The Texas Liver Institute - 607 Camden St
San Antonio, Texas, 78215 1619
Pinnacle Clinical Research, PLLC
San Antonio, Texas, 78229
California Pacific Medical Center
San Francisco, California, 94115
Covenant Research, LLC
Sarasota, Florida, 33912
Liver Institute Northwest, PLLC
Seattle, Washington, 98195
Saint Louis University
St Louis, Missouri, 63104
United Kingdom8 sites
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
Hull Royal Infirmary
Hull, HU3 2JZ
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London, E1 1BB
King's College Hospital
London, SE5 9RS
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE4 6BE
Queen's Medical Centre
Nottingham, NG7 2UH
Derriford Hospital
Plymouth, PL6 8DH
Queen Alexandra Hospital
Portsmouth, PO6 3LY
South Korea7 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 14584
Inje University Busan Paik Hospital
Busan, 47392
Pusan National University Hospital
Busan, 49241
Kyungpook National University Hospital
Daegu, 41944
Seoul National University Bundang Hospital
Seongnam, 13620
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Songpa-Gu, 05505
Spain7 sites
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 8036
Hospital Universitario La Paz - PPDS
Horcajo de la Sierra, 28755
Hospital Universitario 12 de Octubre
Madrid, 28026
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Marques de Valdecilla
Santander, 39008
Germany6 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen, 91054
ifi-Institute for Interdisciplinary Medicine
Hamburg, 20099
Gastroenterologische Gemeinschaftspraxis Herne
Herne, 44623
Gastroenterologisch Hepatologisches Zentrum Kiel - Preetzer Chaussee 134
Kiel, 24146
Universitätsklinikum Tübingen
Tübingen, 72076
Turkey (Türkiye)5 sites
Gazi University Faculty of Medicine
Ankara, 6590
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, 35100
Ankara Bilkent City Hospital
Çankaya, 06800
Marmara University Pendik Training and Research Hospital
Maltepe, 34840
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Topkapı, 34093
Argentina4 sites
CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278
Balvanera, C1056ABJ
Hospital Italiano de Buenos Aires
Buenos Aires, 1181
DIM Clínica Privada
El Palomar, 1684
Hospital Italiano de La Plata
La Plata, B1902AWL
Israel4 sites
Carmel Medical Center
Haifa, 34462
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, 91120
The Chaim Sheba Medical Center - PPDS
Tel Aviv, 5262100
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, 6423906
Australia3 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Parkville, Victoria, 3050
Italy3 sites
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, 41126
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Palermo-Piazza Delle Cliniche 2
Palermo, 90127
Fondazione IRCCS San Gerardo dei Tintori
Rozzano, 20089
Canada2 sites
University of Calgary Medicine
Calgary, T2N 4Z6
Toronto General Hospital
Toronto, M5G 2C4
France2 sites
Hospices Civils de Lyon - Hôpital de La Croix Rousse
Lyon, 69004
AP-HP - Hôpital Saint Antoine
Paris, 75012
Hungary2 sites
Semmelweis Egyetem
Budapest, 1082
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Mexico2 sites
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
Metepec, 52120
Consultorio Medico - Distrito Federal
Roma Norte, 06700
New Zealand2 sites
Christchurch Hospital
Christchurch, 4710
Dunedin Hospital
Dunedin, 9012
Poland2 sites
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
Katowice, 40-752
ID Clinic Arkadiusz Pisula
Mysłowice, 41-400
Russia1 site
SPbGU Medical and diagnostic center of the clinic of high medical technology n.a. N.I. Pirogov
Saint Petersburg, 197110
About this study
Official title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Read the detailed description
Primary:
To evaluate the long-term safety and tolerability of seladelpar
Secondary:
- To evaluate the long-term efficacy of seladelpar
- To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Keywords
- PBC, Primary Biliary Cholangitis (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 5 mg CapsuleDrug
Also called MBX-8025, Livdelzi®
Participants will be assigned to a treatment group if tolerability issues noted in the previous study.
