Not yet recruitingRare disease

Safety and Efficacy of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis: A Long‑Term Randomized Placebo‑Controlled Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Primary Biliary Cholangitis (PBC) is a rare, long‑lasting liver disease that slowly damages the tiny tubes (bile ducts) that carry bile out of the liver. The study examines the use of the oral tablet Saroglitazar Magnesium, taken once each day, compared with a matching inactive tablet.

The purpose of the study is to evaluate the safety and effectiveness of this medication in people with PBC. Participants are randomly assigned to receive either the active tablet or the inactive tablet, without knowing which they get. They take the assigned tablet every day and attend regular clinic visits for several years, during which doctors check their health and collect information.

Researchers will look at how long it takes for serious liver problems to appear, such as liver failure, the need for a liver transplant, or death, as well as changes in certain scores that indicate liver health. The MELD-Na score is a number that predicts how badly the liver is working, while the CPT score measures the severity of liver disease. Blood tests will monitor the level of ALP, an enzyme that rises when the liver is damaged, and doctors will also watch for signs of high blood pressure in the liver’s vein system called CSPH, which can lead to enlarged veins called varices. Participants will complete a questionnaire about their QoL to see how the treatment affects their daily wellbeing.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After you join the study you will be randomly assigned to receive either the study drug or a matching placebo. the assignment is done by a computer system and you will not know which product you receive because the study is double‑blind.
Step 2
Daily medication
You will take one tablet by mouth each day. the tablet contains either saroglitazar magnesium 1 mg or an identical placebo that looks the same. you will continue this once daily dosing for the entire duration of the trial, which may last several years.
Step 3
Regular clinic visits
You will attend scheduled visits at the study sites where health professionals will check your condition, record any events, and collect samples. visits are planned throughout the study and include specific assessments at month 12 and month 48.
Step 4
Laboratory assessments
Blood samples will be taken to measure liver enzymes and other markers. the level of ALP (alkaline phosphatase) will be examined to see if it reaches the normal range (≤ upper limit of normal) at month 12 and again at month 48. other tests will evaluate the MELD‑Na score, total bilirubin, and any signs of liver decompensation.
Step 5
Quality‑of‑life questionnaire
At month 12 you will complete the PBC‑40 questionnaire that asks about fatigue and other aspects of daily living. this helps the study understand how the medication may affect your quality of life.
Step 6
Ongoing safety monitoring
Throughout the trial the study team will monitor for serious liver events such as decompensation, need for transplant, development of large varices, or progression to advanced disease stages. any occurrence will be recorded as part of the primary outcome.

Who can join the trial?

8 criteria

Be able to read and understand the written study information, sign the consent form, and agree to follow the study rules. Informed consent means you get details about the trial and you voluntarily agree to join.
Be an adult (male or female) who is at least 18 years old when you sign the consent form.
Either be taking the medicine ursodeoxycholic acid (UDCA) at the usual dose (12‑16 mg per kilogram of body weight each day) for at least 12 months with a stable dose for the last 6 months, and plan to keep that dose during the trial, or be unable to tolerate UDCA and have not taken it in the past 3 months.
Have a confirmed diagnosis of primary biliary cholangitis (PBC) shown by at least two of the following:
- Higher than normal levels of alkaline phosphatase (ALP) for at least 6 months before screening.
- A positive test for antimitochondrial antibodies (AMA), or if AMA is negative, a positive test for other PBC‑specific antibodies (such as anti‑GP210, anti‑SP100, or antibodies against the major M2 components).
- A liver biopsy (a small tissue sample taken from the liver) that matches the features of PBC.
- Show evidence of cirrhosis (advanced liver scarring) and have ALP above the normal range and total bilirubin no more than five times the normal limit. Cirrhosis can be proven by:
  - A previous liver biopsy that reported cirrhosis (stage 4 or fibrosis score 3), or
  - A liver stiffness measurement (using a FibroScan device) greater than 15 kPa together with either imaging that shows a nodular liver and an enlarged spleen, or a low platelet count (fewer than 140 × 10⁹ per liter). Platelets are cells that help blood clot.

Who cannot join the trial?

17 criteria

Drinking too much alcohol in the past five years: 2 standard drinks per day for men (or 14 drinks per week) or 1 standard drink per day for women (or 7 drinks per week) for at least three months straight. A standard drink is roughly a 12‑ounce beer, a 4‑ounce glass of wine, or a 1‑ounce shot of hard liquor.
Having advanced liver scarring classified as Child‑Pugh B (score ≥ 7) or Child‑Pugh C (score ≥ 10), which indicates more severe liver disease.
Having a blood‑test score called MELD‑Na of 12 or higher, a number that shows serious liver dysfunction.
Having chronic hepatitis B infection (a positive hepatitis B surface antigen test).
Having chronic hepatitis C infection (a positive hepatitis C antibody test plus detectable virus RNA).
Having primary sclerosing cholangitis, a disease that narrows the tubes (bile ducts) that carry liver fluid.
Having liver disease caused mainly by alcohol (alcohol‑associated liver disease).
Having an overlap of autoimmune hepatitis and primary biliary cholangitis, meaning both autoimmune liver conditions are present together.
Having hemochromatosis, a condition where the body stores too much iron.
Having metabolic dysfunction‑associated steatohepatitis, a type of fatty liver disease diagnosed by a liver biopsy.
Having α‑1 antitrypsin deficiency, a genetic disorder that can affect the liver.
Having had a liver transplant or being on a waiting list for a liver transplant.
Having fluid buildup in the abdomen (ascites) that requires treatment.
Having bleeding from enlarged veins in the esophagus or stomach, or having had procedures to stop that bleeding (such as banding or a TIPS placement).
Having moderate or severe brain confusion from liver disease (hepatic encephalopathy grade 2 or higher) or a history of spontaneous bacterial infection in the abdominal fluid.
Having hepatorenal syndrome, a type of kidney failure caused by severe liver disease.
Having known or suspected liver cancer or other cancers of the bile ducts, shown by a blood marker called AFP higher than 20 ng/mL.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands
Hippokration Hospital
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Athens, Greece
Hospital Clinic De Barcelona
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Barcelona, Spain

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Investigated drugs

Saroglitazar Magnesium is an oral tablet being tested as the active treatment in this study. It belongs to a class of medicines that help regulate certain fats and sugars in the body. In the trial, participants with primary biliary cholangitis take the tablet each day to see if it can reduce the risk of worsening liver disease and improve clinical outcomes. The drug is considered an orphan medication, meaning it is intended for a rare condition and has special regulatory status.

SAROGLITAZAR HEMIMAGNESIUM

What is already known about the treatment

Placebo
The tablets look the same as the active drug but contain no saroglitazar magnesium, and are taken by mouth once daily. They are used in clinical studies to compare the effects of the real medicine with an inactive pill. The placebo has no therapeutic effect and is not a marketed medication. It serves only as a control in the trial.
Saroglitazar Magnesium
The drug is given as an uncoated tablet taken orally once daily at a dose of 1 mg. It is an approved medication for a rare liver disease called primary biliary cholangitis and is listed in medical literature as a dual PPARα/γ agonist. It works by activating specific receptors that help lower fat and sugar levels in the liver and improve bile flow. Pharmacologically it belongs to the class of peroxisome proliferator‑activated receptor agonists and is considered an orphan drug.

Investigated diseases

Primary Biliary Cholangitis (PBC) - Primary Biliary Cholangitis is a chronic autoimmune condition that gradually damages the small bile ducts inside the liver. The loss of these ducts causes bile to build up, leading to inflammation and scarring of liver tissue. As scarring increases, the liver can become cirrhotic and its ability to function declines. People may later develop fluid buildup in the abdomen, enlarged veins in the esophagus, or require a liver transplant. Early symptoms often include fatigue and itching before significant liver changes are detected.