ClinicalTrials.gov record
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 May 19, 2026, 11:23 AM 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

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

Interventions

  • Placebo Drug
  • Saroglitazar Magnesium 1 mg Drug
  • Saroglitazar Magnesium 2 mg Drug

Drug

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
Mar 31, 2022
Primary completion
Apr 29, 2025
Completion
May 6, 2025
Last update posted
Apr 29, 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 35294
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 34240
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 68105
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 23219
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 Apr 29, 2026 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05133336 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →