Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Public ClinicalTrials.gov record NCT06427395. 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.
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, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC)
Study identification
- NCT ID
- NCT06427395
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Zydus Therapeutics Inc.
- Industry
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Interventions
- Saroglitazar Magnesium 1 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jul 15, 2024
- Primary completion
- Apr 17, 2027
- Completion
- Jul 17, 2027
- Last update posted
- May 11, 2026
2024 – 2027
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | 06520 | — |
| Zydus US027 | Jacksonville | Florida | 32224 | — |
| Zydus US006 | Lakewood Rch | Florida | 34211 | — |
| Zydus US005 | Miami | Florida | 33136 | — |
| Zydus US020 | Marietta | Georgia | 30060 | — |
| Zydus US001 | Indianapolis | Indiana | 46202 | — |
| Zydus US035 | Rochester | New York | 14642 | — |
| Zydus US002 | Charlotte | North Carolina | 28204 | — |
| Zydus US042 | Houston | Texas | 77030 | — |
| Zydus US031 | Murray | Utah | 84107 | — |
| Zydus US016 | Charlottesville | Virginia | 22908 | — |
| 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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06427395, 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 May 11, 2026 · Synced May 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06427395 live on ClinicalTrials.gov.