RecruitingPrimary Biliary Cholangitis

Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

Eligible age

18–80 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy

Sponsor: Zydus Therapeutics Inc.

You may qualify if…

✓ 1. Adults between 18 and 80 years of age (both inclusive at screening)
✓ 2. History of confirmed Primary Biliary Cholangitis diagnosis
✓ 3. 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).
✓ 4. 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
✓ 5. 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).
✓ 6. Must have given written informed consent (signed and dated).

You may not qualify if…

✕ 1. 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).
✕ 2. History or presence of other concomitant liver diseases at screening
✕ 3. 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.
✕ 4. 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.
✕ 5. 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).
✕ 6. 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.
✕ 7. Type 1 diabetes mellitus.
✕ 8. Unstable cardiovascular disease

Where it's recruiting

Florida

Lakewood Rch

Source: ClinicalTrials.gov · NCT07424677 · last updated 2026-09-15