Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis with Fibrosis

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

August 18, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Nonalcoholic SteatohepatitisFibrosis
Interventions
DRUG

Saroglitazar Magnesium 2 mg

Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

DRUG

Saroglitazar Magnesium 4 mg

Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

DRUG

Placebo

Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.

Trial Locations (152)

10032

Zydus US055, New York

10033

Zydus US066, New York

10310

Zydus US056, Staten Island

11030

Zydus US069, Manhasset

12208

Zydus US083, Albany

14642

Zydus US068, Rochester

16059

Zydus TR004, Bursa

17033

Zydus US060, Hershey

19141

Zydus US053, Philadelphia

20110

Zydus US070, Manassas

20889

Zydus US042, Bethesda

23236

Zydus US082, Richmond

23298

Zydus US021, Richmond

27310

Zydus TR005, Gaziantep

28204

Zydus US027, Charlotte

28801

Zydus US018, Asheville

29204

Zydus US073, Columbia

29401

Zydus US015, Charleston

29425

Zydus US030, Charleston

29485

Zydus US112, Summerville

29646

Zydus US075, Greenwood

30060

Zydus US114, Marietta

30501

Zydus US113, Gainesville

30720

Zydus US107, Dalton

31406

Zydus US119, Savannah

32127

Zydus US104, Port Orange

32751

Zydus US001, Maitland

Zydus US124, Maitland

32789

Zydus US004, Winter Park

32806

Zydus US085, Orlando

33009

Zydus US108, Hallandale

33014

Zydus US007, Miami

33016

Zydus US096, Hialeah Gardens

Zydus US098, Miami Lakes

33110

Zydus TR012, Mersin

33135

Zydus US024, Miami

33136

Zydus US034, Miami

Zydus US038, Miami

33155

Zydus US121, Miami

33173

Zydus US054, Miami

33180

Zydus US006, Aventura

33761

Zydus US122, Clearwater

33777

Zydus US125, Largo

33803

Zydus US003, Lakeland

33907

Zydus US057, Fort Myers

34093

Zydus TR009, Istanbul

34102

Zydus US099, Naples

34211

Zydus US016, Lakewood Rch

34471

Zydus US081, Ocala

34760

Zydus TR008, Istanbul

35100

Zydus TR007, Izmir

35150

Zydus TR006, Izmir

35209

Zydus US079, Homewood

35294

Zydus US032, Birmingham

37067

Zydus US011, Hermitage

37232

Zydus US028, Nashville

38039

Zydus TR011, Kayseri

41000

Zydus TR010, Kocaeli

43213

Zydus US091, Columbus

44109

Zydus US035, Cleveland

44145

Zydus US093, Westlake

45044

Zydus US010, Cincinnati

45066

Zydus US072, Springboro

46202

Zydus US020, Indianapolis

48047

Zydus US092, Chesterfield

49519

Zydus US019, Wyoming

50652

Zydus US100, West Des Moines

53020

Zydus TR013, Rize

55101

Zydus US115, Saint Paul

61080

Zydus TR014, Trabzon

63110

Zydus US063, St Louis

Zydus US084, St Louis

64131

Zydus US120, Kansas City

65201

Zydus US074, Columbia

66160

Zydus US049, Kansas City

70072

Zydus US014, Marrero

70121

Zydus US045, New Orleans

70363

Zydus US071, Houma

71291

Zydus US123, West Monroe

72205

Zydus US046, Little Rock

75203

Zydus US048, Dallas

76012

Zydus US002, Arlington

76104

Zydus US061, Fort Worth

76301

Zydus US076, Wichita Falls

76710

Zydus US058, Waco

76712

Zydus US078, Waco

77030

Zydus US067, Houston

Zydus US109, Houston

77058

Zydus US005, Houston

77079

Zydus US110, Houston

77084

Zydus US117, Katy

77401

Zydus US089, Bellaire

78215

Zydus US031, San Antonio

78222

Zydus US103, San Antonio

78229

Zydus US036, San Antonio

Zydus US102, San Antonio

78234

Zydus US043, San Antonio

78240

Zydus US008, San Antonio

78520

Zydus US105, Brownsville

78539

Zydus US095, Edinburg

Zydus US106, Edinburg

78745

Zydus US051, Austin

78757

Zydus US064, Austin

Zydus US101, Austin

80045

Zydus US039, Aurora

84405

Zydus US088, Ogden

85013

Zydus US047, Phoenix

85054

Zydus US050, Phoenix

85224

Zydus US026, Chandler

85712

Zydus US025, Tucson

Zydus US087, Tucson

85724

Zydus US029, Tucson

89511

Zydus US116, Reno

90027

Zydus US022, Los Angeles

90033

Zydus US062, Los Angeles

90048

Zydus US040, Los Angeles

90247

Zydus US111, Gardena

90255

Zydus US013, Huntington Park

90808

Zydus US080, Long Beach

90815

Zydus US090, Long Beach

91402

Zydus US012, Panorama City

91730

Zydus US059, Rancho Cucamonga

91911

Zydus US118, Chula Vista

92037

Zydus US065, La Jolla

92563

Zydus US023, Murrieta

92868

Zydus US052, Orange

93534

Zydus US094, Lancaster

93720

Zydus US041, Fresno

94063

Zydus US037, Redwood City

98101

Zydus US044, Seattle

98104

Zydus US033, Seattle

02215

Zydus US017, Boston

01805

Zydus US086, Burlington

07871

Zydus US077, Sparta

45267-0595

Zydus US009, Cincinnati

B1629ODT

Zydus AR004, Buenos Aires

C1056ABJ

Zydus AR001, CABA

C1180AAX

Zydus AR013, CABA

C1199ABB

Zydus AR007, CABA

C1221ADC

Zydus AR006, CABA

C1264AAA

Zydus AR005, CABA

C1425AGC

Zydus AR008, CABA

C1426ABP

Zydus AR012, CABA

CP143CKE

Zydus AR003, CABA

B7600

Zydus AR009, Mar del Plata

Unknown

Zydus AR011, Mar del Plata

Zydus AR002, Ramos Mejía

S2002KDS

Zydus AR010, Rosario

00927

Zydus US097, San Juan

01240

Zydus TR003, Adana

06230

Zydus TR002, Ankara

06800

Zydus TR001, Ankara

All Listed Sponsors
lead

Zydus Therapeutics Inc.

INDUSTRY