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NCT03061721 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
A Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
- 18
- Study locations
NCT03061721: Completed Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Zydus Therapeutics.
NCT03061721 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis that has completed, run by Zydus Therapeutics. The registered enrollment target is 106 participants, below the 175-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (39% lower). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03061721, a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of Non-alcoholic fatty Liver disease (NAFLD) and/or Non-alcoholic steatohepatitis (NASH). The study will be conducted over a period of up to 22 weeks and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is percentage change from baseline in serum Alanine transaminase (ALT) levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group.
Primary Outcome
Percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Saroglitazar magnesium 1 mg
- DRUG Saroglitazar magnesium 2 mg
- DRUG Saroglitazar magnesium 4 mg
Study Locations (18)
California
- Precision Research - Chula Vista
- Cedars-Sinai Medical Center - Los Angeles
- Catalina Research Institute - Montclair
- California liver research institute - Pasadena
- Precision Research - San Diego
Florida
- University of Florida - Gainesville
- Schiff Center for Liver Diseases/University of Miami - Miami
- Avail Clinical Research - Orange City
Tennessee
- Gastro One - Germantown
- AIG Research - Hermitage
Texas
- Liver Consultants - Dallas
- The Liver Institute - San Antonio
Indiana
- Indiana University - Indianapolis
Maryland
- Mercy Medical Center - Baltimore
Michigan
- University of Michigan - Ann Arbor
Ohio
- Awasty Research Network, LLC - Marion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2017-04-06 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 2 |
What the finished NCT03061721 record still lists
NCT03061721 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 175-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (39% lower).
The record links to 2 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebos is the first listed.
NCT03061721 lists 18 locations in 10 states (California, Florida, Tennessee).
Frequently Asked Questions
What is clinical trial NCT03061721 about?
NCT03061721 is a clinical study titled "Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis". This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of Non-alcoholic fatty Liver disease (NAFLD) and/or Non-alcoholic steatohepatitis (NASH). The study will be conducted over a period of up to 22 weeks and will include an optional Prescreening, Screeni...
What is the current status of trial NCT03061721?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2017-04-06. Estimated completion is 2019-08-22.
What conditions does trial NCT03061721 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT03061721?
The interventions under investigation include: Placebos (DRUG), Saroglitazar magnesium 1 mg (DRUG), Saroglitazar magnesium 2 mg (DRUG), Saroglitazar magnesium 4 mg (DRUG).
Who is sponsoring clinical trial NCT03061721?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03061721 being conducted?
This trial has 18 study locations across California, Florida, Indiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03061721's enrollment target sits among peer trials
106 18th of 57 higher than 40 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease 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.
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