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Saroglitazar hemimagnesium normalizes alkaline phosphatase in primary biliary cholangitis patients with incomplete response or intolerance to ursodeoxycholic acid

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What is this trial about?

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

Primary Biliary Cholangitis is a rare, long‑term liver disease that damages the small bile ducts, causing a buildup of bile. The usual medicine for this condition is Ursodeoxycholic acid, but some patients do not respond well or cannot tolerate it. This study is testing a new oral tablet called Saroglitazar Magnesium, taken once daily.

The purpose of the study is to determine whether the drug can bring the level of ALP, a blood enzyme that reflects liver health, back to normal. Participants will be randomly assigned to receive either the active tablet or a look‑alike placebo for about one year, with regular clinic visits for safety checks and blood tests.

The trial is a Phase 3 investigation, meaning it is a large‑scale test after earlier safety studies. Throughout the study, doctors will monitor how well the treatment works by measuring the enzyme level and will watch for any side effects. The information gathered will help decide if the medication should be used for people with this condition.

The research process

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

  1. Step 1

    Baseline Assessment and Randomization

    You will attend a baseline visit where blood will be drawn to measure your alkaline phosphatase (ALP) level and other routine tests. ALP is an enzyme that indicates liver function; the upper limit of normal (ULN) is the highest value considered normal.

    Based on the baseline results, you will be randomly assigned to receive either saroglitazar magnesium 1 mg tablet or a placebo tablet that looks identical. The assignment is double‑blind, meaning neither you nor the study staff will know which tablet you receive.

  2. Step 2

    Start of Study Medication

    You will begin taking one tablet each day by mouth. The tablet contains either saroglitazar magnesium 1 mg or no active drug (placebo). The dosage is once daily, taken at the same time each day, for a total period of 52 weeks.

  3. Step 3

    First Follow‑Up Visit (Week 4)

    At week 4, you will return for a follow‑up visit. Blood will be drawn again to check your ALP level and to see whether it has decreased by at least 15 % from the baseline value and is now at or below the ULN.

    The visit also provides an opportunity to report any side effects you may have experienced while taking the study tablet.

  4. Step 4

    Ongoing Daily Treatment (Weeks 5–51)

    You will continue to take the assigned tablet once daily for the remaining weeks. No additional clinic visits are required unless you experience problems, but you may be asked to attend occasional safety checks as directed by the study protocol.

  5. Step 5

    Final Assessment (Week 52)

    At week 52, you will have a final study visit. Blood will be drawn to measure ALP again and to determine whether the primary goal—ALP at or below the ULN with at least a 15 % reduction from baseline—has been achieved.

    Additional blood tests will be used to calculate the UK‑PBC and GLOBE scores, which are tools that estimate disease activity and long‑term prognosis in primary biliary cholangitis (PBC).

    You will also discuss any remaining side effects and receive information about the next steps after the study ends.

  6. Step 6

    End of Study

    After the week 52 visit, your participation in the trial is complete. You will no longer receive the study tablet, and you may discuss with your regular doctor how to continue managing your PBC.

Who can join the trial?

6 criteria

  • Be between 18 and 80 years old.
  • Have a confirmed diagnosis of Primary Biliary Cholangitis (PBC) according to the AASLD/EASL guidelines (these are accepted medical recommendations for this condition).
  • Have a blood level of alkaline phosphatase (ALP) that is higher than the normal upper limit (ULN) but less than 1.67 × ULN, measured on two screening visits with less than 30% variation.
  • Either be taking a stable dose of ursodeoxycholic acid (UDCA) for at least 6 months, or, if you cannot tolerate the medicine, have not taken it for at least 3 months.
  • Have a total bilirubin level in the blood that is no more than 2 × the normal upper limit (ULN).
  • Provide written informed consent agreeing to take part in the study.

Who cannot join the trial?

6 criteria

  • You cannot join if you have other liver diseases such as hepatitis B (HBV), hepatitis C (HCV), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), alcoholic liver disease, or metabolic dysfunction‑associated steatohepatitis (MASH).
  • You cannot join if you have advanced liver disease or liver failure, measured by a Child‑Pugh score of B or C (7 or higher) or a MELD score of 12 or higher.
  • You cannot join if you are taking medications that are not allowed for the study, such as obeticholic acid (OCA), fibrates, drugs that activate PPAR receptors, or any immunosuppressant medicines.
  • You cannot join if you have significant heart or blood vessel disease.
  • You cannot join if your laboratory test results show severe abnormalities, including a platelet count lower than 100 × 10⁹/L, a kidney function estimate (eGFR) below 45 mL/min/1.73 m², liver enzyme levels (ALT or AST) higher than 250 U/L, or a blood clotting test (INR) of 1.7 or higher.
  • You cannot join if you are currently pregnant or breastfeeding.
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Investigated drugs

Saroglitazar Magnesium is an oral tablet taken once a day. In this study it is being tested to see if it can lower the level of an enzyme called alkaline phosphatase (ALP) in the blood of people who have primary biliary cholangitis (PBC) and who do not respond well or cannot tolerate the usual medicine, ursodeoxycholic acid (UDCA). The tablet contains the active ingredient saroglitazar hemimagnesium and is designed for patients with higher than normal ALP but not extremely high levels. The drug is classified as an orphan drug, meaning it is intended for a rare condition.

What is already known about the treatment

Saroglitazar Magnesium - It is taken as an oral uncoated tablet, 1 mg once daily. The drug is already approved in some countries for treating abnormal blood fats and has been studied in several clinical trials, making it a well‑known compound in medical literature. It is being investigated to help patients with primary biliary cholangitis who do not respond well to standard therapy. Saroglitazar works by activating the body’s PPAR‑α and PPAR‑γ receptors, which control genes that manage fat breakdown and reduce liver inflammation, and it is classified as a dual PPARα/γ agonist (a lipid‑modifying agent).

Investigated diseases

Primary Biliary Cholangitis - Primary Biliary Cholangitis is a chronic liver disease in which the immune system gradually damages the small bile ducts. This damage reduces the flow of bile, causing bile to accumulate in the liver. The buildup leads to inflammation and scarring of liver tissue over time. Early signs often include fatigue and itching. As scarring progresses, the liver can become enlarged and its ability to filter blood may decline.
Trial detailsLast updated 8 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526680-38-00Protocol codeSARO.24.001Estimated enrolment82 patientsSponsorZydus Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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