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

NCT07216235 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SARO.23.001
• Study Type: interventional
• Target: 386
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Primary Biliary Cholangitis

Keywords

Saroglitazar Magnesium; Primary Biliary Cholangitis; PBC; clinical outcome

Outcome Measures

Primary Outcomes (1)

• 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, including the variceal related outcomes * 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

  baseline to 48 months

Secondary Outcomes (5)

• The incidence of achieving normalization of ALP, defined as ALP ≤ULN

  baseline to 12 months

• The incidence of achieving normalization of ALP, defined as ALP ≤ULN.

  baseline to 48 months

• To evaluate the effect of saroglitazar magnesium compared to placebo, based on event-free survival in participants with PBC

  baseline to 48 months

• 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

  baseline to 48 months

• Change from baseline in 'Fatigue Domain Score' of Primary Biliary Cholangitis-40 Quality of Life Questionnaire (PBC-40)

  baseline to 12 months

Study Arms (2)

Saroglitazar 1 mg

EXPERIMENTAL

Saroglitazar magnesium 1 mg, once daily, orally each morning before breakfast

Drug: Saroglitazar magnesium 1 mg

Placebo

PLACEBO COMPARATOR

Matching placebo once daily orally each morning before breakfast

Drug: Placebo

Interventions

Saroglitazar magnesium 1 mg DRUG

Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast

Saroglitazar 1 mg

Placebo DRUG

Matching Placebo once daily, orally each morning before breakfast

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant must meet all of the following criteria to be enrolled in this study:
• 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:
• i. A history of elevated ALP levels for ≥6 months prior to screening ii. Positive antimitochondrial antibodies (AMA) titer OR if AMA is negative, then positive PBC-specific antibodies iii. Liver biopsy consistent with PBC diagnosis
• Has documented evidence of cirrhosis and has ALP \>ULN and TB ≤5 × ULN

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• 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:
• i. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: If a participant has been treated for the HCV infection and has been cured for a duration of \>2 years prior to screening, they can be enrolled in the study. Participants who have seroconverted \[hepatitis B surface antigen AND hepatitis B antigen is negative\] may be included in this study.) ii. Primary sclerosing cholangitis iii. Alcohol-associated liver diseases iv. Autoimmune hepatitis (AIH)-PBC overlap syndrome v. Hemochromatosis vi. Metabolic dysfunction-associated steatohepatitis on historical biopsy vii. α-1 antitrypsin deficiency
• Has a history or presence of clinically significant hepatic decompensation, including the following:
• i. Liver transplantation or currently placed on a liver transplant list ii. Complications of cirrhosis iii. Hepatorenal syndrome (Type I or II) iv. Known or suspected hepatocellular carcinoma or other hepatobiliary malignancies
• 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:
• i. TB \>5 × ULN ii. Platelets \<50 × 10\^9/L iii. Albumin \<2.8 g/dL iv. ALP \>10 × ULN v. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 vi. ALT or AST \>5 × ULN vii. International normalized ratio (INR) \>1.7 in the absence of anticoagulant therapy viii. CPK \> 2x ULN
• Has participated in another interventional clinical study and received any other investigational medication or medical device within 30 days or 5 half lives, whichever is longer, prior to screening
• Has a history of malignancy in the past 5 years and/or active neoplasm, which may diminish life expectancy (except resolved superficial nonmelanoma skin cancer, carcinomas in situ, or other stable, relatively benign conditions prior to screening)
• Has a known allergy, hypersensitivity, or intolerance to saroglitazar or any of the formulation ingredients

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

saroglitazar

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Farheen Shaikh

CONTACT

609-730-1900; fshaikh@zydustherapeutics.com

Deven Parmar

CONTACT

609-703-1900; dparmar@zydustherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, safety and efficacy study

Study Record Dates

• First Submitted: October 5, 2025
• First Posted: October 14, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: February 18, 2026

Record last verified: 2026-02