CLINICAL TRIALS PROFILE FOR SAROGLITAZAR

Clinical Trials for Saroglitazar

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02265276 ↗	A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease	Unknown status	Command Hospital, India	Phase 3	Non Alcoholic Fatty Liver Disease (NAFLD) is considered as the component of metabolic syndrome. The prevalence of the same has been increasing rapidly in India, along with an increase in the prevalence of diabetes and obesity. Insulin resistance is the key underlying pathogenetic mechanism of NAFLD. NAFLD accounts for significant morbidity and mortality and the therapeutic options are limited. Insulin sensitizing drugs are used in the management of NAFLD.
NCT03061721 ↗	Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis	Completed	Zydus Discovery DMCC	Phase 2	This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group.
NCT03061721 ↗	Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis	Completed	Zydus Therapeutics Inc.	Phase 2	This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group.
NCT03097107 ↗	Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL	Suspended	Zydus Discovery DMCC	Phase 2	To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.
NCT03097107 ↗	Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL	Suspended	Zydus Therapeutics Inc.	Phase 2	To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.
NCT03112681 ↗	Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis	Completed	Zydus Discovery DMCC	Phase 2	prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.
NCT03112681 ↗	Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis	Completed	Zydus Therapeutics Inc.	Phase 2	prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.

Clinical Trial Conditions for Saroglitazar

Condition Name

Condition Name
Intervention	Trials
NAFLD	3
Nonalcoholic Steatohepatitis	3
Healthy	2
Hepatic Impairment	2

Condition MeSH

Condition MeSH
Intervention	Trials
Non-alcoholic Fatty Liver Disease	9
Fatty Liver	8
Liver Diseases	7
Liver Cirrhosis, Biliary	2

Clinical Trial Locations for Saroglitazar

Trials by Country

Trials by Country
Location	Trials
United States	55
Mexico	5
India	3

Trials by US State

Trials by US State
Location	Trials
Texas	6
Indiana	5
Florida	5
California	5
Tennessee	4

Clinical Trial Progress for Saroglitazar

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	7
Completed	5
Not yet recruiting	3

Clinical Trial Sponsors for Saroglitazar

Sponsor Name

Sponsor Name
Sponsor	Trials
Zydus Therapeutics Inc.	14
Zydus Discovery DMCC	10
Asian Institute of Gastroenterology, India	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	25
Other	2