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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis (NASH)

In brief

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.

Key facts

Study ID

NCT02316717

Run by

Immuron Ltd.

People needed

133

Starts

2014-12-01

Expected to finish

2017-10-30

Last updated by the study team

2020-02-21

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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;
• 10% 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;
• 6. 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;
• Ongoing infectious, ongoing multi-systemic immune-mediated and/or concurrent or past malignant disease;
• Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or on the interpretation of the study data;
• Concurrent medications including:
• anti-NASH therapy(s) taken for more than 10 continuous days in the last 3 months. These include S-adenosyl methionine (SAM-e), betaine, milk thistle, probiotic supplements (other than yoghurt), vitamin E and gemfibrozil.
• NB: If vitamin E or gemfibrozil are used, the dose must be stable and liver biopsy confirming diagnosis of NASH subsequent to commencing treatment; commencing treatment;
• Wash out for any of the anti-NASH therapies is as follows: under 10 days no washout required, more than 10 days and up to 3 months treatment requires 6 weeks washout. Any treatment of over 3 months would require to re-biopsy to ensure histological eligibility
• thiazolidinediones (glitazones), dipeptidyl peptidase 4 inhibitors (gliptins) or glucagon-like peptide-1 analogs in the last 6 months. If treatment commenced and is stable for more than 6 month prior to the determinant biopsy and the dose is still stable at time of study entry, subjects will be eligible for recruitment.
• Allowable anti-diabetic treatment includes metformin and/or sulfonylureas administered at constant dose for at least 2 months prior to study entry.
• Subjects treated with Insulin are eligible if clinically stable on insulin treatment (i.e. no recurrent acute hypo-/hyperglycemic episodes diagnosed clinically and by Glucose serum levels of <50 mg/dL and >200 mg/dL respectively) for at least 2 months prior to study entry.
• immune modulatory agents including

Where it is running

• eStudySite — Chula Vista, California, United States
• University of California San Diego — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Florida Hepatology Research at CTRB — Gainesville, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Duke Liver Centre — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Baylor St Lukes Medical Centre — Houston, Texas, United States
• Brooke Army Medical Centre — Houston, Texas, United States
• Pinnacle Clinical Research — Live Oak, Texas, United States
• University of Virginia Medical Centre — Charlottesville, Virginia, United States
• Mary Immaculate Hospital — Newport News, Virginia, United States
• Bon Secours St Marys Hospital — Richmond, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Swedish Medical Centre — Seattle, Washington, United States
• The Nepean Hospital — Penrith, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Box Hill Hospital — Box Hill, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• The Alfred Hospital — Prahran, Victoria, Australia
• Hadassah Medical Centre — Jerusalem, Israel
• Sourasky Medical Center (Ichilov) — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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