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Primary Biliary CholangitisPhase 2/3EPICS-IIINCT05133336

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

A Phase 2/3 study testing Saroglitazar Magnesium 1 mg and Saroglitazar Magnesium 2 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 57 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Biliary Cholangitis
What is being tested?
Saroglitazar Magnesium 1 mg and Saroglitazar Magnesium 2 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
196 participants
Where
57 sitesin 4 countries
Study dates
1 Apr 2022to 7 May 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females, between 18 and 75 years of age, both inclusive at screening.
  • Subjects on ursodeoxycholic acid (UDCA) for at least 12 months at a therapeutic dose (at least 13 mg/kg per day) and a stable dose for 6 months prior to Screening Visit and having ALP ≥ 1.67 x ULN.
  • OR Subjects who are unable to tolerate UDCA and did not receive UDCA for at least 3 months prior to the date of screening and having ALP ≥ 1.67 x ULN.
  • History of confirmed PBC diagnosis, based on American Association for the Study of Liver Disease [AASLD] and European Association for Study of the Liver [EASL] Practice Guidelines, as demonstrated by the presence of at least ≥ 2 of the following 3 diagnostic factors:
  • History of elevated ALP levels for at least 6 months prior to screening
  • Positive anti-mitochondrial antibodies (AMA) titer OR positive PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]) if AMA is negative
Show all 10Show fewer
  • Liver biopsy consistent with PBC
  • ALP ≥ 1.67 x ULN at both Visits 1 and 2 and < 30% variance between the levels from Visit 1 to Visit 2
  • Total bilirubin < 2 x ULN at screening (Visit 1)
  • Must provide written informed consent and agree to comply with the trial protocol.

Who cannot join

  • Consumption of 2 standard alcohol drinks per day if male and 1 standard alcohol drink per day if female for at least 3 consecutive months (12 consecutive weeks) within 5 year 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:
  • Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: However, If the subject has been treated for the HCV infection and has been cured for a duration of more than 2 years from screening, such subjects can be enrolled in the study)
  • Primary sclerosing cholangitis (PSC).
  • Alcoholic liver disease.
  • Autoimmune hepatitis (AIH) indicative of PBC with overlap syndrome.
Show all 31Show fewer
  • Note: The Paris criteria are commonly used to define the presence of PBC with features of AIH and have been endorsed by EASL and AASLD. According to these criteria, a diagnosis can be made in a patient with PBC as follows:
  • At least two of the following:
  • ALP > 2 x ULN or GGT > 5 x ULN. II. AMA positive III. Florid bile duct lesion on histology. AND
  • At least two of the following three features:
  • ALT > 5 x ULN. II. Immunoglobulin G serum levels > 2 x ULN or smooth muscle autoantibody positive.
  • Moderate to severe interface hepatitis on histology. e. Hemochromatosis. f. Non-alcoholic steatohepatitis (NASH) on historical biopsy. 3.Cirrhosis with complications, including history or presence of: 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.
  • 5.Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers.
  • 6.Use of thiazolidinediones or fibrates (within 12 weeks prior to screening). 7.Use of obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (Note: Prednisone dose should not be 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).
  • 9.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 (OLT) or listed for OLT.
  • 10.Type 1 diabetes mellitus. 11.Unstable cardiovascular disease, including:
  • Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the Screening Period), acute coronary syndrome in the 24 weeks before screening and throughout the Screening Period, acute myocardial infarction in the 12 weeks before screening and throughout the Screening Period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the Screening Period.
  • History/current unstable cardiac dysrhythmias. c. Uncontrolled hypertension at screening. d. Stroke or transient ischemic attack in the 24 weeks before screening. 12.History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, coagulation disorders, or screening blood tests that, in the opinion of the Investigator, indicate altered coagulability (e.g., PT, INR, aPTT) at screening.
  • 13.An uncontrolled thyroid disorder
  • Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening.
  • Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening.
  • 14.History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 x ULN at screening.
  • 15.For subjects with elevated baseline ALT or AST; ALT or AST exceeding by more than 50% on Visit 2 compared to Visit 1. Note: If the ALT or AST values on Visit 2 exceed by more than 50% from Visit 1, then a third value will be measured (within 1- 2 weeks) to assess for the trend. If the third value shows continued increase ≥ 10%, then subject is considered ineligible for randomization.
  • 16.Any of the following laboratory values at screening:
  • Platelets < 50 × 109/L b. Albumin < 2.8 g/dL c. eGFR < 45 mL/min/1.73 m2 d. ALP > 10 x ULN e. ALT or AST > 250 U/L 17.Participation in another interventional clinical study and receipt of any other investigational medication (within 12 weeks prior to randomization up to end of study).
  • 18.History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial non-melanoma skin cancer.
  • 19.Contraindications to Saroglitazar Magnesium or has any conditions affecting the ability to evaluate the effects of Saroglitazar Magnesium.
  • 20.Known allergy, sensitivity, or intolerance to the study drug, comparator, or formulation ingredients.
  • 21.Pregnancy-related exclusions, including:
  • Pregnant/lactating female (including positive pregnancy test at screening). b. Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment. Refer Appendix 8 Contraceptive Guidance 22.History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the Investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).
  • 23.Cirrhosis with Child-Pugh-Turcotte (CPT) Class B or C having score of 7 or above at screening 24.Subjects with Model for End Stage Liver Disease (MELD 3.0) score of 12 or above

