Not recruiting

Study on the Safety and Effectiveness of Saroglitazar Magnesium for Patients with Primary Biliary Cholangitis

InvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study will test a medication called Saroglitazar Magnesium, which is taken as uncoated tablets. The purpose of the study is to evaluate the effectiveness and safety of Saroglitazar Magnesium in treating PBC.

Participants in the study will be randomly assigned to receive either Saroglitazar Magnesium or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about 52 weeks, during which participants will take the medication once daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The main goal is to see if Saroglitazar Magnesium can improve certain liver function tests, specifically the levels of alkaline phosphatase (ALP) and bilirubin, which are indicators of liver health.

By the end of the study, researchers hope to determine if Saroglitazar Magnesium is more effective than the placebo in improving liver function in people with PBC. This information could help in developing better treatments for those living with this chronic liver disease.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include age between 18 and 75, a confirmed diagnosis of primary biliary cholangitis (PBC), and specific liver function test results.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication, saroglitazar magnesium, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
Step 3
Medication administration
The study medication, saroglitazar magnesium, is taken orally in the form of uncoated tablets.
The dosage is 1 mg once daily, and the treatment duration is 52 weeks.
Step 4
Regular monitoring
Participants undergo regular monitoring throughout the study. This includes blood tests to measure liver function and other health indicators.
Monitoring occurs at specified intervals: Weeks 4, 8, 16, 24, and 52.
Step 5
Evaluation of outcomes
The primary outcome is assessed at Week 52, focusing on liver function improvements, specifically the levels of alkaline phosphatase (ALP) and bilirubin.
Secondary outcomes include changes in itch severity, quality of life, and other liver and lipid parameters at various points during the study.
Step 6
Completion of study
At the end of the 52-week period, participants complete the study. Final assessments are conducted to evaluate the overall effects of the treatment.

Who can join the trial?

8 criteria

Participants must be **males or females** aged between **18 and 75 years**.
Participants should have been taking **ursodeoxycholic acid (UDCA)**, a medication for liver disease, for at least **12 months** at a proper dose and have maintained a stable dose for **6 months** before the screening. Alternatively, participants who cannot tolerate UDCA and have not taken it for at least **3 months** before screening can also participate.
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Participants must have a history of confirmed **Primary Biliary Cholangitis (PBC)**, a liver condition, based on specific guidelines. This should be shown by at least two of the following:
- History of high **ALP levels** (a liver enzyme) for at least **6 months** before screening.
- Positive test for **anti-mitochondrial antibodies (AMA)** or specific PBC antibodies if AMA is negative.
- A **liver biopsy** that matches PBC.
- Participants must have **ALP levels** that are at least **1.67 times the upper limit of normal (ULN)** at both initial visits, with less than **30% variance** between these levels.
- Participants must have **total bilirubin** levels that are less than **2 times the ULN** at screening. **Bilirubin** is a substance made by the liver.
- Participants must provide **written informed consent** and agree to follow the trial's rules.

Who cannot join the trial?

10 criteria

Patients who have other liver diseases besides Primary Biliary Cholangitis (PBC) cannot participate. PBC is a condition where the bile ducts in the liver are slowly destroyed.
Patients with severe heart problems are excluded. This means if your heart is not working well, you cannot join.
Patients who have had a liver transplant are not allowed to participate. A liver transplant is when a damaged liver is replaced with a healthy one from a donor.
Patients who are pregnant or breastfeeding cannot take part. This is to ensure the safety of both the mother and the baby.
Patients who have a history of alcohol or drug abuse in the past year are excluded. This means if you have had problems with alcohol or drugs recently, you cannot join.
Patients who are currently participating in another clinical trial are not allowed. This is to avoid any interference with the study results.
Patients with certain types of cancer are excluded. This means if you have cancer that is not well controlled, you cannot participate.
Patients with severe kidney problems cannot join. This means if your kidneys are not working well, you are not eligible.
Patients who have had a major surgery in the past 3 months are excluded. Major surgery is a big operation that requires a long recovery time.
Patients with uncontrolled diabetes are not allowed. Uncontrolled diabetes means your blood sugar levels are not stable.

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Investigated drugs

Saroglitazar Magnesium is being studied for its potential to help people with a liver condition called Primary Biliary Cholangitis (PBC). This medication is being tested to see if it can improve certain liver function markers, specifically ALP and total bilirubin, over a period of 52 weeks. The goal is to determine if this medication can provide better results than not taking any active medication.

SAROGLITAZAR HEMIMAGNESIUM

What is already known about the treatment

Saroglitazar Magnesium – This medication is administered orally in the form of a tablet, taken once daily. It is currently being studied in clinical trials for its effectiveness and safety in treating Primary Biliary Cholangitis (PBC), a liver disease. The main therapeutic indication is to improve liver function by reducing levels of alkaline phosphatase (ALP) and total bilirubin. At the molecular level, Saroglitazar Magnesium works by activating specific receptors that help regulate lipid and glucose metabolism, which can reduce inflammation and improve liver health. It is classified pharmacologically as a dual PPAR alpha/gamma agonist.

Investigated diseases

Primary Biliary Cholangitis – Primary Biliary Cholangitis (PBC) is a chronic disease that slowly damages the bile ducts in the liver. Over time, this damage can lead to a buildup of bile, which can harm liver cells and cause scarring. The disease often progresses gradually, and symptoms may not appear until significant liver damage has occurred. Common early symptoms include fatigue and itching, while later stages may involve jaundice and other liver-related issues. PBC primarily affects middle-aged women and is considered an autoimmune condition. The exact cause of PBC is not fully understood, but it involves the immune system mistakenly attacking the bile ducts.