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NOT YET RECRUITING
NCT07424677
PHASE3

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

Sponsor: Zydus Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

89

Start Date

2026-03

Completion Date

2028-11

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

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