Seladelpar and cilofexor together in adults with primary biliary cholangitis
Tests seladelpar combined with cilofexor, compared with seladelpar alone or placebo, in primary biliary cholangitis.
Plain-language title generated from the registry record
Registry title: Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
Key facts
- Where
- Atlanta, Colorado Springs, Johnson City, and Lakewood Rch, United StatesSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07841977, who can take part
Where in United States
- Digestive Healthcare of GeorgiaAtlanta, United StatesTaking people
- Peak Gastroenterology AssociatesColorado Springs, United StatesTaking people
- GI Associates of Northeast TennesseeJohnson City, United StatesTaking people
- Florida Research InstituteLakewood Rch, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT07841977
- Record updated
- 27 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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.