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NCT05011305 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
A Phase 2 study, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
NCT05011305: Completed Phase 2 study, sponsored by Zydus Therapeutics.
NCT05011305 is a Phase 2 study that has completed, run by Zydus Therapeutics. The registered enrollment target is 189 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011305, a Phase 2 study, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
Study Summary
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
Primary Outcome
Resolution of steatohepatitis is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0-1 for inflammation, 0 for ballooning, and any value for Steatosis
Interventions
- DRUG Placebo
- DRUG Saroglitazar Magnesium 2 mg
- DRUG Saroglitazar Magnesium 4 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2025-09-12 |
| Phase | Phase 2 |
What the finished NCT05011305 record still lists
NCT05011305 is an interventional study that assigns participants to a tested intervention. The registered 189 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 (42% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05011305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05011305 about?
NCT05011305 is a clinical study titled "Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis". Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
What is the current status of trial NCT05011305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2021-08-18. Estimated completion is 2025-09-12.
What interventions are being tested in trial NCT05011305?
The interventions under investigation include: Placebo (DRUG), Saroglitazar Magnesium 2 mg (DRUG), Saroglitazar Magnesium 4 mg (DRUG).
Who is sponsoring clinical trial NCT05011305?
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 NCT05011305's enrollment target sits among peer trials
189 355th of 2000 higher than 1,645 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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