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ClinicalTrials.gov public records Last synced Nov 15, 2026, 1:43 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Showing 1–17 of 17 matching trials from the live ClinicalTrials.gov search.

Filters: Intervention: Saroglitazar Clear all

Conditions: Primary Biliary Cirrhosis
Interventions: Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg, Placebo Oral Tablet; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 37 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2020
U.S. locations: 9
States / cities: Pasadena, California • Miami, Florida • Marietta, Georgia + 5 more

Conditions: Primary Biliary Cholangitis
Interventions: Saroglitazar Magnesium 1 mg; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 102 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2027
U.S. locations: 17
States / cities: Los Angeles, California • Pasadena, California • Sacramento, California + 14 more

Conditions: Primary Biliary Cholangitis
Interventions: Saroglitazar magnesium 1 mg, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 386 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2032
U.S. locations: 3
States / cities: Marietta, Georgia • Indianapolis, Indiana • Houston, Texas

Conditions: Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
Interventions: Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 80 Years
Enrollment: 30 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2021 – 2026
U.S. locations: 1
States / cities: Indianapolis, Indiana

Conditions: Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Interventions: Saroglitazar magnesium 1 mg, Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg, Placebos; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 106 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2019
U.S. locations: 18
States / cities: Chula Vista, California • Los Angeles, California • Montclair, California + 15 more

Conditions: Nonalcoholic Steatohepatitis, Fibrosis
Interventions: Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 189 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2025
U.S. locations: 101
States / cities: Birmingham, Alabama • Homewood, Alabama • Phoenix, Arizona + 75 more

Conditions: Nonalcoholic Fatty Liver Disease
Interventions: Saroglitazar Magnesium 4 mg, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 4 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2023
U.S. locations: 8
States / cities: Birmingham, Alabama • La Jolla, California • San Francisco, California + 5 more

Conditions: Primary Biliary Cholangitis
Interventions: Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 196 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2025
U.S. locations: 31
States / cities: Birmingham, Alabama • Tucson, Arizona • Los Angeles, California + 27 more

Conditions: Renal Impairment
Interventions: Saroglitazar magnesium; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 80 Years
Enrollment: 32 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2024
U.S. locations: 2
States / cities: DeLand, Florida • San Antonio, Texas

Conditions: Non Alcoholic Steatohepatitis
Interventions: Saroglitazar Magnesium 2mg, Saroglitazar Magnesium 4mg, Placebos; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 16 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2020
U.S. locations: 6
States / cities: Jackson, Mississippi • Germantown, Tennessee • Hermitage, Tennessee + 2 more

Conditions: Cholestatic Liver Disease
Interventions: Saroglitazar Magnesium 1 mg; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 80 Years
Enrollment: 6 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2026
U.S. locations: 1
States / cities: Indianapolis, Indiana

Conditions: Primary Biliary Cholangitis
Interventions: Saroglitazar Magnesium 1 mg, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 80 Years
Enrollment: 90 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2028
U.S. locations: 1
States / cities: Lakewood Rch, Florida

Conditions: Hepatic Impairment
Interventions: Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 80 Years
Enrollment: 98 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2022
U.S. locations: 2
States / cities: Indianapolis, Indiana • San Antonio, Texas

Conditions: Healthy
Interventions: Saroglitazar magnesium; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 55 Years · Male only
Enrollment: 8 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2019
U.S. locations: 1
States / cities: Madison, Wisconsin

Conditions: Dyslipidemias
Interventions: Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 124 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2024
U.S. locations: 33
States / cities: Huntsville, Alabama • Encinitas, California • San Diego, California + 29 more

Conditions: Non-alcoholic Fatty Liver Disease in Women With PCOS
Interventions: Saroglitazar Magnesium 4 mg Tablet, Placebo; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 45 Years · Female only
Enrollment: 60 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2024
U.S. locations: 13
States / cities: Chandler, Arizona • Panorama City, California • San Francisco, California + 9 more

Conditions: Liver Transplant; Complications, NAFLD
Interventions: Saroglitazar; Drug
Lead sponsor: Zydus Therapeutics Inc.; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 20 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2021
U.S. locations: 1
States / cities: Richmond, Virginia

Search by objective public record fields.

Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

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

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects

Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL

Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)

Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)