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Non-alcoholic Steatohepatitis (NASH)Phase 2NCT02316717

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

A Phase 2 study testing IMM-124E in people with Non-alcoholic Steatohepatitis (NASH), run by Immuron Ltd. at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Non-alcoholic Steatohepatitis (NASH)
What is being tested?
IMM-124E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
25 sitesin 3 countries
Study dates
Dec 2014to 30 Oct 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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);
Show all 42Show fewer
  • 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
  • In the last 3 months:
  • systemic steroids for more than 7 days.
  • daily treatment with multiple non-steroidal anti-inflammatory drugs (such as aspirin >100mg/day, ibuprofen, naproxen, meloxicam, celecoxib) for more than 1 month within 3 months prior to study entry;
  • In the last 12 months:
  • azathioprine, 6-mercaptopurine, methotrexate, cyclosporin, anti-TNFα therapies (infliximab, adalimumab, etanercept) or anti-integrin therapies (namixilab) ;
  • more than 10 consecutive days oral or parenteral antibiotics within 4 weeks prior to study entry (Note: such subjects would not be included in the stool and PBMC analysis).
  • variable dose of antilipidemic agents (3-hydroxy-3-methyl-glutaryl (HMG)-Co-A reductase inhibitors - "statins") in the 3 months prior to study entry.
  • The following laboratory abnormalities:
  • Neutrophil count ≤1.0 x 10^9/L
  • Platelets <100 x 10^9/L
  • Hemoglobin <10 g/dL
  • Albumin <3.5 g/dL
  • International Normalized Ratio (INR) >1.5
  • Total bilirubin >1.5 x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
  • Either creatinine clearance ≤60 mL/minute calculated by Cockroft Gault or creatinine >1.5x upper limit of reference range.
  • Known substance abuse, including inhaled or injected drugs in the year prior to Screening.
  • Cow milk allergy, lactose intolerance or any known or suspected hypersensitivity to study products.

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

United States17 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Virginia Medical Centre

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • eStudySite

    Chula Vista, California, 91911

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke Liver Centre

    Durham, North Carolina, 27710

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Baylor St Lukes Medical Centre

    Houston, Texas, 77030

  • Brooke Army Medical Centre

    Houston, Texas, 78234

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Pinnacle Clinical Research

    Live Oak, Texas, 78233

  • Mary Immaculate Hospital

    Newport News, Virginia, 23602

  • Bon Secours St Marys Hospital

    Richmond, Virginia, 23226

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of California San Diego

    San Diego, California, 92103

  • Quest Clinical Research

    San Francisco, California, 94115

  • Swedish Medical Centre

    Seattle, Washington, 98122

Other trials in United States

Australia6 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • The Nepean Hospital

    Penrith, New South Wales, 2750

  • The Alfred Hospital

    Prahran, Victoria, 3004

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Israel2 sites

  • Hadassah Medical Centre

    Jerusalem

  • Sourasky Medical Center (Ichilov)

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Phase ll, Randomized, Double-blind, Placebo-controlled 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.

Read the 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.

Being tested
IMM-124E, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMM-124EBiological

    IMM-124E

  • PlaceboOther

    Matched placebo

Study groups in NCT02316717
Study groupRoleWhat they receive
Treatment Arm AExperimentalIMM-124E, 600 mg three times daily, orally plus matching placebo
Receives: Biological: IMM-124E
Treatment Arm BExperimentalIMM-124E, 1200 mg three times daily, orally
Receives: Biological: IMM-124E
Treatment Arm CPlacebo comparatorMatching placebo, three times daily, orally
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Outcome Measure

    Incidence of adverse events per arm/group

    Measured: 24 Weeks

  2. 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

    Measured: baseline and 24 weeks

  3. Adverse Events

    Number of patients with treatment-related adverse events

    Measured: 24 weeks

  4. Severity of Adverse Events

    Number of grade 3-5 adverse events

    Measured: 24 weeks

Secondary outcomes (24)

