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

NCT02316717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2020-02-21

Study results available
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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

  • Non-alcoholic Steatohepatitis (NASH)

Interventions

BIOLOGICAL

IMM-124E

IMM-124E

OTHER

Placebo

Matched placebo

Sponsors & Collaborators

  • Immuron Ltd.

    lead INDUSTRY

Principal Investigators

  • Dan Peres · Immuron Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-10-30
Completion
2017-10-30

Countries

  • United States
  • Australia
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316717 on ClinicalTrials.gov