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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Saroglitazar Clear all
Terminated Phase 2 Interventional Results available

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

NCT03617263
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Dec 17, 2025 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 2 Interventional Results available

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

NCT03061721
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 23, 2024 · Synced Sep 11, 2026, 1:33 PM EDT
Suspended Phase 2 Interventional

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

NCT03097107
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Feb 7, 2023 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 2 Interventional Results available

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

NCT03112681
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 1 Interventional

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

NCT04446507
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 19, 2024 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 2Phase 3 Interventional

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

NCT05133336
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 11, 2026, 1:33 PM EDT
Recruiting Phase 1 Interventional

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

NCT06825559
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 2 Interventional Results available

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

NCT03863574
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 14, 2024 · Synced Sep 11, 2026, 1:33 PM EDT
Terminated Phase 2 Interventional Results available

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

NCT05211284
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 1, 2025 · Synced Sep 11, 2026, 1:33 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

NCT05045482
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT04112446
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Nov 12, 2019 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 2 Interventional

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

NCT05011305
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 23, 2025 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 2 Interventional Results available

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

NCT03639623
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 23, 2024 · Synced Sep 11, 2026, 1:33 PM EDT
Completed Phase 1 Interventional

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

NCT04469920
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Sep 19, 2024 · Synced Sep 11, 2026, 1:33 PM EDT
Recruiting Phase 3 Interventional

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

NCT07216235
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Aug 3, 2026 · Synced Sep 11, 2026, 1:33 PM EDT
Active, not recruiting Phase 3 Interventional

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

NCT06427395
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated May 11, 2026 · Synced Sep 11, 2026, 1:33 PM EDT