  1. Systolic Blood Pressure

    Mean change in Systolic Blood Pressure

    Measured: baseline and 24 weeks

  2. Pulse Rate

    Mean change in Pulse Rate from baseline to week 24

    Measured: baseline and 24 weeks

  3. Diastolic Blood Pressure

    Change in Diastolic Blood Pressure

    Measured: baseline and 24 weeks

  4. Respiratory Rate

    Mean change in Respiratory Rate from baseline to week 24

    Measured: baseline and 24 weeks

  5. Serum Alanine Aminotransaminase (ALT)

    Mean change from Baseline in Serum Alanine Aminotransaminase (ALT) at Week 24

    Measured: baseline and 24 weeks

  6. Peak Serum Concentration (Cmax)

    Peak serum concentration (Cmax) of IMM-124E

    Measured: 0, 4, 12 and 24 Weeks

  7. Minimum Serum Concentration (Cmin)

    Minimum serum concentration (Cmin) of IMM-124E

    Measured: 0, 4, 12 and 24 Weeks

  8. Area Under the Concentration Time Curve (AUC)

    Area Under the Concentration Time Curve (AUC) of IMM-124E. Time points at which data were collected: baseline pre-dose, week 4, week 12 and week 24.

    Measured: 0, 4, 12 and 24 Weeks

  9. Elimination Half Life (T1/2)

    Elimination Half Life (T1/2) of IMM-124E

    Measured: 0, 4, 12 and 24 Weeks

  10. Body Mass Index (BMI)

    Change from Baseline of Body Mass Index (BMI) at 24 weeks

    Measured: 24 Weeks

  11. Waist Circumference

    Change from Baseline of Waist Circumference at 24 weeks

    Measured: 24 Weeks

  12. Waist:Hip Ratio

    Change from Baseline of Waist:Hip Ratio at 24 weeks

    Measured: 24 Weeks

  13. Hemoglobin (HB)A1C

    Change from Baseline of Hemoglobin(HB)A1C at 24 weeks

    Measured: 24 Weeks

  14. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Change from Baseline of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 24 weeks

    Measured: baseline and 24 Weeks

  15. Total Cholesterol

    Change from Baseline of Total Cholesterol at 24 weeks

    Measured: 24 Weeks

  16. Triglycerides

    Change from Baseline of Triglycerides at 24 weeks

    Measured: 24 Weeks

  17. Low Density Lipoprotein (LDL)

    Change from Baseline of Low Density Lipoprotein (LDL) at 24 weeks

    Measured: 24 Weeks

  18. High Density Lipoprotein (HDL)

    Change from Baseline of High Density Lipoprotein (HDL) at 24 weeks

    Measured: 24 Weeks

  19. Serum Alanine Aminotransaminase (ALT)

    Mean change from Baseline of serum ALT

    Measured: baseline to 24 weeks

  20. Serum Aspartate Aminotransaminase (AST)

    Mean change from Baseline of Serum AST

    Measured: baseline to 24 Weeks

  21. Bilirubin

    Mean change from Baseline of Bilirubin

    Measured: baseline to 24 Weeks

  22. Albumin

    Mean change from Baseline of Albumin

    Measured: baseline to 24 Weeks

  23. Gamma Glutamyl Transpeptidase (GGT)

    Mean change from Baseline of Gamma Glutamyl Transpeptidase (GGT)

    Measured: baseline to 24 Weeks

  24. Serum Alanine Aminotransaminase (ALT)

    Number of patients with ALT within the normal reference range at Week 24 (defined a <19 IU/L for women and <30 IU/L for men)

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion30 Oct 2017
  4. Study completion30 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02316717
Sponsor's protocol ID
IMM-124E-2001
Status last verified
Jan 2020
First submitted
6 Nov 2014
Last updated
21 Feb 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 36318027

  • 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.

    PubMed 34118361

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMM-124E in people with Non-alcoholic Steatohepatitis (NASH), run by Immuron Ltd. at 25 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Australia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcome Measure (time frame: 24 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02316717, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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