NCT02316717

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

A Phase ll, Randomized, Double-blind, Placebo-controlled Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Immuron Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate. Eligible subjects will be randomized at the Baseline visit to receive one of the three study treatments three times daily for a period of 24 weeks. Each subject will return to the study clinic for assessment and required study procedures on Day 7, 14 and 28 and every 4 weeks thereafter until Week 24.

Conditions

• Non-alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
BIOLOGICAL	IMM-124E	IMM-124E
OTHER	Placebo	Matched placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-10-30
• Completion: 2017-10-30
• First posted: 2014-12-15
• Last updated: 2020-02-21
• Results posted: 2020-02-21

Locations

25 sites across 3 countries: United States, Australia, Israel