Not Yet RecruitingPhase 3

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

89 participantsStarted 2026-03

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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).
✕. History or presence of other concomitant liver diseases at screening
✕. 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.
✕. 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.
✕. 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).
✕. 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.
✕. Type 1 diabetes mellitus.
✕. Unstable cardiovascular disease

What they're measuring

The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP

Timeframe: Baseline to Week 52

Trial details

NCT IDNCT07424677

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

Farheen Shaikh

609-730-1900 fshaikh@zydustherapeutics.com

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials