Active — Not RecruitingPhase 3

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

United States, Argentina, Turkey (Türkiye)102 participantsStarted 2024-07-16

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Must provide written informed consent and agree to comply with the trial protocol
. Participated and completed SARO.21.001, the double-blind treatment phase study

Exclusion criteria

. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening.
. Participants with MELD 3.0 score of 15 or greater
. History or presence of other concomitant liver diseases at screening:
. Chronic hepatitis B or C virus (HBV, HCV) infection
. Primary sclerosing cholangitis (PSC)
. Alcoholic liver disease
. Autoimmune hepatitis (AIH)-PBC overlap syndrome
. Hemochromatosis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Timeframe: From baseline to 24 Months/EOT

Trial details

NCT IDNCT06427395

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-18

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials