Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Running, not enrolling · Phase 3

Conditions studied: Primary Biliary Cholangitis

In brief

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Key facts

Study ID

NCT06427395

Run by

Zydus Therapeutics Inc.

People needed

102

Starts

2024-07-16

Expected to finish

2027-07-18

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must provide written informed consent and agree to comply with the trial protocol
• Participated and completed SARO.21.001, the double-blind treatment phase study

You may not qualify if…

• 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.
• Participants with MELD 3.0 score of 15 or greater
• History or presence of other concomitant liver diseases at screening:
• Chronic hepatitis B or C virus (HBV, HCV) infection
• Primary sclerosing cholangitis (PSC)
• Alcoholic liver disease
• Autoimmune hepatitis (AIH)-PBC overlap syndrome
• Hemochromatosis
• Non-alcoholic steatohepatitis (NASH) on historical biopsy
• 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.
• Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
• 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)
• 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
• 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
• Uncontrolled hypertension at screening
• Stroke or transient ischemic attack in the 24 weeks before screening
• History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders
• 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
• History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening
• Any of the following laboratory values:
• Total bilirubin > 3 x ULN

Where it is running

• Zydus US013 — Los Angeles, California, United States
• Zydus US011 — Pasadena, California, United States
• Zydus US043 — Sacramento, California, United States
• Zydus US022 — Aurora, Colorado, United States
• Zydus US037 — New Haven, Connecticut, United States
• Zydus US027 — Jacksonville, Florida, United States
• Zydus US006 — Lakewood Rch, Florida, United States
• Zydus US005 — Miami, Florida, United States
• Zydus US020 — Marietta, Georgia, United States
• Zydus US001 — Indianapolis, Indiana, United States
• Zydus US035 — Rochester, New York, United States
• Zydus US002 — Charlotte, North Carolina, United States
• Zydus US042 — Houston, Texas, United States
• Zydus US031 — Murray, Utah, United States
• Zydus US016 — Charlottesville, Virginia, United States
• Zydus US039 — Richmond, Virginia, United States
• Zydus US033 — Seattle, Washington, United States
• Zydus AR001 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Zydus AR007 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Zydus AR006 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Zydus AR005 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Zydus AR003 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Zydus AR004 — Pilar, Buenos Aires, Argentina
• Zydus TR016 — Altındağ, Turkey (Türkiye)
• Zydus TR004 — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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