Seladelpar 10 mg CapsuleDrug
Also called MBX-8025, Livdelzi®
Participants will be assigned to a treatment group unless there are tolerability issues.
| Study group | Role | What they receive |
|---|---|---|
| Seladelpar 5 mg Capsules | Experimental | Not described Receives: Drug: Seladelpar 5 mg Capsule |
| Seladelpar 10 mg Capsule | Experimental | Not described Receives: Drug: Seladelpar 10 mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
Measured: Through study completion, up to 60 Months
Secondary outcomes (17)
Death
Occurrence of overall death
Measured: 60 Months
Liver transplantation
Occurrence of overall liver transplantation
Measured: 60 Months
Change in MELD
MELD score ≥ 15 for at least 2 consecutive visits
Measured: 60 Months
Ascites
Occurrence of overall ascites requiring treatment
Measured: 60 Months
Hospitalization for variceal bleeding
Hospitalization for new onset, or recurrence, of variceal bleeding
Measured: 60 Months
Hospitalization for hepatic encephalopathy
Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
Measured: 60 Months
Hospitalization for spontaneous bacterial peritonitis
Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
Measured: 60 Months
Response on composite endpoint
Alkaline phosphate (ALP)
Measured: 60 Months
Response on composite endpoint
Total bilirubin
Measured: 60 Months
Normalization of ALP
Proportion of subjects with normalization of ALP
Measured: 60 Months
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Serum Alkaline Phosphatase (ALP)
Measured: Through study completion, up to 60 Months
Laboratory Value: Aspartate Aminotransferase (AST)
Aspartate Aminotransferase (AST)
Measured: Through study completion, up to 60 Months
Laboratory Value: Alanine Aminotransferase (ALT)
Alanine Aminotransferase (ALT)
Measured: Through study completion, up to 60 Months
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Gamma-glutamyl Transferase (GGT)
Measured: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Total Bilirubin
Bilirubin - Total Bilirubin
Measured: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Conjugated Bilirubin
Bilirubin - Conjugated Bilirubin
Measured: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Bilirubin - Unconjugated Bilirubin
Measured: Through study completion, up to 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start12 Dec 2017
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Biliary CirrhosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
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
- NCT03301506
- Sponsor's protocol ID
- CB8025-31731-RE
- Other IDs
- 2020-005198-29, 2024-511753-22-00
- Status last verified
- May 2026
- First submitted
- 26 Sep 2017
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowlus CL, Hirschfield GM, Villamil AM, Kowdley KV, Elbeshbeshy H, Corpechot C, Kremer AE, Trivedi PJ, Kallis Y, Jeong SH, Kwon KM, de Ledinghen V, Qi X, Crittenden DB, Levy C; ASSURE Investigators. Seladelpar improves liver stiffness in PBC: ASSURE interim analysis. JHEP Rep. 2026 Oct 6;8(12):102057. doi: 10.1016/j.jhepr.2026.102057. Online ahead of print.
PubMed 42838175Levy C, Trivedi PJ, Kowdley KV, Gordon SC, Bowlus CL, Londono MC, Hirschfield GM, Gulamhusein A, Lawitz EJ, Vierling JM, Mayo MJ, Jacobson IM, Kremer AE, Corpechot C, Jones D, Buggisch P, Zhuo S, Proehl S, Heusner C, McWherter CA, Crittenden DB; ASSURE Investigators. Long-Term Efficacy and Safety of Selective PPARdelta Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results. Am J Gastroenterol. 2025 Jun 24;121(5):1140-53. doi: 10.14309/ajg.0000000000003603. Online ahead of print.
PubMed 40553148Mayo MJ, Vierling JM, Bowlus CL, Levy C, Hirschfield GM, Neff GW, Galambos MR, Gordon SC, Borg BB, Harrison SA, Thuluvath PJ, Goel A, Shiffman ML, Swain MG, Jones DEJ, Trivedi P, Kremer AE, Aspinall RJ, Sheridan DA, Dorffel Y, Yang K, Choi YJ, McWherter CA. Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. Aliment Pharmacol Ther. 2024 Jan;59(2):186-200. doi: 10.1111/apt.17755. Epub 2023 Oct 30.
PubMed 37904314
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
- ClinicalTrials.gov ID
- NCT03301506
- Acronym / sponsor ID
- CB8025-31731-RE
- Conditions
- Primary Biliary Cirrhosis
- Keywords
- PBC, Primary Biliary Cholangitis (PBC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Oct 2017 (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.
