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Completed Phase 2Phase 3 Interventional

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

ClinicalTrials.gov ID: NCT05133336

Public ClinicalTrials.gov record NCT05133336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05133336
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Zydus Therapeutics Inc.
Industry
Enrollment
196 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 1, 2022 (Actual)
Primary completion
Apr 30, 2025 (Actual)
Completion
May 7, 2025 (Actual)
Last update posted
Sep 17, 2026

2022 – 2025

United States locations

U.S. sites
31
U.S. states
21
U.S. cities
30
Facility City State ZIP Site status
Zydus US007 Birmingham Alabama 35233 —
Zydus US021 Tucson Arizona 85724 —
Zydus US013 Los Angeles California 90048 —
Zydus US011 Pasadena California 91105 —
Zydus US043 Sacramento California 95817 —
Zydus US022 Aurora Colorado 80045 —
Zydus US037 New Haven Connecticut 06510 —
Zydus US027 Jacksonville Florida 32224 —
Zydus US006 Lakewood Rch Florida 34211 —
Zydus US005 Miami Florida 33136 —
Zydus US028 Sarasota Florida 34201 —
Zydus US019 Tampa Florida 33606 —
Zydus US020 Marietta Georgia 30060 —
Zydus US001 Indianapolis Indiana 46202 —
Zydus US034 Iowa City Iowa 52242 —
Zydus US036 Marrero Louisiana 70072 —
Zydus US023 Rochester Minnesota 55905 —
Zydus US030 St Louis Missouri 63104 —
Zydus US024 Omaha Nebraska 68198 —
Zydus US038 Manhasset New York 11030 —
Zydus US035 Rochester New York 14642 —
Zydus US002 Charlotte North Carolina 28204 —
Zydus US014 Cincinnati Ohio 45044 —
Zydus US015 Philadelphia Pennsylvania 19141 —
Zydus US004 Houston Texas 77030 —
Zydus US042 Houston Texas 77030 —
Zydus US031 Murray Utah 84107 —
Zydus US016 Charlottesville Virginia 22908 —
Zydus US041 Newport News Virginia 23602 —
Zydus US039 Richmond Virginia 23298 —
Zydus US033 Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05133336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05133336 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →