Primary Biliary CholangitisPhase 2NCT07841977
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
A Phase 2 study testing Seladelpar, PTM Seladelpar and Cilofexor Dose B in people with Primary Biliary Cholangitis, run by Gilead Sciences at 4 sites in United States.
Trial summary
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants 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 Cholangitis
- What is being tested?
- Seladelpar, PTM Seladelpar and Cilofexor Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2026to Jun 2034
- Phase
- Phase 2
- 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
- Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:
- ALP above 1.0 × the ULN for at least 6 months
- Positive antimitochondrial antibody titer (> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
- Documented liver biopsy results consistent with PBC
- Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for > 6 months prior to screening), or intolerant to UDCA (last dose of UDCA > 90 days prior to screening)
- Have an ALP ≥ 1.67 × ULN at screening
- Have a negative serum pregnancy test at screening
Who cannot join
- Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
- Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
- Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
- Have previous exposure to seladelpar or cilofexor
- Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
- Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for > 2 weeks during the study
- Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
United States4 sites, 4 recruiting
- Recruiting
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327
- Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
- Recruiting
GI Associates of Northeast Tennessee
Johnson City, Tennessee, 37604
- Recruiting
Florida Research Institute
Lakewood Rch, Florida, 34211
About this study
Official title: A Phase 2 Proof-of-Concept Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Active Treatment Extension Period to Assess the Safety and Efficacy of Seladelpar and Cilofexor in Combination for Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC).
The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Seladelpar, PTM Seladelpar, Cilofexor Dose B, PTM Cilofexor Dose A, PTM Cilofexor Dose B
- 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.
SeladelparDrug
Capsule administered orally
PTM SeladelparDrug
Capsule administered orally
Cilofexor Dose BDrug
Tablet administered orally
PTM Cilofexor Dose ADrug
Tablet administered orally
PTM Cilofexor Dose BDrug
Tablet administered orally
Cilofexor Dose ADrug
Tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B | Experimental | Participants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and CILO Dose B tablets, once daily up to 24 weeks.
At completion of Week 24, participants will continue in an Active Treatment Extension (ATE) Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312. Receives: Drug: Seladelpar; Drug: Cilofexor Dose B; Drug: PTM Cilofexor Dose A |
| SEL 10 mg + CILO Dose A + PTM CILO Dose B | Experimental | Participants will receive a dose of SEL 10 mg capsule along with CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks.
At completion of Week 24, participants will continue in an ATE Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312. Receives: Drug: Seladelpar; Drug: PTM Cilofexor Dose B; Drug: Cilofexor Dose A |
| SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B | Active comparator | Participants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks.
At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312. Receives: Drug: Seladelpar; Drug: PTM Cilofexor Dose A; Drug: PTM Cilofexor Dose B |
| PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B | Placebo comparator | Participants will receive a dose of PTM SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets once daily up to 24 weeks.
At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312. Receives: Drug: PTM Seladelpar; Drug: PTM Cilofexor Dose A; Drug: PTM Cilofexor Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Measured: Baseline, Week 24
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Measured: First dose up to 30 days post last dose (up to 318 weeks)
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Measured: First dose up to 30 days post last dose (up to 318 weeks)
Secondary outcomes (3)
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Defined as the percentage of participants with ALP < 1.67 × upper limit of normal (ULN), ALP decrease of ≥ 15%, and total bilirubin ≤ 1 × ULN.
Measured: Week 24
Proportion of Participants Achieving ALP Normalization at Week 24
ALP Normalization is defined as ALP ≤ 1.0 × ULN.
Measured: Week 24
Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2026
- Primary completionDec 2028 (estimated)
- Study completionJun 2034 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 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
- NCT07841977
- Sponsor's protocol ID
- GS-US-763-7930
- Other IDs
- 2026-525722-37
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Proof-of-Concept Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Active Treatment Extension Period to Assess the Safety and Efficacy of Seladelpar and Cilofexor in Combination for Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT07841977
- Acronym / sponsor ID
- GS-US-763-7930
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 25 Sep 2026 (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.
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC).
The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B | Experimental | Drug: Seladelpar, Drug: Cilofexor Dose B, Drug: PTM Cilofexor Dose AParticipants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an Active Treatment Extension (ATE) Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312. |
| SEL 10 mg + CILO Dose A + PTM CILO Dose B | Experimental | Drug: Seladelpar, Drug: PTM Cilofexor Dose B, Drug: Cilofexor Dose AParticipants will receive a dose of SEL 10 mg capsule along with CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312. |
| SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B | Active comparator | Drug: Seladelpar, Drug: PTM Cilofexor Dose A, Drug: PTM Cilofexor Dose BParticipants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312. |
| PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B | Placebo comparator | Drug: PTM Seladelpar, Drug: PTM Cilofexor Dose A, Drug: PTM Cilofexor Dose BParticipants will receive a dose of PTM SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:
- Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for > 6 months prior to screening), or intolerant to UDCA (last dose of UDCA > 90 days prior to screening)
- Have an ALP ≥ 1.67 × ULN at screening
- Have a negative serum pregnancy test at screening
Key exclusion criteria (8 listed)
- Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
- Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
- Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
- Have previous exposure to seladelpar or cilofexor
- Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
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 |
|---|---|---|
| SeladelparCapsule administered orally | Drug | SEL 10 mg + CILO Dose A + PTM CILO Dose B, SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B, Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B |
| PTM SeladelparCapsule administered orally | Drug | PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B |
| Cilofexor Dose BTablet administered orally | Drug | Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B |
| PTM Cilofexor Dose ATablet administered orally | Drug | PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B, SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B, Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B |
| PTM Cilofexor Dose BTablet administered orally | Drug | PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B, SEL 10 mg + CILO Dose A + PTM CILO Dose B, SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B |
| Cilofexor Dose ATablet administered orally | Drug | SEL 10 mg + CILO Dose A + PTM CILO Dose B |
Primary outcome
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose up to 30 days post last dose (up to 318 weeks)
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose up to 30 days post last dose (up to 318 weeks)
3 secondary outcomes
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Time frame: Week 24
Proportion of Participants Achieving ALP Normalization at Week 24
Time frame: Week 24
Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline, Week 24
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 27 Oct 2026.
- 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.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seladelpar, PTM Seladelpar and Cilofexor Dose B in people with Primary Biliary Cholangitis, run by Gilead Sciences at 4 sites in United States.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24 (time frame: Baseline, Week 24). The study lists 3 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 27 Oct 2026.