Not Yet RecruitingPhase 3

Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

386 participantsStarted 2026-02

Plain-language summary

Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements
✓. Is an adult male or female, must be ≥18 years of age at the time of signing informed consent
✓. Is receiving ursodeoxycholic acid (UDCA) for ≥12 months with a stable dose for ≥6 months prior to screening,and expected to remain on a stable dose during the study period OR Is unable to tolerate UDCA and did not receive UDCA in the past 3 months prior to screening
✓. Has a history of confirmed PBC diagnosis, as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
✓. Has documented evidence of cirrhosis and has ALP \>ULN and TB ≤5 × ULN

Exclusion criteria

✕. Has consumption of 2 standard alcohol drinks per day (or 14 alcohol drinks per week) if male and 1 standard alcohol drink per day (or 7 alcohol drinks per week) if female for ≥3 consecutive months (12 consecutive weeks) within 5 years prior to screening
✕. Has known CPT B (having a score of ≥7) or CPT C (having a score of ≥10) cirrhosis classification at screening
✕. Has a Model for End-Stage Liver Disease (MELD)-Na score of ≥12 at screening
✕. Has a history or presence of any of the following other concomitant liver diseases at screening:
✕. Has a history or presence of clinically significant hepatic decompensation, including the following:
✕. Use of the following medications (within 12 weeks prior to screening until the randomization \[Day 1\] visit): thiazolidinediones, fibrates, OCA, methotrexate, budesonide, and other systemic corticosteroids (equivalent to prednisone dose \>10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, and nitrofurantoin); any other newly approved treatments for PBC (eg, elafibranor, seladelpar)
✕. Has elevated baseline ALT, AST, or ALP values; ALT, AST, or ALP values increasing by \>50% on Visit 2 compared to Visit 1
✕. Has any of the following laboratory values:

What they're measuring

To evaluate the effect of saroglitazar magnesium compared to placebo, based on time to the first occurrence of the defined clinical outcome events in participants with PBC.

Timeframe: baseline to 48 months

Trial details

NCT IDNCT07216235

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-11

Contact for this trial

Farheen Shaikh

609-730-1900 fshaikh@zydustherapeutics.com

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials