Primary Biliary CholangitisPhase 3EPICS-VNCT07216235
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
A Phase 3 study testing Saroglitazar magnesium 1 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 3 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Saroglitazar magnesium 1 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Mar 2026to Nov 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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:
- 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-negative and hepatitis B surface antibody-positive) may be included in this study.
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- 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:
- 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:
- 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
- Pregnancy-related exclusions, including the following:
- If a female, who is pregnant (including a positive pregnancy test at screening), breastfeeding, intends to become pregnant, or is a woman of childbearing potential and not agreeing to use adequate contraceptive methods for the duration of the study and for at least 1 month after receiving the last dose of the IP ii. Male participants with WOCBP partners and female participants must avoid pregnancy either by true abstinence or the use of acceptable, effective contraceptive measures for the duration of the study and for at least 1 month after receiving the last dose of the IP
- Has a history or other evidence of severe illness or any other conditions, including cardiovascular, endocrine, hematological, gastrointestinal, neurological, or psychiatric disease, that, in the opinion of the investigator, would make the participant unsuitable for the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Zydus US105
Houston, Texas, 77030
DeShara Emerson, demerson@liverassoctx.com
- Recruiting
Zydus US101
Indianapolis, Indiana, 46202
Mandy Cruz, mandcruz@iu.edu
- Recruiting
Zydus US104
Marietta, Georgia, 30060
Nneka Pass, Npass@gigeorgia.com
About this study
Official title: A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Read the detailed description
A Phase 3b/4, Multicenter, Parallel Group, Double Blind, Placebo Controlled, Two Arm, Long Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Saroglitazar magnesium 1 mg, Placebo
- Keywords
- Saroglitazar Magnesium, Primary Biliary Cholangitis, PBC, clinical outcome
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saroglitazar magnesium 1 mgDrug
Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast
PlaceboDrug
Matching Placebo once daily, orally each morning before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Saroglitazar 1 mg | Experimental | Saroglitazar magnesium 1 mg, once daily, orally each morning before breakfast Receives: Drug: Saroglitazar magnesium 1 mg |
| Placebo | Placebo comparator | Matching placebo once daily orally each morning before breakfast Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 48 months
Secondary outcomes (5)
The incidence of achieving normalization of ALP, defined as ALP ≤ULN
Measured: baseline to 12 months
The incidence of achieving normalization of ALP, defined as ALP ≤ULN.
Measured: baseline to 48 months
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).
Measured: 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
Measured: baseline to 48 months
Change from baseline in 'Fatigue Domain Score' of Primary Biliary Cholangitis-40 Quality of Life Questionnaire (PBC-40)
PBC-40 Fatigue Domain Score consists of 11 question items that measure experience of fatigue over the past week from scale 1 (never) to 5 (always). The PBC-40 Fatigue Domain score ranged from 11 (best) to 55 (worst) (units on a scale). Higher scores indicated worse outcomes. Baseline was defined as the last non-missing value on or before the first dose of the randomized study medication.
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start24 Mar 2026
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, safety and efficacy study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216235
- Sponsor's protocol ID
- SARO.23.001
- Acronym
- EPICS-V
- Status last verified
- Jul 2026
- First submitted
- 5 Oct 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)
- ClinicalTrials.gov ID
- NCT07216235
- Acronym / sponsor ID
- EPICS-V / SARO.23.001
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Saroglitazar Magnesium, Primary Biliary Cholangitis, PBC, clinical outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Detailed description
A Phase 3b/4, Multicenter, Parallel Group, Double Blind, Placebo Controlled, Two Arm, Long Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, safety and efficacy study
| Arm | Type | Receives |
|---|---|---|
| Saroglitazar 1 mg | Experimental | Drug: Saroglitazar magnesium 1 mgSaroglitazar magnesium 1 mg, once daily, orally each morning before breakfast |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo once daily orally each morning before breakfast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saroglitazar magnesium 1 mgSaroglitazar magnesium 1 mg once daily, orally each morning before breakfast | Drug | Saroglitazar 1 mg |
| PlaceboMatching Placebo once daily, orally each morning before breakfast | Drug | Placebo |
Primary outcome
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
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
5 secondary outcomes
The incidence of achieving normalization of ALP, defined as ALP ≤ULN
Time frame: baseline to 12 months
The incidence of achieving normalization of ALP, defined as ALP ≤ULN.
Time frame: baseline to 48 months
To evaluate the effect of saroglitazar magnesium compared to placebo, based on event-free survival in participants with PBC
Time frame: 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
Time frame: baseline to 48 months
Change from baseline in 'Fatigue Domain Score' of Primary Biliary Cholangitis-40 Quality of Life Questionnaire (PBC-40)
Time frame: baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saroglitazar magnesium 1 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farheen Shaikh (+1-609-453-4751, fshaikh@zydustherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.