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

NCT06427395 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-12

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Saroglitazar Magnesium 1 mg

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

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven Parmar · Zydus Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2027-04-18
Completion
2027-07-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT06427395 on ClinicalTrials.gov