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NCT06427395 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
A Phase 3 study of Primary Biliary Cholangitis, sponsored by Zydus Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06427395: Recruiting Phase 3 study of Primary Biliary Cholangitis, sponsored by Zydus Therapeutics.
NCT06427395 is a Phase 3 study of Primary Biliary Cholangitis that is actively recruiting participants, run by Zydus Therapeutics. The registered enrollment target is 150 participants, below the 188-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06427395, a Phase 3 study of Primary Biliary Cholangitis, is actively recruiting participants, sponsored by Zydus Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Conditions Studied
Interventions
- DRUG Saroglitazar Magnesium 1 mg
Study Locations (20)
California
- Zydus US013 - Los Angeles
- Zydus US011 - Pasadena
- Zydus US043 - Sacramento
Florida
- Zydus US027 - Jacksonville
- Zydus US006 - Lakewood Rch
- Zydus US005 - Miami
Buenos Aires
- Zydus AR001 - Ciudad Autónoma de Buenos Aires
- Zydus AR007 - Ciudad Autónoma de Buenos Aires
- Zydus AR006 - Ciudad Autónoma de Buenos Aires
Virginia
- Zydus US016 - Charlottesville
- Zydus US039 - Richmond
Colorado
- Zydus US022 - Aurora
Connecticut
- Zydus US037 - New Haven
Georgia
- Zydus US020 - Marietta
Indiana
- Zydus US001 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-07-16 |
| Est. Completion | 2027-07-18 |
| Phase | Phase 3 |
What NCT06427395 shows while recruiting
NCT06427395 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 188-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 1 intervention - of which Saroglitazar Magnesium 1 mg is the first listed.
NCT06427395 names 20 study sites across 13 states, led by California, Florida, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT06427395 about?
NCT06427395 is a clinical study titled "Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis". Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
What is the current status of trial NCT06427395?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2024-07-16. Estimated completion is 2027-07-18.
What conditions does trial NCT06427395 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis.
What interventions are being tested in trial NCT06427395?
The interventions under investigation include: Saroglitazar Magnesium 1 mg (DRUG).
Who is sponsoring clinical trial NCT06427395?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06427395 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Biliary Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06427395's enrollment target sits among peer trials
150 5th of 8 higher than 4 of 8 other Primary Biliary Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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