A Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis

  • STATUS
    Recruiting
  • participants needed
    36
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Updated on 19 February 2024

Summary

You are invited to take part in this research project. This is because you have a disease of the liver called Primary Biliary Cholangitis (sometimes referred to as Primary Biliary Cirrhosis). The purpose this study is to test a new treatment for this condition called Saroglitazar magnesium.

Description

Saroglitazar magnesium is an experimental drug. It is dual peroxisome proliferator-activated receptor (PPAR)agonist. This means that the study drug is designed to provide anti-inflammatory effect, moderate blood sugar levels, and also help control lipids and lipoprotein metabolism (fat and how your body breakdown these fats).

The sponsor of this study, Zydus Discovery DMCC, wants to evaluate the safety and efficacy of Saroglitazar magnesium 2 mg and 4mg versus placebo in the treatment of Primary Biliary Cholangitis. This is a randomized, double-blinded clinical research study. Sometimes we do not know which treatment or which doses are best for treating a condition. To find out, we need to compare different treatments. People are put into groups and each group is assigned a different treatment. Then we check to see which treatment appears to work better. To try to make sure the groups are the same, each participant is put into a group by chance, like the flip of a coin (random). You will have a 2 in 3 chance of receiving the active study drug.

The research study being blinded means that neither you nor your study doctor will know which treatment you are receiving. However, in certain circumstances your study doctor can find out which treatment you are receiving by asking the sponsor.

If you qualify, you will randomly (like the flip of a coin) receive Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg, or placebo, by mouth once daily in the morning before breakfast without food for 16 weeks. A total of approximately 36 subjects will be randomized. You must be willing to attend all the visits to the doctor. Different procedures will be performed at each visit. 
The research study consists of a Screening Phase (Visits 1 and 2) that lasts up to 42 days, a Treatment Phase (Visits 3 through 7) that will last 112 days, and a safety follow-up 4 weeks later. The research study lasts about 26 weeks. 

FAQ


Details
Condition PBC,Liver disease,primary biliary choloangitis
Age 18years - 75years
Clinical Study Identifier827334
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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