Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Gilead Sciences trials in the USA
Other trials for the same condition
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