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Detailed description
Primary:
To evaluate the long-term safety and tolerability of seladelpar
Secondary:
- To evaluate the long-term efficacy of seladelpar
- To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seladelpar 5 mg Capsules | Experimental | Drug: Seladelpar 5 mg Capsule |
| Seladelpar 10 mg Capsule | Experimental | Drug: Seladelpar 10 mg Capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have given written informed consent (signed and dated)
- Participated in a PBC study with seladelpar
- Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals 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 (28 listed)
- Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption.
- Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
- A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
- AST or ALT above 3 × the upper limit of normal (ULN)
- Total bilirubin above 2 × ULN
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 5 mg CapsuleAlso: MBX-8025, Livdelzi®Participants will be assigned to a treatment group if tolerability issues noted in the previous study. | Drug | Seladelpar 5 mg Capsules |
| Seladelpar 10 mg CapsuleAlso: MBX-8025, Livdelzi®Participants will be assigned to a treatment group unless there are tolerability issues. | Drug | Seladelpar 10 mg Capsule |
Primary outcome
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
Time frame: Through study completion, up to 60 Months
17 secondary outcomes
Death
Time frame: 60 Months
Liver transplantation
Time frame: 60 Months
Change in MELD
Time frame: 60 Months
Ascites
Time frame: 60 Months
Hospitalization for variceal bleeding
Time frame: 60 Months
Hospitalization for hepatic encephalopathy
Time frame: 60 Months
Hospitalization for spontaneous bacterial peritonitis
Time frame: 60 Months
Response on composite endpoint
Time frame: 60 Months
Response on composite endpoint
Time frame: 60 Months
Normalization of ALP
Time frame: 60 Months
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Aspartate Aminotransferase (AST)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Alanine Aminotransferase (ALT)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Total Bilirubin
Time frame: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Conjugated Bilirubin
Time frame: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Time frame: Through study completion, up to 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 42838175Bowlus CL, Hirschfield GM, Villamil AM, Kowdley KV, Elbeshbeshy H, Corpechot C, Kremer AE, Trivedi PJ, Kallis Y, Jeong SH, Kwon KM, de Ledinghen V, Qi X, Crittenden DB, Levy C; ASSURE Investigators. Seladelpar improves liver stiffness in PBC: ASSURE interim analysis. JHEP Rep. 2026 Oct 6;8(12):102057. doi: 10.1016/j.jhepr.2026.102057. Online ahead of print.
- Derived from this study: PubMed 40553148Levy C, Trivedi PJ, Kowdley KV, Gordon SC, Bowlus CL, Londono MC, Hirschfield GM, Gulamhusein A, Lawitz EJ, Vierling JM, Mayo MJ, Jacobson IM, Kremer AE, Corpechot C, Jones D, Buggisch P, Zhuo S, Proehl S, Heusner C, McWherter CA, Crittenden DB; ASSURE Investigators. Long-Term Efficacy and Safety of Selective PPARdelta Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results. Am J Gastroenterol. 2025 Jun 24;121(5):1140-53. doi: 10.14309/ajg.0000000000003603. Online ahead of print.
- Derived from this study: PubMed 37904314Mayo MJ, Vierling JM, Bowlus CL, Levy C, Hirschfield GM, Neff GW, Galambos MR, Gordon SC, Borg BB, Harrison SA, Thuluvath PJ, Goel A, Shiffman ML, Swain MG, Jones DEJ, Trivedi P, Kremer AE, Aspinall RJ, Sheridan DA, Dorffel Y, Yang K, Choi YJ, McWherter CA. Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis. Aliment Pharmacol Ther. 2024 Jan;59(2):186-200. doi: 10.1111/apt.17755. Epub 2023 Oct 30.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
109 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seladelpar 5 mg Capsule and Seladelpar 10 mg Capsule in people with Primary Biliary Cirrhosis, run by Gilead Sciences at 109 sites in 25 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 3 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, United Kingdom, South Korea, Spain, Germany and 20 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results (time frame: Through study completion, up to 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03301506, which also lists 3 linked publications.
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 May 2026.