CompletedPhase 2/3

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

United States196 participantsStarted 2022-04-01

Plain-language summary

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

Age range18 Years – 75 Years

SexALL

See this in plain English?

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

✓. Males or females, between 18 and 75 years of age, both inclusive at screening.
✓. 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.
✓. 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:
✓. ALP ≥ 1.67 x ULN at both Visits 1 and 2 and \< 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.

✕. 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:
✕. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: However, If the subject has been treated for the HCV infection and has been cured for a duration of more than 2 years from screening, such subjects can be enrolled in the study)
✕. Primary sclerosing cholangitis (PSC).
✕. Alcoholic liver disease.
✕. Autoimmune hepatitis (AIH) indicative of PBC with overlap syndrome.
✕.Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years, including known cancers.
✕.Use of thiazolidinediones or fibrates (within 12 weeks prior to screening). 7.Use of obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (Note: Prednisone dose should not be 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).

Proportion of subjects with biochemical response based on the composite endpoints of ALP and total bilirubin

Timeframe: From baseline to week 52

NCT IDNCT05133336

SponsorZydus Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-30

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

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

✓. Males or females, between 18 and 75 years of age, both inclusive at screening.
✓. 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.
✓. 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:
✓. ALP ≥ 1.67 x ULN at both Visits 1 and 2 and \< 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.

✕. 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:
✕. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: However, If the subject has been treated for the HCV infection and has been cured for a duration of more than 2 years from screening, such subjects can be enrolled in the study)
✕. Primary sclerosing cholangitis (PSC).
✕. Alcoholic liver disease.
✕. Autoimmune hepatitis (AIH) indicative of PBC with overlap syndrome.
✕.Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years, including known cancers.
✕.Use of thiazolidinediones or fibrates (within 12 weeks prior to screening). 7.Use of obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (Note: Prednisone dose should not be 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).