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NCT02316717 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Immuron.

Completed
Registry status
Phase 2
Development phase
133
Enrollment target
20
Study locations

NCT02316717 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by Immuron. The registered enrollment target is 133 participants, below the 155-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT02316717, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Immuron.

COMPLETED
Registry status
Phase 2
Development phase
133 participants
Enrollment target
20
Study locations

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

What the Registry Record Tells You About NCT02316717

The ClinicalTrials.gov registry entry for NCT02316717 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (14% lower). The listed sponsor is Immuron, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT02316717 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Virginia, California, Texas.

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).

What interventions are being tested in trial NCT02316717?

The interventions under investigation include: Placebo (OTHER), IMM-124E (BIOLOGICAL).

Who is sponsoring clinical trial NCT02316717?

This trial is sponsored by Immuron, which has 2 total clinical trials registered on ClinicalTrials.gov.

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

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.