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

PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

April 6, 2017

Primary Completion Date

August 22, 2019

Study Completion Date

August 22, 2019

Conditions
Non-Alcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis
Interventions
DRUG

Saroglitazar magnesium 1 mg

Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.

DRUG

Saroglitazar magnesium 2 mg

Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.

DRUG

Saroglitazar magnesium 4 mg

Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.

DRUG

Placebos

Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.

Trial Locations (18)

19141

Einstein Medical Center, Philadelphia

21201

Mercy Medical Center, Baltimore

32601

University of Florida, Gainesville

32763

Avail Clinical Research, Orange City

33136

Schiff Center for Liver Diseases/University of Miami, Miami

37076

AIG Research, Hermitage

38138

Gastro One, Germantown

43302

Awasty Research Network, LLC, Marion

46290

Indiana University, Indianapolis

75246

Liver Consultants, Dallas

78215

The Liver Institute, San Antonio

89104

Swedish Medical Center, Seattle

90048

Cedars-Sinai Medical Center, Los Angeles

91105

California liver research institute, Pasadena

91763

Catalina Research Institute, Montclair

91910

Precision Research, Chula Vista

92114

Precision Research, San Diego

48109-5362

University of Michigan, Ann Arbor

All Listed Sponsors
lead

Zydus Therapeutics Inc.

INDUSTRY

NCT03061721 - Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis | Biotech Hunter | Biotech Hunter