A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)
Primary biliary cholangitis (PBC) is a long-term condition where the tiny bile tubes in the liver become inflamed and damaged. Over time, this can cause harmful scar tissue to build up. This clinical trial is testing an experimental medicine called saroglitazar magnesium. Researchers want to find out whether taking this tablet every day can slow down liver damage and prevent serious complications compared to a dummy pill (placebo). Participants will take either the study medicine or a placebo tablet. Neither you nor your doctor will know which one you are receiving. The study will monitor your liver health through blood tests, scans, and questionnaires about your symptoms and quality of life, especially fatigue. The goal is to see if this treatment helps people with PBC stay healthier for longer.
At a glance
What is this study about?
Primary biliary cholangitis, or PBC, is an autoimmune liver condition. In PBC, the body's defence system mistakenly attacks the small tubes (bile ducts) inside the liver. When these ducts are damaged, bile builds up and causes swelling and scarring. Without effective treatment, this scarring can lead to severe liver damage, known as cirrhosis, and in some cases, the need for a liver transplant.
This study is testing a medicine called saroglitazar magnesium. It is designed to help reduce liver inflammation and improve the way the liver processes fats and bile. While some treatments already exist for PBC, they do not work well for everyone. Researchers want to know if saroglitazar magnesium can provide better long-term protection for the liver and help manage everyday symptoms like severe fatigue.
During this study, researchers will compare the medicine against a placebo, which looks identical but contains no active ingredient. They will track participants over several years to see if the medicine prevents major liver problems, improves blood test results, and helps people feel better in their day-to-day lives.
Key takeaways
- The trial tests whether saroglitazar magnesium can slow down liver damage in people with PBC.
- Participants take a daily tablet containing either the active medicine or an inactive placebo.
- The study lasts over several years to monitor long-term outcomes and symptoms like fatigue.
- You will receive regular, detailed health checks from specialist liver doctors.
- Taking part is completely voluntary and you can leave the study at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with primary biliary cholangitis (PBC). Both men and women can take part.
Because this study looks at how well the medicine prevents long-term liver problems, doctors will need to review your medical history and recent blood test results. You may not be able to join if you have certain other liver diseases, severe kidney problems, or if you are currently taking medications that could interfere with the study drug.
If you are interested, the trial doctor will carry out a thorough health check to make sure the trial is safe and appropriate for your specific stage of PBC.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have a confirmed diagnosis of primary biliary cholangitis (PBC).
- I am able to attend regular hospital appointments for check-ups and blood tests.
- I am willing to take a daily tablet as instructed by the study doctor.
- I am not currently taking part in another clinical drug trial.
What does participation involve?
Taking part in this study involves taking a tablet once a day with water. Because this is a 'double-blind' trial, you will be randomly chosen to receive either the active medicine or a dummy pill (placebo), and neither you nor your study team will know which one you get.
You will need to attend regular clinic visits at a hospital. During these visits, doctors will check your general health, take blood and urine samples, and carry out routine liver checks. You will also be asked to complete simple questionnaires about your daily energy levels and quality of life. The study lasts for several years to carefully measure your long-term liver health, but you will be closely supported by the research team throughout.
Potential risks and benefits
Locations (12)
- —UnverifiedIreland
- —UnverifiedGreece
- —UnverifiedEstonia
- —UnverifiedNetherlands
- —UnverifiedBulgaria
- —UnverifiedSlovakia
- —UnverifiedPoland
- —UnverifiedLatvia
- —UnverifiedCroatia
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is a placebo?
A placebo is a tablet that looks and tastes identical to the real medicine but contains no active ingredients. It helps researchers prove whether the actual medicine is truly effective.
Will I have to pay for the study treatment?
No. The study medication, tests, and medical visits related to the trial are provided free of charge, and travel expenses are often covered.
Can I keep taking my usual PBC medicines?
In many cases, yes. The study team will review all your current prescriptions to check if they can be safely taken alongside the trial medication.
How long will I be in the trial?
This is a long-term study that follows participants over several years, with key check-ins at 12 months and 48 months, to see how the liver behaves over time.
What happens if my condition gets worse during the trial?
Your safety comes first. The medical team tracks your liver tests closely, and if your health worsens, they will review your care and may take you off the study to provide alternative treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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