New drug shows promise for rare liver disease in Late-Stage trial

NCT ID NCT05133336

Disease control Sponsor: Zydus Therapeutics Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tested a drug called saroglitazar magnesium in 196 adults with primary biliary cholangitis (PBC), a chronic liver disease. Participants either took the drug or a placebo to see if it improved liver function markers. The goal was to lower certain liver enzymes and bilirubin levels, which indicate better disease control.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

196 people

The number who actually took part.

Started

Apr 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females, between 18 and 75 years of age, both inclusive at screening. 2. 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. 3. 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 * Liver biopsy consistent with PBC 4. ALP ≥ 1.67 x ULN at both Visits 1 and 2 and \< 30% variance between the levels from Visit 1 to Visit 2 5. Total bilirubin \< 2 x ULN at screening (Visit 1) 6. Must provide written informed consent and agree to comply with the trial protocol. Exclusion Criteria: 1. 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). 2. History or presence of other concomitant liver diseases at screening: 1. 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) 2. Primary sclerosing cholangitis (PSC). 3. Alcoholic liver disease. 4. Autoimmune hepatitis (AIH) indicative of PBC with overlap syndrome. 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: I. 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: I. ALT \> 5 x ULN. II. Immunoglobulin G serum levels \> 2 x ULN or smooth muscle autoantibody positive. III. 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: a. 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. b. 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 1. 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. 2. 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: a. 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: a. 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

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

Contacts and locations

Locations

Zydus AR001

Buenos Aires, C1118AAT, Argentina
Zydus AR003

Buenos Aires, C1430CKE, Argentina
Zydus AR004

Buenos Aires, B1629ODT, Argentina
Zydus AR005

Buenos Aires, C1425BGC, Argentina
Zydus AR006

Buenos Aires, C1221ADC, Argentina
Zydus AR007

Buenos Aires, C1199ABB, Argentina
Zydus AR009

Buenos Aires, B7600FZO, Argentina
Zydus AR010

Santa Fe, S2002KDS, Argentina
Zydus AR012

Buenos Aires, C1426ABP, Argentina
Zydus AR013

Buenos Aires, C1180AAX, Argentina
Zydus IS001

Reykjavik, 101, Iceland
Zydus TR001

Istanbul, 34899, Turkey (Türkiye)
Zydus TR002

Izmir, 35100, Turkey (Türkiye)
Zydus TR003

Istanbul, 34760, Turkey (Türkiye)
Zydus TR004

Ankara, 06800, Turkey (Türkiye)
Zydus TR005

Bursa, 16059, Turkey (Türkiye)
Zydus TR006

Mersin, 33110, Turkey (Türkiye)
Zydus TR008

Gaziantep, 27310, Turkey (Türkiye)
Zydus TR009

Istanbul, 34098, Turkey (Türkiye)
Zydus TR010

Istanbul, 34098, Turkey (Türkiye)
Zydus TR011

Kocaeli, 41380, Turkey (Türkiye)
Zydus TR013

Izmir, 35150, Turkey (Türkiye)
Zydus TR014

Adana, 01240, Turkey (Türkiye)
Zydus TR015

Melikgazi, 38039, Turkey (Türkiye)
Zydus TR016

Altındağ, 06230, Turkey (Türkiye)
Zydus TR017

Cebeli, 06590, Turkey (Türkiye)
Zydus US001

Indianapolis, Indiana, 46202, United States
Zydus US002

Charlotte, North Carolina, 28204, United States
Zydus US004

Houston, Texas, 77030, United States
Zydus US005

Miami, Florida, 33136, United States
Zydus US006

Lakewood Rch, Florida, 34211, United States
Zydus US007

Birmingham, Alabama, 35233, United States
Zydus US011

Pasadena, California, 91105, United States
Zydus US013

Los Angeles, California, 90048, United States
Zydus US014

Cincinnati, Ohio, 45044, United States
Zydus US015

Philadelphia, Pennsylvania, 19141, United States
Zydus US016

Charlottesville, Virginia, 22908, United States
Zydus US019

Tampa, Florida, 33606, United States
Zydus US020

Marietta, Georgia, 30060, United States
Zydus US021

Tucson, Arizona, 85724, United States
Zydus US022

Aurora, Colorado, 80045, United States
Zydus US023

Rochester, Minnesota, 55905, United States
Zydus US024

Omaha, Nebraska, 68198, United States
Zydus US027

Jacksonville, Florida, 32224, United States
Zydus US028

Sarasota, Florida, 34201, United States
Zydus US030

St Louis, Missouri, 63104, United States
Zydus US031

Murray, Utah, 84107, United States
Zydus US033

Seattle, Washington, 98105, United States
Zydus US034

Iowa City, Iowa, 52242, United States
Zydus US035

Rochester, New York, 14642, United States
Zydus US036

Marrero, Louisiana, 70072, United States
Zydus US037

New Haven, Connecticut, 06510, United States
Zydus US038

Manhasset, New York, 11030, United States
Zydus US039

Richmond, Virginia, 23298, United States
Zydus US041

Newport News, Virginia, 23602, United States
Zydus US042

Houston, Texas, 77030, United States
Zydus US043

Sacramento, California, 95817, United States

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