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Hope for liver disease: new drug trial targets PBC symptoms

NCT ID NCT06427395

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called saroglitazar magnesium in people with primary biliary cholangitis (PBC), a chronic liver disease. The goal is to see if the drug is safe and helps control the disease. About 102 adults who completed a previous PBC study will take the drug and be monitored for side effects and liver health improvements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

102 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

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 years and older

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. Must provide written informed consent and agree to comply with the trial protocol 2. Participated and completed SARO.21.001, the double-blind treatment phase study Exclusion Criteria: 1. Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening. 2. Participants with MELD 3.0 score of 15 or greater 3. History or presence of other concomitant liver diseases at screening: 1. Chronic hepatitis B or C virus (HBV, HCV) infection 2. Primary sclerosing cholangitis (PSC) 3. Alcoholic liver disease 4. Autoimmune hepatitis (AIH)-PBC overlap syndrome 5. Hemochromatosis 6. Non-alcoholic steatohepatitis (NASH) on historical biopsy 4. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening. 5. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening) 6. Use of other PPAR agonists (i.e., Elafibranor, Seladelpar), Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening) 7. 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 8. Unstable cardiovascular disease, including: 1. 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 2. History/current unstable cardiac dysrhythmias 3. Uncontrolled hypertension at screening 4. Stroke or transient ischemic attack in the 24 weeks before screening 9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders 10. 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 11. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening 12. Any of the following laboratory values: 1. Total bilirubin \> 3 x ULN 2. Platelets \< 50 × 103/mL 3. Albumin \< 2.8 g/dL 4. eGFR \< 45 mL/min/1.73 m2 5. ALT or AST \> 250 U/L 6. ALP \> 10 × ULN 13. Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening 14. History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening) 15. Known allergy, sensitivity or intolerance to the study medication or formulation ingredients 16. Pregnancy-related exclusions, including: 1. Pregnant/lactating female (including positive pregnancy test at screening) 2. Participants agree to avoid pregnancy 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 medication. Refer Appendix 9 Contraceptive Guidance. 17. 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, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption) 18. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11

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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

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

  • Zydus AR003

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1430CKE, Argentina

  • Zydus AR004

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Zydus AR005

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425BGC, Argentina

  • Zydus AR006

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1221ADC, Argentina

  • Zydus AR007

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

  • Zydus TR004

    Ankara, 06800, Turkey (Türkiye)

  • Zydus TR005

    Bursa, 16059, Turkey (Türkiye)

  • Zydus TR015

    Melikgazi, 38039, Turkey (Türkiye)

  • Zydus TR016

    Altındağ, 06230, Turkey (Türkiye)

  • Zydus TR017

    Cebeli, 06620, Turkey (Türkiye)

  • Zydus US001

    Indianapolis, Indiana, 46202, United States

  • Zydus US002

    Charlotte, North Carolina, 28204, United States

  • Zydus US005

    Miami, Florida, 33136, United States

  • Zydus US006

    Lakewood Rch, Florida, 34211, United States

  • Zydus US011

    Pasadena, California, 91105, United States

  • Zydus US013

    Los Angeles, California, 90048, United States

  • Zydus US016

    Charlottesville, Virginia, 22908, United States

  • Zydus US020

    Marietta, Georgia, 30060, United States

  • Zydus US022

    Aurora, Colorado, 80045, United States

  • Zydus US027

    Jacksonville, Florida, 32224, United States

  • Zydus US031

    Murray, Utah, 84107, United States

  • Zydus US033

    Seattle, Washington, 98105, United States

  • Zydus US035

    Rochester, New York, 14642, United States

  • Zydus US037

    New Haven, Connecticut, 06520, United States

  • Zydus US039

    Richmond, Virginia, 23298, United States

  • Zydus US042

    Houston, Texas, 77030, United States

  • Zydus US043

    Sacramento, California, 95817, United States

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