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

NCT07424677 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-07-31
Completion
2028-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424677 on ClinicalTrials.gov