Trial locations and contacts

57 sites in 4 countries.

57 sites in 4 countries

United States31 sites

  • Zydus US022

    Aurora, Colorado, 80045

  • Zydus US007

    Birmingham, Alabama, 35233

  • Zydus US002

    Charlotte, North Carolina, 28204

  • Zydus US016

    Charlottesville, Virginia, 22908

  • Zydus US014

    Cincinnati, Ohio, 45044

  • Zydus US004

    Houston, Texas, 77030

  • Zydus US042

    Houston, Texas, 77030

  • Zydus US001

    Indianapolis, Indiana, 46202

  • Zydus US034

    Iowa City, Iowa, 52242

  • Zydus US027

    Jacksonville, Florida, 32224

  • Zydus US006

    Lakewood Rch, Florida, 34211

  • Zydus US013

    Los Angeles, California, 90048

  • Zydus US038

    Manhasset, New York, 11030

  • Zydus US020

    Marietta, Georgia, 30060

  • Zydus US036

    Marrero, Louisiana, 70072

  • Zydus US005

    Miami, Florida, 33136

  • Zydus US031

    Murray, Utah, 84107

  • Zydus US037

    New Haven, Connecticut, 06510

  • Zydus US041

    Newport News, Virginia, 23602

  • Zydus US024

    Omaha, Nebraska, 68198

  • Zydus US011

    Pasadena, California, 91105

  • Zydus US015

    Philadelphia, Pennsylvania, 19141

  • Zydus US039

    Richmond, Virginia, 23298

  • Zydus US023

    Rochester, Minnesota, 55905

  • Zydus US035

    Rochester, New York, 14642

  • Zydus US043

    Sacramento, California, 95817

  • Zydus US028

    Sarasota, Florida, 34201

  • Zydus US033

    Seattle, Washington, 98105

  • Zydus US030

    St Louis, Missouri, 63104

  • Zydus US019

    Tampa, Florida, 33606

  • Zydus US021

    Tucson, Arizona, 85724

Other trials in United States

Turkey (Türkiye)15 sites

  • Zydus TR014

    Adana, 01240

  • Zydus TR016

    Altındağ, 06230

  • Zydus TR004

    Ankara, 06800

  • Zydus TR005

    Bursa, 16059

  • Zydus TR017

    Cebeli, 06590

  • Zydus TR008

    Gaziantep, 27310

  • Zydus TR009

    Istanbul, 34098

  • Zydus TR010

    Istanbul, 34098

  • Zydus TR003

    Istanbul, 34760

  • Zydus TR001

    Istanbul, 34899

  • Zydus TR002

    Izmir, 35100

  • Zydus TR013

    Izmir, 35150

  • Zydus TR011

    Kocaeli, 41380

  • Zydus TR015

    Melikgazi, 38039

  • Zydus TR006

    Mersin, 33110

Other trials in Turkey (Türkiye)

Argentina10 sites

  • Zydus AR004

    Buenos Aires, B1629ODT

  • Zydus AR009

    Buenos Aires, B7600FZO

  • Zydus AR001

    Buenos Aires, C1118AAT

  • Zydus AR013

    Buenos Aires, C1180AAX

  • Zydus AR007

    Buenos Aires, C1199ABB

  • Zydus AR006

    Buenos Aires, C1221ADC

  • Zydus AR005

    Buenos Aires, C1425BGC

  • Zydus AR012

    Buenos Aires, C1426ABP

  • Zydus AR003

    Buenos Aires, C1430CKE

  • Zydus AR010

    Santa Fe, S2002KDS

Other trials in Argentina

Iceland1 site

  • Zydus IS001

    Reykjavik, 101

Other trials in Iceland

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

Read the detailed description

A Multicenter, Randomized, Double-blind, Placebo controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis

Being tested
Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Placebo
Keywords
Saroglitazar Magnesium, Primary Biliary Cholangitis, 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

    Subjects randomized to Saroglitazar Magnesium 1 mg arm will receive Saroglitazar Magnesium 1 mg treatment for the entire treatment period up to Week 52.

