Primary Biliary CholangitisPhase 3EPICS-IVNCT07424677
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
A Phase 3 study testing Saroglitazar Magnesium 1 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 1 site in United States.
Trial summary
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to Nov 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 80 years of age (both inclusive at screening)
- History of confirmed Primary Biliary Cholangitis diagnosis
- Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit).
- Average Alkaline Phosphatase at both screening Visits 1 and 2: > 1× Upper Limit of Normal and < 1.67× Upper Limit of Normal, and < 30% variance between both levels
- Total bilirubin ≤ 2 x Upper Limit of Normal at screening (Visit 1), unless there is a prior diagnosis of Gilbert's syndrome. For participants with Gilbert's syndrome, direct bilirubin is to be ≤ 2 x Upper Limit of Normal at screening (Visit 1).
- Must have given written informed consent (signed and dated).
Who cannot join
- Consumption of 14 or more standard alcohol drinks per week if male and 7 or more standard alcohol drink per week if female for at least 3 consecutive months (i.e., 12 consecutive weeks) within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
- History or presence of other concomitant liver diseases at screening
- Cirrhosis with complications, including history or presence of the following: spontaneous bacterial peritonitis, hepatocellular carcinoma, ascites requiring treatment, encephalopathy, known large esophageal varices, or history of variceal bleeding within one year prior to screening or history of hepatorenal syndrome.
- Medical conditions that may cause non-hepatic increases in Alkaline Phosphatase (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers.
- Use of obeticholic acid, thiazolidinediones, fibrates (i.e. fenofibrate, bezafibrate, pemafibrate), other Peroxisome Proliferator-Activated Receptor agonists (i.e., seladelpar, elafibranor, lanifibranor), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids (equivalent to prednisone dose more than 10 mg per day); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening).
- History of bowel surgery (gastrointestinal [bariatric] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant or listed for orthotopic liver transplant.
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- Type 1 diabetes mellitus.
- Unstable cardiovascular disease
- History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, coagulation disorders, or screening blood tests that, in the opinion of the Investigator, indicate clinically significant altered coagulability (e.g., Prothrombin Time, International Normalized Ratio, Activated partial thromboplastin time) at screening.
- An uncontrolled thyroid disorder
- History of myopathies or evidence of active muscle disease demonstrated by Creatine Phosphokinase ≥ 5 x Upper Limit of Normal at screening.
- For subjects with elevated baseline Alanine Aminotransferase or Aspartate Aminotransferase; Alanine Aminotransferase or Aspartate Aminotransferase exceeding by more than 50% on Visit 2 compared to Visit 1.
- Any of the following laboratory values at screening:
- Platelets < 100 × 10^9/L
- Albumin < 3.5 g/dL
- Estimated Glomerular Filtration Rate < 45 mL/min/1.73 m^2
- Alanine Aminotransferase or Aspartate Aminotransferase > 250 U/L
- International Normalized Ratio greater than or equal to 1.7. However, participants with an International Normalized Ratio of 1.7 or above may be included if the elevated International Normalized Ratio is not attributable to liver disease.
- Participation in another interventional clinical study and receipt of any other investigational medication (within 12 weeks prior to randomization up to the end of the study).
- History of malignancy in the past 5 years and/or active neoplasm except resolved superficial non-melanoma skin cancer.
- Contraindications to Saroglitazar Magnesium or has any conditions affecting the ability to evaluate the effects of Saroglitazar Magnesium.
- Known allergy, sensitivity, or intolerance to the study medication, comparator, or formulation ingredients.
- Pregnancy-related exclusions, including the following:
- Pregnant/lactating female (including positive pregnancy test at screening).
- Pregnancy should be avoided by male and female participants 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 the end of the study treatment.
- History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as poorly controlled psychiatric disease, Human Immunodeficiency Virus, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).
- Cirrhosis with Child-Pugh-Turcotte Class B or C having a score of 7 or above at screening.
- Participants with Model for End Stage Liver Disease 3.0 score of 12 or above. For participants on anticoagulation medication, baseline International Normalized Ratio determination for Model for End Stage Liver Disease score calculation should take anticoagulant use into account.
- Initiation or dose adjustment of anti-pruritic drugs (e.g., cholestyramine, naltrexone, rifampin, sertraline, or any investigational therapeutic) within 1 month prior to screening and till randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
US203
Lakewood Rch, Florida, 34211
Myrlande Elichne, myrlande.elichne@fdhs.com
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
Read the detailed description
A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy of Saroglitazar Magnesium 1 mg on normalization of ALP in patients having ALP > ULN to < 1.67xULN and on Ursodeoxycholic Acid for 12 months or intolerant to Ursodeoxycholic Acid.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Saroglitazar Magnesium 1 mg, Placebo
- Keywords
- Primary Biliary Cholangitis, Saroglitazar Magnesium, PBC
- 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 Magnesium 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.
