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SAROGLITAZAR HEMIMAGNESIUM

Clinical trials are studying SAROGLITAZAR HEMIMAGNESIUM in people with Primary Biliary Cholangitis (PBC). These studies look at safety, tolerability, and how well the treatment works compared with placebo. The trial data here focus on adults with PBC.

Table of Contents

Trial overview

The source data describes one interventional trial of SAROGLITAZAR HEMIMAGNESIUM in people with Primary Biliary Cholangitis (PBC), a long-term liver disease.[1] The study was called EPICS-III and was designed to evaluate safety, tolerability, and efficacy.[1]

Who was studied

The trial included patients with PBC.[1] The source does not provide more detailed participation rules such as age range, lab limits, or other entry requirements.[1]

What was tested

The study compared SAROGLITAZAR HEMIMAGNESIUM with placebo, which is a look-alike treatment without the active study drug.[1] The intervention list in the source also notes a 2 mg oral dose, while the brief summary states an optimal dose of 1 mg once daily; the source data does not explain this difference further.[1]

Main endpoint and study goals

The main endpoint was the proportion of subjects with a biochemical response at Week 52.[1] This response was based on blood test targets for ALP and total bilirubin, including ALP below 1.67 times the upper limit of normal, at least a 15% drop in ALP from baseline, and bilirubin within the normal range or direct bilirubin within the normal range for people with known Gilbert’s syndrome.[1]

Study design and phase

This was a Phase 4 interventional study.[1] Phase 4 studies are usually done later in clinical development and help researchers learn more about a treatment in real patients.[1] The study enrolled 196 participants and was completed.[1]

Results reported in the source

The provided source gives the study goal and design, but it does not include detailed outcome results.[1] Because of that, the article can describe what the trial measured, but not whether the treatment met the endpoint.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05133336 Phase 4 Primary Biliary Cholangitis (PBC) Completed 196

FAQ

  • What condition is being studied in the SAROGLITAZAR HEMIMAGNESIUM trial? The trial is studying Primary Biliary Cholangitis, also called PBC. This is a long-term liver disease.
  • Who took part in the trial? The trial included people with PBC. The source data does not give more detailed participant rules such as age limits or lab requirements.
  • What phase was the trial? This was a Phase 4 trial. Phase 4 studies are done after a treatment is already in use and help learn more about its effects in real patients.
  • What was the trial trying to measure? The main goal was to measure biochemical response, which means improvement in blood test markers. The trial looked at ALP and total bilirubin at Week 52.
  • Was SAROGLITAZAR HEMIMAGNESIUM compared with anything else? Yes. The trial compared SAROGLITAZAR HEMIMAGNESIUM with placebo, which looks like a treatment but has no active study drug.

Ongoing Clinical Trials on SAROGLITAZAR HEMIMAGNESIUM

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Iceland

Glossary

  • Primary Biliary Cholangitis (PBC): A long-term disease that affects the bile ducts in the liver and can lead to liver problems over time.
  • Phase 4: A late-stage clinical trial done after a treatment is already available, to learn more about how it works in everyday patients.
  • Placebo: A look-alike treatment with no active study drug. It is used to compare results fairly.
  • Interventional study: A study in which researchers give a treatment and then measure what happens.
  • Safety: How well a treatment is tolerated and whether it causes problems during the study.
  • Tolerability: How easy a treatment is for people to take and how well they handle it.
  • Efficacy: How well a treatment works for the condition being studied.
  • Biochemical response: Improvement seen in blood tests that show how the body or an organ is responding to treatment.
  • ALP: Alkaline phosphatase, a blood test marker that can be higher in some liver diseases.
  • Total bilirubin: A blood test that measures a yellow substance made when red blood cells break down. It can help show how the liver is working.
  • ULN: Upper limit of normal. This is the highest value considered normal for a lab test.
  • Week 52: The 52-week point in a study, which is about one year after the start.

References