Evaluate the Efficacy and Safety of Saroglitazar Magnesium

Primary Investigator

Administratively Closed

18 years - 75 years

All

Phase 2/3

5 participants needed

2 Locations

Brief description of study

This study aims to evaluate the safety and effectiveness of Saroglitazar Magnesium Optimal Dose (1 or 2 mg) for treating primary biliary cholangitis.

Participants will receive either Saroglitazar at 1mg dose, Saroglitazar at a 2mg dose, or a placebo and take this medication daily for 1 year.

You may be eligible for this study if you meet the following criteria:

Inclusion Criteria:

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.
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
The subjects should have positive anti-mitochondrial antibodies (AMA) titer OR if AMA is negative or in low titer (< 1:80), then the subjects should have 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])
Liver biopsy consistent with PBC
ALP ≥ 1.67 x ULN at both Visits 1 and 2 and with < 30% variance between the levels from Visit 1 to Visit 2
Total bilirubin < 2 x ULN at screening (Visit 1)
Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria:

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).
History or presence of other concomitant liver diseases at screening
Cirrhosis with complications
Clinically silent compensated cirrhosis
Medical conditions that may cause non-hepatic increases in ALP
Use of thiazolidinediones or fibrates (within 12 weeks prior to screening)
Use of drugs that are known cytochromes P2C8 (CYP2C8) inhibitors/substrate within 4 weeks prior to screening
History of bowel surgery
Type 1 diabetes mellitus
Unstable cardiovascular disease
History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, coagulation disorders, or screening blood tests that, in the opinion of the Investigator, indicate altered coagulability
An uncontrolled thyroid disorder
History of myopathies or evidence of active muscle disease
Contact study team for more details on inclusions and exclusions

Updated on 01 Aug 2024. Study ID: 13848, GI-ZYDUS-SARO-21-001-EPICS-III