Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
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 documented evidence of cirrhosis and has ALP >ULN and TB ≤5 × ULN
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
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)
Parallel
Saroglitazar magnesium 1 mg
DrugSaroglitazar magnesium 1 mg once daily, orally each morning before breakfast
Placebo
DrugMatching Placebo once daily, orally each morning before breakfast
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 from randomization to the first occurrence of any of the following clinical outcome events: * Liver decompensation * Change in the Model for End-Stage Liver Disease-Na score to ≥15, measured on 2 consecutive occasions, performed at least 2 weeks apart, without the presence of any competing etiologies. * Liver transplant. * Death (liver- and nonliver-related). * Progression to clinically significant portal hypertension, defined as the development of large varices (\>5 mm in diameter) in participants who had no varices at baseline * Progression to Child-Pugh-Turcotte C, defined as Child-Pugh-Turcotte score ≥10, measured at 2 consecutive time points at least 4 weeks apart with no competing etiologies
The incidence of achieving normalization of ALP, defined as ALP ≤ULN
The incidence of achieving normalization of ALP, defined as ALP ≤ULN.
To evaluate the effect of saroglitazar magnesium compared to placebo, based on event-free survival in participants with PBC
Time from randomization to the first occurrence of any of the following clinical outcome events: * Liver decompensation, as defined in the primary endpoint. * Liver transplant * Death (liver- and non liver-related).
The percentage of participants with stabilization in Total Bilirubin (TB) (ie, no increase), defined as TB ≤1 × ULN or increase from baseline ≤0.1 × ULN
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