Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
Public ClinicalTrials.gov record NCT03061721. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Prospective, Multicenter, Double-blind, Randomized Study of Saroglitazar Magnesium 1 mg, 2 mg or 4 mg Versus Placebo in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03061721
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 106 participants
Conditions and interventions
Interventions
- Saroglitazar magnesium 1 mg Drug
- Saroglitazar magnesium 2 mg Drug
- Saroglitazar magnesium 4 mg Drug
- Placebos Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 5, 2017
- Primary completion
- Aug 21, 2019
- Completion
- Aug 21, 2019
- Last update posted
- Oct 23, 2024
2017 – 2019
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Precision Research | Chula Vista | California | 91910 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Catalina Research Institute | Montclair | California | 91763 | — |
| California liver research institute | Pasadena | California | 91105 | — |
| Precision Research | San Diego | California | 92114 | — |
| University of Florida | Gainesville | Florida | 32601 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Avail Clinical Research | Orange City | Florida | 32763 | — |
| Indiana University | Indianapolis | Indiana | 46290 | — |
| Mercy Medical Center | Baltimore | Maryland | 21201 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5362 | — |
| Awasty Research Network, LLC | Marion | Ohio | 43302 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| AIG Research | Hermitage | Tennessee | 37076 | — |
| Liver Consultants | Dallas | Texas | 75246 | — |
| The Liver Institute | San Antonio | Texas | 78215 | — |
| Swedish Medical Center | Seattle | Washington | 89104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03061721, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2024 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03061721 live on ClinicalTrials.gov.