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

COMPLETED Phase 2

A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis

NCT02316717 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.

Interventions

  • OTHER Placebo
  • BIOLOGICAL IMM-124E

Study Locations (20)

Virginia

  • University of Virginia Medical Centre — Charlottesville
  • Mary Immaculate Hospital — Newport News
  • Bon Secours St Marys Hospital — Richmond
  • Virginia Commonwealth University — Richmond

California

  • eStudySite — Chula Vista
  • University of California San Diego — San Diego
  • Quest Clinical Research — San Francisco

Texas

  • Baylor St Lukes Medical Centre — Houston
  • Brooke Army Medical Centre — Houston
  • Pinnacle Clinical Research — Live Oak

New South Wales

  • The Nepean Hospital — Penrith
  • Westmead Hospital — Westmead

Colorado

  • University of Colorado — Aurora

Florida

  • University of Florida Hepatology Research at CTRB — Gainesville

Illinois

  • Northwestern Memorial Hospital — Chicago

Missouri

  • Kansas City Research Institute — Kansas City

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2014-12
Est. Completion 2017-10-30
Phase Phase 2

Sponsor

Immuron

2 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 NCT02316717

The ClinicalTrials.gov registry entry for NCT02316717 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 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immuron, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT02316717 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Virginia, California, Texas. 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 NCT02316717 about?

NCT02316717 is a clinical study titled "A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis". This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.

What is the current status of trial NCT02316717?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2014-12. Estimated completion is 2017-10-30.

What conditions does trial NCT02316717 study?

This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02316717?

The interventions under investigation include: Placebo (OTHER), IMM-124E (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02316717?

This trial is sponsored by Immuron, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02316717 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Missouri. 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