Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

NCT03061721 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 106 participants
Start Date 2017-04-06
Est. Completion 2019-08-22
Phase Phase 2

Sponsor

Zydus Therapeutics

36 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zydus Therapeutics, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03061721 reports 18 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03061721?

This trial is sponsored by Zydus Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial