Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

133

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2014

Typical duration for phase_2

Geographic Reach

3 countries

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

November 6, 2014

Completed

25 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed

14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

February 21, 2020

Completed

Last Updated

February 21, 2020

Status Verified

January 1, 2020

Enrollment Period

2.9 years

First QC Date

November 6, 2014

Results QC Date

January 7, 2020

Last Update Submit

February 8, 2020

Conditions

Non-alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (4)

Safety Outcome Measure
Incidence of adverse events per arm/group
24 Weeks
Percentage Fat Content of the Liver
Mean change from Baseline in Percentage Fat Content of the Liver measured by Magnetic Resonance Imaging (MRI) at Week 24
baseline and 24 weeks
Adverse Events
Number of patients with treatment-related adverse events
24 weeks
Severity of Adverse Events
Number of grade 3-5 adverse events
24 weeks

Secondary Outcomes (24)

Systolic Blood Pressure
baseline and 24 weeks
Pulse Rate
baseline and 24 weeks
Diastolic Blood Pressure
baseline and 24 weeks
Respiratory Rate
baseline and 24 weeks
Serum Alanine Aminotransaminase (ALT)
baseline and 24 weeks
+19 more secondary outcomes

Other Outcomes (13)

Serum Concentrations of Lipopolysaccharide (LPS)
0, 4, 12 and 24 Weeks
Regulatory T Cells (FoxP3+ CD25-CD4+) in Peripheral Blood Mononuclear Cells
0 and 24 Weeks
Gut Microbiome From Fecal Samples
0, 4, 12 and 24 Weeks
+10 more other outcomes

Study Arms (3)

Treatment Arm A

EXPERIMENTAL

IMM-124E, 600 mg three times daily, orally plus matching placebo

Biological: IMM-124E

Treatment Arm B

EXPERIMENTAL

IMM-124E, 1200 mg three times daily, orally

Biological: IMM-124E

Treatment Arm C

PLACEBO COMPARATOR

Matching placebo, three times daily, orally

Other: Placebo

Interventions

IMM-124EBIOLOGICAL

IMM-124E

Treatment Arm ATreatment Arm B

PlaceboOTHER

Matched placebo

Treatment Arm C

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years.
Provision of written informed consent.
Diagnosis of NASH, histologically proven within 12 months of Screening with
NASH activity score (NAS) of 4 or more
cytologic ballooning score of at least 1;
% or more macrovescicular steatosis.
Hematoxylin \& Eosin (H\&E) stained slides and/or paraffin block available for independent assessment.
HBA1C of \<9.0
Agree to the use of effective contraceptive measures if either male or female of child bearing potential.

You may not qualify if:

Presence of vascular liver disease or cirrhosis;
Presence of liver disease with other cause (autoimmune, metabolic, medication induced);
BMI \<25 kg/m\^2;
Alcohol use \>30 g/day;
Type 1 diabetes;
\. History of major bariatric surgery (not including balloon / sleeve gastrectomy);
Weight loss or gain of 5kg or more in the past 6 months or \>10% change in bodyweight in the past 12 months;
Contraindication for MRI;
Inadequate venous access;
Lactating/breastfeeding/pregnant at Screening or Baseline;
HIV antibody positive, hepatitis B surface antigen positive (HBsAg) or Hepatitis C virus (HCV)-RNA positive;
Receiving an elemental diet or parenteral nutrition;
Concurrent conditions
Inflammatory bowel disease;
Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of Screening;
+27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Immuron Ltd.lead

Study Sites (25)

eStudySite

Chula Vista, California, 91911, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida Hepatology Research at CTRB

Gainesville, Florida, 32610, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Duke Liver Centre

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Baylor St Lukes Medical Centre

Houston, Texas, 77030, United States

Location

Brooke Army Medical Centre

Houston, Texas, 78234, United States

Location

Pinnacle Clinical Research

Live Oak, Texas, 78233, United States

Location

University of Virginia Medical Centre

Charlottesville, Virginia, 22908, United States

Location

Mary Immaculate Hospital

Newport News, Virginia, 23602, United States

Location

Bon Secours St Marys Hospital

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Medical Centre

Seattle, Washington, 98122, United States

Location

The Nepean Hospital

Penrith, New South Wales, 2750, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

The Alfred Hospital

Prahran, Victoria, 3004, Australia

Location

Hadassah Medical Centre

Jerusalem, Israel

Location

Sourasky Medical Center (Ichilov)

Tel Aviv, 64239, Israel

Location

Related Publications (2)

Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
PMID: 36318027DERIVED
Jin L, Sun Y, Li Y, Zhang H, Yu W, Li Y, Xin Y, Alsareii SA, Wang Q, Zhang D. A synthetic peptide AWRK6 ameliorates metabolic associated fatty liver disease: involvement of lipid and glucose homeostasis. Peptides. 2021 Sep;143:170597. doi: 10.1016/j.peptides.2021.170597. Epub 2021 Jun 10.
PMID: 34118361DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Results Point of Contact

Title: Neta Tobis, Clinical Director
Organization: Immuron

Study Officials

Dan Peres
Immuron Ltd.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

December 15, 2014

Study Start

December 1, 2014

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

February 21, 2020

Results First Posted

February 21, 2020

Record last verified: 2020-01

Locations

AU(6)IL(2)US(17)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (24)

Other Outcomes (13)

Study Arms (3)

Treatment Arm A

Treatment Arm B

Treatment Arm C

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations