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SAROGLITAZAR HEMIMAGNESIUM

SAROGLITAZAR HEMIMAGNESIUM is being studied in clinical trials for people with primary biliary cholangitis, a long-term liver disease. The trial data here focus on safety, tolerability, and how well the treatment works compared with placebo. The main outcome is a biochemical response measured after 52 weeks.

Table of contents

Trial overview

The source data include one interventional study 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 focused on patients with PBC.[1] The source data do not give more detailed entry rules, so the available information only confirms the disease group studied.[1]

What was tested

The study compared SAROGLITAZAR HEMIMAGNESIUM with placebo, which is a look-alike tablet that does not contain the active study drug.[1] The study brief says it aimed to show superiority of Saroglitazar Magnesium Optimal Dose 1 mg once daily over placebo for biochemical response at Week 52.[1]

The trial record also lists Saroglitazar Magnesium 2 mg orally in the intervention section.[1] The source data do not explain the difference between these dose descriptions, so this article only reports that both dose information and a placebo comparator were recorded in the trial data.[1]

Main endpoint and how it was measured

The primary outcome was the proportion of subjects with a biochemical response at Week 52.[1] This response was defined by a composite endpoint, which means more than one blood test result had to meet the study rules at the same time.[1]

The blood test rules were: ALP less than 1.67 times the upper limit of normal, at least a 15% decrease in ALP from baseline, and total bilirubin at or below the upper limit of normal, or direct bilirubin at or below the upper limit of normal in people with known Gilbert’s syndrome.[1] In simple terms, the study checked whether liver-related blood tests improved enough after 52 weeks.[1]

Trial design and phase

This was a Phase 4 interventional trial.[1] Phase 4 studies are later-stage studies and are often used to learn more about a treatment in patients after earlier research has already been done.[1]

The study was completed and enrolled 196 participants.[1] The source data do not provide more details about randomization, blinding, or visit schedule, so those features are not described here.[1]

What is known from the source data

The source data provided for this article describe the study design, target condition, phase, enrollment, and main endpoint, but not the final outcome results.[1] Because of that, this article focuses on what the trial was planned to measure rather than on a reported efficacy result.[1]

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

FAQ

  • What condition is being studied with SAROGLITAZAR HEMIMAGNESIUM? The trial is studying primary biliary cholangitis, often called PBC. This is a long-term liver disease.
  • Who could take part in the trial? The trial enrolled people with primary biliary cholangitis. The source data do not give more detailed entry rules.
  • What was the trial trying to find out? It aimed to assess safety, tolerability, and efficacy. In simple terms, it looked at whether the treatment could be used safely and whether it helped people.
  • What phase was this study? This was a Phase 4 trial. Phase 4 studies are done after a treatment has already been studied earlier and are used to learn more in a real-world setting.
  • What result did the study measure? The main result was a biochemical response at Week 52. It used blood test markers called ALP and total bilirubin to see whether people met the response criteria.

Igangværende kliniske forsøg for SAROGLITAZAR HEMIMAGNESIUM

  • Afprøvning af lægemidlet Saroglitazar Magnesium til behandling af primær biliær kolangitis hos patienter, hvor standardbehandling ikke virker godt nok

    Rekrutterer ikke

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Island

Ordliste

  • Primary biliary cholangitis (PBC): A long-term liver disease. The trial studied people with this condition.
  • Safety: How well a treatment can be used without causing unacceptable harm. The trial looked at this as one of its goals.
  • Tolerability: How well people can take a treatment and handle it. This was part of the study aim.
  • Efficacy: How well a treatment works. The trial compared SAROGLITAZAR HEMIMAGNESIUM with placebo to see if it was effective.
  • Placebo: A tablet that looks like the study drug but does not contain the active medicine. It is used for comparison.
  • Phase 4: A later stage of clinical research. It usually studies a treatment after earlier testing has already been done.
  • Biochemical response: An improvement seen in blood test results. In this trial, it was the main outcome being measured.
  • ALP: A blood test called alkaline phosphatase. The trial used it as part of the main response measure.
  • Total bilirubin: A blood test that helps show how the liver is working. It was part of the trial’s main endpoint.
  • Week 52: The time point 52 weeks after the start of the study, or about 1 year.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/afprovning-af-laegemidlet-saroglitazar-magnesium-til-behandling-af-primaer-biliaer-kolangitis-hos-patienter-hvor-standardbehandling-ikke-virker-godt-nok/