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NCT05133336 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
A Phase 2 study, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT05133336: Completed Phase 2 study, sponsored by Zydus Therapeutics.
NCT05133336 is a Phase 2 study that has completed, run by Zydus Therapeutics. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05133336, a Phase 2 study, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
Primary Outcome
ALP \< 1.67 x ULN, ≥ 15% decrease in ALP relative to baseline, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN in subjects with known Gilbert's syndrome
Interventions
- DRUG Placebo
- DRUG Saroglitazar Magnesium 1 mg
- DRUG Saroglitazar Magnesium 2 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2025-05-07 |
| Phase | Phase 2 |
What the finished NCT05133336 record still lists
NCT05133336 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05133336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05133336 about?
NCT05133336 is a clinical study titled "Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis". Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
What is the current status of trial NCT05133336?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2022-04-01. Estimated completion is 2025-05-07.
What interventions are being tested in trial NCT05133336?
The interventions under investigation include: Placebo (DRUG), Saroglitazar Magnesium 1 mg (DRUG), Saroglitazar Magnesium 2 mg (DRUG).
Who is sponsoring clinical trial NCT05133336?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05133336's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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