  • Saroglitazar Magnesium 2 mgDrug

    Subjects randomized to Saroglitazar Magnesium 2 mg arm are switched to Saroglitazar Magnesium 1 mg treatment up to Week 52

  • PlaceboDrug

    Subjects randomized to placebo arm will receive placebo treatment for the entire treatment period up to Week 52.

Study groups in NCT05133336
Study groupRoleWhat they receive
Saroglitazar Magnesium 2 mgExperimentalSubjects who received Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast are switched to Saroglitazar Magnesium 1 mg for remaining of the treatment period
Receives: Drug: Saroglitazar Magnesium 1 mg; Drug: Saroglitazar Magnesium 2 mg
Saroglitazar Magnesium 1 mgExperimentalSaroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (52 weeks).
Receives: Drug: Saroglitazar Magnesium 1 mg
PlaceboPlacebo comparatorPlacebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (52 weeks).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with biochemical response based on the composite endpoints of ALP and total bilirubin

    ALP < 1.67 x ULN, ≥ 15% decrease in ALP relative to baseline, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN in subjects with known Gilbert's syndrome

    Measured: From baseline to week 52

Secondary outcomes (9)

  1. Proportion of subjects with complete normalization of ALP.

    ALP≤ULN

    Measured: From baseline to week 52

  2. Pruritis assessed by 5 D itch scales

    Change from baseline in 5-D itch score

    Measured: From baseline to Week 24 and Week 52

  3. Proportion of subjects with biochemical response based on the composite endpoints of ALP and total bilirubin

    ALP < 1.67 x ULN, ≥ 15% decrease in ALP, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN in subjects with known Gilbert's syndrome

    Measured: From baseline to Weeks 4, 8, 16, and 24.

  4. Proportion of subjects change from baseline in ALP

    ALP improvement of at least 15%, 30%, 40%, and 50% Absolute and percent change from baseline in ALP values

    Measured: From baseline to Weeks 24 and 52.

  5. Quality of life assessed by the PBC 40 questionnaire

    Change from baseline in quality of life (PBC 40) questionnaire domains (total score and domain score)

    Measured: From baseline to Weeks 16, 24, and 52.

  6. Improvement in liver stiffness measurement (LSM) of at least 25% relative to baseline assessed by Liver elastography/FibroScan®

    Proportion of subjects with a decrease in LSM of at least 25%

    Measured: From baseline to Weeks 24 and Week 52

  7. To effect on liver enzymes

    Change from baseline in liver enzyme parameters (ALT, AST, GGT, and total bilirubin [direct and indirect bilirubin])

    Measured: From baseline at Weeks 16, 24, and 52.

  8. The effect on liver enzymes

    Change from baseline in serum bile acids

    Measured: From baseline to week 24 and week 52

  9. The effect on lipid parameters

    Change from baseline in lipid parameters (TG, LDL-C, HDL-C, VLDL-C, total cholesterol, and non-HDL-C)

    Measured: From baseline to weeks 24 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start1 Apr 2022
  3. Primary completion30 Apr 2025
  4. Study completion7 May 2025

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, Randomized, Double-blind, Placebo controlled, Phase 2b/3 Safety and Efficacy Study . Initially, 192 subjects (64 subjects in each treatment arm) were planned be randomised in a ratio of 1:1:1 in Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, and Placebo arm, respectively. After an optimal dose selection, the subjects are randomised in 2:1 ratio of Saroglitazar Magnesium 1 mg or placebo. There would be approximately 140 evaluable subjects (90 of Saroglitazar 1 mg and 50 of placebo arm)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05133336
Sponsor's protocol ID
SARO.21.001
Acronym
EPICS-III
Status last verified
Sep 2026
First submitted
1 Nov 2021
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Saroglitazar Magnesium 1 mg and Saroglitazar Magnesium 2 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 57 sites in 4 countries.

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 10 inclusion and 31 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: finished, as of the sponsor's last update on 17 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 57 sites in United States, Turkey (Türkiye), Argentina, Iceland. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with biochemical response based on the composite endpoints of ALP and total bilirubin (time frame: From baseline to week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05133336.

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 17 Sep 2026.

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