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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 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 188-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (44% lower). The trial reports 18 study locations across 10 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03061721
The ClinicalTrials.gov registry entry for NCT03061721 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 188-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (44% lower). The listed sponsor is Zydus Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.