Upon joining the study, participants are randomly assigned to one of two groups: one receiving the elafibranor 80 mg tablet and the other receiving a placebo tablet. This process is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication.

Participants undergo a comprehensive initial assessment, which includes a complete physical examination, laboratory tests, and an electrocardiogram (ECG) to establish baseline health metrics.

Participants take the assigned tablet orally once daily. The dosage for those receiving elafibranor is 80 mg per day.

The treatment period lasts up to 3.5 years, with regular monitoring throughout this time.

Participants attend follow-up visits every six months. During these visits, assessments are conducted to monitor any changes in health status, including physical examinations, laboratory tests, and ECGs.

Specific health parameters such as liver function, lipid levels, and symptoms related to primary biliary cholangitis (PBC) are evaluated.

Throughout the study, any adverse events or side effects experienced by participants are recorded and assessed. This includes treatment-emergent adverse events, serious adverse events, and any events of special interest.

Participants are encouraged to report any new symptoms or changes in health to the study team during their visits.

At the end of the treatment period, participants undergo a final evaluation. This includes a comprehensive assessment similar to the initial one, focusing on any changes in health status and the overall effectiveness of the treatment.

The study aims to determine the time to occurrence of clinical outcome events and assess the long-term safety and efficacy of elafibranor in treating PBC.