Saroglitazar Magnesium 1 mg
Sponsors
Zydus Therapeutics Inc.
Conditions
Cholestatic Liver DiseaseCirrhosisDyslipidemiasHepatic ImpairmentNon-Alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisPrimary Biliary Cholangitis
Phase 1
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
RecruitingNCT05045482
Start: 2021-10-21End: 2026-12-31Target: 30Updated: 2026-09-14
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
RecruitingNCT06825559
Start: 2025-08-05End: 2026-12-31Target: 6Updated: 2026-09-14
Phase 2
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
CompletedNCT03061721
Start: 2017-04-06End: 2019-08-22Updated: 2024-10-24
Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
SuspendedNCT03097107
Start: 2017-04-06End: 2024-01-31Target: 124Updated: 2023-02-08
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
CompletedNCT05133336
Start: 2022-04-01End: 2025-05-07Updated: 2026-09-17
Phase 3
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Active, not recruitingNCT06427395
Start: 2024-07-16End: 2027-07-18Updated: 2026-05-12
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
RecruitingNCT07216235
Start: 2026-03-24End: 2032-11-01Target: 386Updated: 2026-08-04
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
RecruitingNCT07424677
Start: 2026-08-11End: 2028-11-01Target: 90Updated: 2026-09-15