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

NCT06427395 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SARO.23.002
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 28

Brief Summary

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

Conditions

Primary Biliary Cholangitis

Keywords

Saroglitazar Magnesium; Primary Biliary Cholangitis; PBC

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From baseline to 24 Months/EOT

Secondary Outcomes (21)

• Proportion of participants achieving biochemical response based on the composite endpoints of ALP and total bilirubin

  From baseline to Months 12 and 24/EOT

• Proportion of participants with biochemical response based on the composite endpoints of ALP and total bilirubin

  From baseline to Months 12 and 24/EOT

• Time to occurrence of the clinical outcome events in study participants with PBC

  From baseline to 24 Months/EOT

• Time to occurrence of the clinical outcome events based on Model for End Stage Liver Disease 3.0 score

  From baseline to 24 Months/EOT

• Time to first occurrence of Liver transplant or placement on a liver transplant list

  From baseline to 24 Months/EOT

Study Arms (1)

Saroglitazar Magnesium 1 mg

EXPERIMENTAL

Saroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).

Drug: Saroglitazar Magnesium 1 mg

Interventions

Saroglitazar Magnesium 1 mg DRUG

Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program

Saroglitazar Magnesium 1 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must provide written informed consent and agree to comply with the trial protocol
• Participated and completed SARO.21.001, the double-blind treatment phase study

You may not qualify if:

• Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening.
• Participants with MELD 3.0 score of 15 or greater
• History or presence of other concomitant liver diseases at screening:
• Chronic hepatitis B or C virus (HBV, HCV) infection
• Primary sclerosing cholangitis (PSC)
• Alcoholic liver disease
• Autoimmune hepatitis (AIH)-PBC overlap syndrome
• Hemochromatosis
• Non-alcoholic steatohepatitis (NASH) on historical biopsy
• Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening.
• Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
• Use of other PPAR agonists (i.e., Elafibranor, Seladelpar), Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening)
• History of bowel surgery (gastrointestinal \[bariatric\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT
• Unstable cardiovascular disease, including:
• Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (28)

Zydus US013

Los Angeles, California, 90048, United States

RECRUITING

Zydus US011

Pasadena, California, 91105, United States

RECRUITING

Zydus US043

Sacramento, California, 95817, United States

RECRUITING

Zydus US022

Aurora, Colorado, 80045, United States

RECRUITING

Zydus US037

New Haven, Connecticut, 06520, United States

RECRUITING

Zydus US027

Jacksonville, Florida, 32224, United States

RECRUITING

Zydus US006

Lakewood Rch, Florida, 34211, United States

COMPLETED

Zydus US005

Miami, Florida, 33136, United States

RECRUITING

Zydus US020

Marietta, Georgia, 30060, United States

RECRUITING

Zydus US001

Indianapolis, Indiana, 46202, United States

RECRUITING

Zydus US035

Rochester, New York, 14642, United States

RECRUITING

Zydus US002

Charlotte, North Carolina, 28204, United States

RECRUITING

Zydus US042

Houston, Texas, 77030, United States

RECRUITING

Zydus US031

Murray, Utah, 84107, United States

RECRUITING

Zydus US016

Charlottesville, Virginia, 22908, United States

RECRUITING

Zydus US039

Richmond, Virginia, 23298, United States

RECRUITING

Zydus US033

Seattle, Washington, 98105, United States

RECRUITING

Zydus AR001

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

RECRUITING

Zydus AR007

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

RECRUITING

Zydus AR006

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1221ADC, Argentina

RECRUITING

Zydus AR005

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425BGC, Argentina

RECRUITING

Zydus AR003

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1430CKE, Argentina

RECRUITING

Zydus AR004

Pilar, Buenos Aires, B1629ODT, Argentina

RECRUITING

Zydus TR016

Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Zydus TR004

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Zydus TR005

Bursa, 16059, Turkey (Türkiye)

RECRUITING

Zydus TR017

Cebeli, 06620, Turkey (Türkiye)

RECRUITING

Zydus TR015

Melikgazi, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

saroglitazar

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deven Parmar

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Farheen Shaikh

CONTACT

609-730-1900; fshaikh@zydustherapeutics.com

Deven Parmar

CONTACT

609-559-0765; dparmar@zydustherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Open-Label, phase III, safety and efficacy study

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 23, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): July 18, 2027
• Last Updated: February 9, 2026

Record last verified: 2025-05

Locations

AR (6); TU (5); US (17)