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Recruiting Phase 2

Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis

NCT07841977 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2026-10-01
Last updated
2026-10-27

Condition(s) studied

Primary Biliary Cholangitis

Investigational drug(s) / intervention(s)

Seladelpar →PTM SeladelparCilofexor Dose BPTM Cilofexor Dose APTM Cilofexor Dose BCilofexor Dose A

Seladelpar: Capsule administered orally

PTM Seladelpar: Capsule administered orally

Cilofexor Dose B: Tablet administered orally

PTM Cilofexor Dose A: Tablet administered orally

PTM Cilofexor Dose B: Tablet administered orally

Cilofexor Dose A: Tablet administered orally

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24 — Baseline, Week 24
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) — First dose up to 30 days post last dose (up to 318 weeks)
  • Percentage of Participants Experiencing Serious Adverse Events (SAEs) — First dose up to 30 days post last dose (up to 318 weeks)

Trial sites (4)

FacilityCityRegionStatus
Peak Gastroenterology Associates Colorado Springs Colorado Recruiting
Florida Research Institute Lakewood Rch Florida Recruiting
Digestive Healthcare of Georgia Atlanta Georgia Recruiting
GI Associates of Northeast Tennessee Johnson City Tennessee Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07841977 on ClinicalTrials.gov ↗ ← All trials in the USA