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NCT03617263 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
A Phase 2 study, sponsored by Zydus Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03617263: Clinical Trial Phase 2 study, sponsored by Zydus Therapeutics.
NCT03617263 is a Phase 2 study that was terminated before completion, run by Zydus Therapeutics. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617263, a Phase 2 study, was terminated before completion, sponsored by Zydus Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
Primary Outcome
Change in hepatic fat content from baseline following 24 weeks of treatment as measured by Magnetic Resonance Imaging-derived Proton Density-fat Fraction (MRI-PDFF)
Interventions
- DRUG Placebo
- DRUG Saroglitazar Magnesium 4 mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 2 |
Why NCT03617263 stopped before completion
NCT03617263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03617263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617263 about?
NCT03617263 is a clinical study titled "Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)". This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
What is the current status of trial NCT03617263?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-02-12. Estimated completion is 2024-10-28.
What interventions are being tested in trial NCT03617263?
The interventions under investigation include: Placebo (DRUG), Saroglitazar Magnesium 4 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT03617263?
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 NCT03617263's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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