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP
Measured: Baseline to Week 52
Secondary outcomes (3)
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP
Measured: Baseline to Week 4
Change from baseline in the Global PBC Study Group (GLOBE) scores
The GLOBE score is a prognostic scoring system that incorporates various clinical and laboratory parameters to predict the long-term outcome and survival of patients with PBC.
Lower GLOBE score predicts lower risk. It is calculated from the following equation:
GLOBE score = 0.044378 × age at start of UDCA therapy + 0.93982 × ln(bilirubin × ULN at 1 year follow-up) + 0.335648 × ln(ALP × ULN at 1 year follow-up) - 2.266708 × albumin level × the lower limit of normal (LLN) at 1 year follow-up -0.002581 × platelet count per 10^9/L at 1 year follow-up +1.216865.
Measured: Baseline to Week 52
Change from baseline in the United Kingdom Primary Biliary Cholangitis (UK-PBC)
The UK-PBC risk score is a scoring system specifically developed for risk stratification and prognosis in patients with PBC. The higher the score might indicate higher risk to death or live transplantation.
UK-PBC risk score = 1 - baseline survival function∧ exp(0.0287854 × [ALP after 12 months of therapy × ULN - 1.722136304] - 0.0422873 × [{(ALT where this was available, otherwise AST, after 12 months of therapy × ULN/10)∧-1} - 8.675729006] + 1.4199 × [ln{bilirubin after 12 months of therapy × ULN/10} + 2.709607778] - 1.960303 × [albumin at baseline × LLN - 1.17673001] - 0.4161954 × [platelet count at baseline × LLN -1.873564875]).
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start11 Aug 2026
- Primary completionJul 2028 (estimated)
- Study completionNov 2028 (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
- Multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 efficacy and safety study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT07424677
- Sponsor's protocol ID
- SARO.24.001
- Acronym
- EPICS-IV
- Status last verified
- Sep 2026
- First submitted
- 26 Dec 2025
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid
- ClinicalTrials.gov ID
- NCT07424677
- Acronym / sponsor ID
- EPICS-IV / SARO.24.001
- Conditions
- Primary Biliary Cholangitis
- Keywords
- Primary Biliary Cholangitis, Saroglitazar Magnesium, PBC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 20 Feb 2026 (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.
Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
Detailed description
A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy of Saroglitazar Magnesium 1 mg on normalization of ALP in patients having ALP > ULN to < 1.67xULN and on Ursodeoxycholic Acid for 12 months or intolerant to Ursodeoxycholic Acid.
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
- Multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 efficacy and safety study
| Arm | Type | Receives |
|---|---|---|
| Saroglitazar Magnesium 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 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between 18 and 80 years of age (both inclusive at screening)
- History of confirmed Primary Biliary Cholangitis diagnosis
- Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit).
- Average Alkaline Phosphatase at both screening Visits 1 and 2: > 1× Upper Limit of Normal and < 1.67× Upper Limit of Normal, and < 30% variance between both levels
- Total bilirubin ≤ 2 x Upper Limit of Normal at screening (Visit 1), unless there is a prior diagnosis of Gilbert's syndrome. For participants with Gilbert's syndrome, direct bilirubin is to be ≤ 2 x Upper Limit of Normal at screening (Visit 1).
Key exclusion criteria (29 listed)
- Consumption of 14 or more standard alcohol drinks per week if male and 7 or more standard alcohol drink per week if female for at least 3 consecutive months (i.e., 12 consecutive weeks) within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
- History or presence of other concomitant liver diseases at screening
- Cirrhosis with complications, including history or presence of the following: spontaneous bacterial peritonitis, hepatocellular carcinoma, ascites requiring treatment, encephalopathy, known large esophageal varices, or history of variceal bleeding within one year prior to screening or history of hepatorenal syndrome.
- Medical conditions that may cause non-hepatic increases in Alkaline Phosphatase (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers.
- Use of obeticholic acid, thiazolidinediones, fibrates (i.e. fenofibrate, bezafibrate, pemafibrate), other Peroxisome Proliferator-Activated Receptor agonists (i.e., seladelpar, elafibranor, lanifibranor), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids (equivalent to prednisone dose more than 10 mg per day); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening).
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 Magnesium 1 mg |
| PlaceboMatching Placebo once daily, orally each morning before breakfast | Drug | Placebo |
Primary outcome
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP
Time frame: Baseline to Week 52
3 secondary outcomes
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP
Time frame: Baseline to Week 4
Change from baseline in the Global PBC Study Group (GLOBE) scores
Time frame: Baseline to Week 52
Change from baseline in the United Kingdom Primary Biliary Cholangitis (UK-PBC)
Time frame: Baseline to Week 52
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 15 Sep 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.
1 site 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 1 site 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 6 inclusion and 29 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (609-730-1900 ext. 221, fshaikh@zydustherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP (time frame: Baseline to Week 52). 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 15 Sep 2026.