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

Part of paid clinical trials in Marietta, Georgia.

Sponsor
Zydus Therapeutics Inc.
Study ID
NCT07216235
Phase
PHASE3
Status
Recruiting
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Conditions

  • Primary Biliary Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saroglitazar magnesium 1 mg — DRUG
    Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast
  • Placebo — DRUG
    Matching Placebo once daily, orally each morning before breakfast

Study Details

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

Key Dates

First listed
Oct 14, 2025
Start date
Mar 24, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Saroglitazar 1 mg
    Saroglitazar magnesium 1 mg, once daily, orally each morning before breakfast
  • Placebo Comparator: Placebo
    Matching placebo once daily orally each morning before breakfast

Primary Outcome Measure

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. [ Time Frame: baseline to 48 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Zydus US104MariettaGeorgia30060
Zydus US101IndianapolisIndiana46202
Zydus US105HoustonTexas77030
DeShara Emerson
[email protected]

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