NCT07841977 Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 132 participants in total. It began in 2026-10-01 with a primary completion date of 2028-12.

Brief 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). 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.

Eligibility Criteria

Key Inclusion Criteria: * Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria: 1. ALP above 1.0 × the ULN for at least 6 months 2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies 3. 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 Key Exclusion Criteria: * 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.

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