MedTrace Logo

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

NCT05133336 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-04-30

No results posted yet for this study

Summary

Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)

Conditions

Interventions

DRUG

Saroglitazar Magnesium 1 mg

Subjects randomized to Saroglitazar Magnesium 1 mg arm will receive Saroglitazar Magnesium 1 mg treatment for the entire treatment period up to Week 52.

DRUG

Saroglitazar Magnesium 2 mg

Subjects randomized to Saroglitazar Magnesium 2 mg arm are switched to Saroglitazar Magnesium 1 mg treatment up to Week 52

DRUG

Placebo

Subjects randomized to placebo arm will receive placebo treatment for the entire treatment period up to Week 52.

Sponsors & Collaborators

  • Zydus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Deven V Parmar, MD · Zydus Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-04-30
Completion
2025-05-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Iceland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT05133336 on ClinicalTrials.gov