NCT07841977RecruitingPhase 2
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 21 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Gilead Sciences
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07841977
- EudraCT number
- 2026-525722-37
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 132
- From 1 Oct 2026 to the primary completion date, 31 Dec 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have previous exposure to seladelpar or cilofexor
- 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.
Other illness
- Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
- 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.
Other
- 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.
- Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Digestive Healthcare of Georgia Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Peak Gastroenterology Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| GI Associates of Northeast Tennessee Coordinator of this site? Confirm its status | Johnson City | United States | Recruiting |
| Florida Research Institute Coordinator of this site? Confirm its status | Lakewood Rch | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.