Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy

NCT07424677 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SARO.24.001
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy

Conditions

Primary Biliary Cholangitis

Keywords

Primary Biliary Cholangitis; Saroglitazar Magnesium; PBC

Outcome Measures

Primary Outcomes (1)

• The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP

  Baseline to Week 52

Secondary Outcomes (3)

• The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP

  Baseline to Week 4

• Change from baseline in the Global PBC Study Group (GLOBE) scores

  Baseline to Week 52

• Change from baseline in the United Kingdom Primary Biliary Cholangitis (UK-PBC)

  Baseline to Week 52

Study Arms (2)

Saroglitazar Magnesium 1 mg

EXPERIMENTAL

Saroglitazar magnesium 1 mg, once daily, orally each morning before breakfast

Drug: Saroglitazar Magnesium 1 mg

Placebo

PLACEBO COMPARATOR

Matching Placebo once daily, orally each morning before breakfast

Drug: Placebo

Interventions

Saroglitazar Magnesium 1 mg DRUG

Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast

Saroglitazar Magnesium 1 mg

Placebo DRUG

Matching Placebo once daily, orally each morning before breakfast

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 18 and 80 years of age (both inclusive at screening)
• History of confirmed Primary Biliary Cholangitis diagnosis
• Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit).
• Average Alkaline Phosphatase at both screening Visits 1 and 2: \> 1× Upper Limit of Normal and \< 1.67× Upper Limit of Normal, and \< 30% variance between both levels
• Total bilirubin ≤ 2 x Upper Limit of Normal at screening (Visit 1), unless there is a prior diagnosis of Gilbert's syndrome. For participants with Gilbert's syndrome, direct bilirubin is to be ≤ 2 x Upper Limit of Normal at screening (Visit 1).
• Must have given written informed consent (signed and dated).

You may not qualify if:

• Consumption of 14 or more standard alcohol drinks per week if male and 7 or more standard alcohol drink per week if female for at least 3 consecutive months (i.e., 12 consecutive weeks) within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
• History or presence of other concomitant liver diseases at screening
• Cirrhosis with complications, including history or presence of the following: spontaneous bacterial peritonitis, hepatocellular carcinoma, ascites requiring treatment, encephalopathy, known large esophageal varices, or history of variceal bleeding within one year prior to screening or history of hepatorenal syndrome.
• Medical conditions that may cause non-hepatic increases in Alkaline Phosphatase (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years, including known cancers.
• Use of obeticholic acid, thiazolidinediones, fibrates (i.e. fenofibrate, bezafibrate, pemafibrate), other Peroxisome Proliferator-Activated Receptor agonists (i.e., seladelpar, elafibranor, lanifibranor), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids (equivalent to prednisone dose more than 10 mg per day); 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 or listed for orthotopic liver transplant.
• Type 1 diabetes mellitus.
• Unstable cardiovascular disease
• History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, coagulation disorders, or screening blood tests that, in the opinion of the Investigator, indicate clinically significant altered coagulability (e.g., Prothrombin Time, International Normalized Ratio, Activated partial thromboplastin time) at screening.
• An uncontrolled thyroid disorder
• History of myopathies or evidence of active muscle disease demonstrated by Creatine Phosphokinase ≥ 5 x Upper Limit of Normal at screening.
• For subjects with elevated baseline Alanine Aminotransferase or Aspartate Aminotransferase; Alanine Aminotransferase or Aspartate Aminotransferase exceeding by more than 50% on Visit 2 compared to Visit 1.
• Any of the following laboratory values at screening:
• Platelets \< 100 × 10\^9/L
• Albumin \< 3.5 g/dL

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

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

Central Study Contacts

Farheen Shaikh

CONTACT

609-730-1900; fshaikh@zydustherapeutics.com

Deven Parmar

CONTACT

609-703-1900; dparmar@zydustherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 efficacy and safety study

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02