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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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 2 |
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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.
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