Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

April 30, 2025

Study Completion Date

May 7, 2025

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Saroglitazar Magnesium 1 mg

Subjects randomized to Saroglitazar Magnesium 1 mg arm will receive Saroglitazar Magnesium 1 mg treatment for the entire treatment period up to Week 52.

DRUG

Saroglitazar Magnesium 2 mg

Subjects randomized to Saroglitazar Magnesium 2 mg arm are switched to Saroglitazar Magnesium 1 mg treatment up to Week 52

DRUG

Placebo

Subjects randomized to placebo arm will receive placebo treatment for the entire treatment period up to Week 52.

Trial Locations (57)

11030

Zydus US038, Manhasset

14642

Zydus US035, Rochester

16059

Zydus TR005, Bursa

19141

Zydus US015, Philadelphia

22908

Zydus US016, Charlottesville

23219

Zydus US039, Richmond

23602

Zydus US041, Newport News

27080

Zydus TR008, Gaziantep

28204

Zydus US002, Charlotte

30060

Zydus US020, Marietta

32224

Zydus US027, Jacksonville

33110

Zydus TR006, Mersin

33136

Zydus US005, Miami

33606

Zydus US019, Tampa

34093

Zydus TR009, Istanbul

34098

Zydus TR010, Istanbul

34211

Zydus US006, Lakewood Rch

34240

Zydus US028, Sarasota

34764

Zydus TR003, Istanbul

34899

Zydus TR001, Istanbul

35100

Zydus TR002, Izmir

35150

Zydus TR013, Izmir

35294

Zydus US007, Birmingham

38030

Zydus TR015, Melikgazi

41380

Zydus TR011, Kocaeli

45044

Zydus US014, Cincinnati

46202

Zydus US001, Indianapolis

52242

Zydus US034, Iowa City

55905

Zydus US023, Rochester

63104

Zydus US030, St Louis

68105

Zydus US024, Omaha

70072

Zydus US036, Marrero

77030

Zydus US004, Houston

Zydus US042, Houston

80045

Zydus US022, Aurora

84107

Zydus US031, Murray

85724

Zydus US021, Tucson

90048

Zydus US013, Los Angeles

91105

Zydus US011, Pasadena

95817

Zydus US043, Sacramento

98105

Zydus US033, Seattle

06510

Zydus US037, New Haven

B1629ODT

Zydus AR004, Buenos Aires

B7600FZO

Zydus AR009, Buenos Aires

C1118AAT

Zydus AR001, Buenos Aires

C1125ABE

Zydus AR005, Buenos Aires

C1180AAX

Zydus AR013, Buenos Aires

C1199ABB

Zydus AR007, Buenos Aires

C1221ADC

Zydus AR006, Buenos Aires

C1426ABP

Zydus AR012, Buenos Aires

C1430CKE

Zydus AR003, Buenos Aires

S2002KDS

Zydus AR010, Santa Fe

IS-101

Zydus IS001, Reykjavik

01790

Zydus TR014, Adana

06230

Zydus TR016, Altındağ

06800

Zydus TR004, Ankara

06620

Zydus TR017, Cebeli

All Listed Sponsors
lead

Zydus Therapeutics Inc.

INDUSTRY