NCT07424677

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

A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Zydus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy of Saroglitazar Magnesium 1 mg on normalization of ALP in patients having ALP \> ULN to \< 1.67xULN and on Ursodeoxycholic Acid for 12 months or intolerant to Ursodeoxycholic Acid.

Conditions

• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Saroglitazar Magnesium 1 mg	Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast
DRUG	Placebo	Matching Placebo once daily, orally each morning before breakfast

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-07-01
• Completion: 2028-11-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Regulatory

• FDA-regulated drug study