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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316717
Recruitment Status : Completed
First Posted : December 15, 2014
Results First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Immuron Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Non-alcoholic Steatohepatitis (NASH)
Interventions Biological: IMM-124E
Other: Placebo
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Period Title: Overall Study
Started 43 46 44
Completed 32 39 41
Not Completed 11 7 3
Reason Not Completed
Adverse Event             2             2             0
Lost to Follow-up             1             2             1
Non compliance             3             1             0
Protocol Violation             2             0             0
Withdrawal by Subject             2             1             1
Death             0             0             1
Physician Decision             0             1             0
TBC             1             0             0
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C Total
Hide Arm/Group Description

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Total of all reporting groups
Overall Number of Baseline Participants 43 46 44 133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 46 participants 44 participants 133 participants
51.4  (11.9) 50.2  (13.7) 50.2  (11.1) 50.59  (12.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 44 participants 133 participants
Female
23
  53.5%
27
  58.7%
20
  45.5%
70
  52.6%
Male
20
  46.5%
19
  41.3%
24
  54.5%
63
  47.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 44 participants 133 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.3%
1
   0.8%
Asian
6
  14.0%
1
   2.2%
1
   2.3%
8
   6.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   2.3%
1
   0.8%
Black or African American
0
   0.0%
1
   2.2%
0
   0.0%
1
   0.8%
White
30
  69.8%
40
  87.0%
34
  77.3%
104
  78.2%
More than one race
2
   4.7%
2
   4.3%
2
   4.5%
6
   4.5%
Unknown or Not Reported
5
  11.6%
2
   4.3%
5
  11.4%
12
   9.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 46 participants 44 participants 133 participants
United States 34 32 34 100
Israel 1 6 5 12
Australia 8 8 5 21
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 43 participants 46 participants 44 participants 133 participants
33.97  (5.439) 34.12  (5.802) 34.54  (5.678) 34.21  (5.653)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 43 participants 46 participants 44 participants 133 participants
6.14  (0.765) 6.16  (0.999) 6.12  (0.916) 6.141  (0.896)
Hepatic Fat  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 43 participants 46 participants 44 participants 133 participants
19.64  (9.237) 19.11  (8.166) 18.39  (7.067) 19.04  (8.219)
1.Primary Outcome
Title Safety Outcome Measure
Hide Description Incidence of adverse events per arm/group
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of treatment emerged AEs per arm/group
Arm/Group Title IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Hide Arm/Group Description:
IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
Matching placebo, three times daily, orally 24 weeks of treatment
Overall Number of Participants Analyzed 43 46 44
Measure Type: Number
Unit of Measure: AEs
185 207 155
2.Primary Outcome
Title Percentage Fat Content of the Liver
Hide Description Mean change from Baseline in Percentage Fat Content of the Liver measured by Magnetic Resonance Imaging (MRI) at Week 24
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes subjects with both baseline MRI and week 24 MRI.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 35 40 41
Mean (Standard Deviation)
Unit of Measure: percentage of hepatic fat fraction
-1.55  (0.903) -0.90  (0.818) -1.85  (0.810)
3.Primary Outcome
Title Adverse Events
Hide Description Number of patients with treatment-related adverse events
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with any treatment-related AE
Arm/Group Title IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Hide Arm/Group Description:
IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
Matching placebo, three times daily, orally 24 weeks of treatment
Overall Number of Participants Analyzed 43 46 44
Measure Type: Count of Participants
Unit of Measure: Participants
17
  39.5%
14
  30.4%
13
  29.5%
4.Primary Outcome
Title Severity of Adverse Events
Hide Description Number of grade 3-5 adverse events
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of grade 3-5 AEs
Arm/Group Title IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Hide Arm/Group Description:
IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
Matching placebo, three times daily, orally 24 weeks of treatment
Overall Number of Participants Analyzed 43 46 44
Measure Type: Number
Unit of Measure: events
12 10 7
5.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Mean change in Systolic Blood Pressure
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population include subjects with data of both baseline and week 24
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 41
Mean (Standard Deviation)
Unit of Measure: mmHg
6.1  (16.19) 2.0  (12.73) 0.2  (14.75)
6.Secondary Outcome
Title Pulse Rate
Hide Description Mean change in Pulse Rate from baseline to week 24
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population include subjects with Pulse Rate data of both baseline and week 24
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 41
Mean (Standard Deviation)
Unit of Measure: beats/minute
-0.8  (10.91) -1.9  (9.29) 2.1  (10.00)
7.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description Change in Diastolic Blood Pressure
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population include subjects with data of both baseline and week 24
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 41
Mean (Standard Deviation)
Unit of Measure: mmHg
0.6  (11.17) -0.5  (6.40) -0.3  (8.37)
8.Secondary Outcome
Title Respiratory Rate
Hide Description Mean change in Respiratory Rate from baseline to week 24
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes subjects with both respiratory rate data at baseline and week 24
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 41
Mean (Standard Deviation)
Unit of Measure: breaths/minute
-0.2  (1.63) -0.3  (1.68) 0.1  (2.08)
9.Secondary Outcome
Title Serum Alanine Aminotransaminase (ALT)
Hide Description Mean change from Baseline in Serum Alanine Aminotransaminase (ALT) at Week 24
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: IU/L
-14.4  (4.95) -10.7  (4.55) -10.3  (4.49)
10.Secondary Outcome
Title Peak Serum Concentration (Cmax)
Hide Description Peak serum concentration (Cmax) of IMM-124E
Time Frame 0, 4, 12 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: ng/mL
0  (0) 0  (0) 0  (0)
11.Secondary Outcome
Title Minimum Serum Concentration (Cmin)
Hide Description Minimum serum concentration (Cmin) of IMM-124E
Time Frame 0, 4, 12 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: ng/mL
0  (0) 0  (0) 0  (0)
12.Secondary Outcome
Title Area Under the Concentration Time Curve (AUC)
Hide Description 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.
Time Frame 0, 4, 12 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: ng/mL
0  (0) 0  (0) 0  (0)
13.Secondary Outcome
Title Elimination Half Life (T1/2)
Hide Description Elimination Half Life (T1/2) of IMM-124E
Time Frame 0, 4, 12 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: seconds
0  (0) 0  (0) 0  (0)
14.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description Change from Baseline of Body Mass Index (BMI) at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.20  (1.024) -0.33  (1.701) 0.09  (1.350)
15.Secondary Outcome
Title Waist Circumference
Hide Description Change from Baseline of Waist Circumference at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 21 33 29
Mean (Standard Deviation)
Unit of Measure: cm
-1.20  (4.353) -0.35  (5.969) -0.92  (6.090)
16.Secondary Outcome
Title Waist:Hip Ratio
Hide Description Change from Baseline of Waist:Hip Ratio at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 21 33 29
Mean (Standard Deviation)
Unit of Measure: ratio
-0.02  (0.051) 0.01  (0.063) 0.01  (0.079)
17.Secondary Outcome
Title Hemoglobin (HB)A1C
Hide Description Change from Baseline of Hemoglobin(HB)A1C at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 36 39
Mean (Standard Deviation)
Unit of Measure: percentage
1.0  (0.88) 0.1  (0.84) 0.2  (0.81)
18.Secondary Outcome
Title Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description Change from Baseline of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 24 weeks
Time Frame baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
HOMA-IR is calculated according to the formula: fasting insulin (mU/mL) x fasting glucose (mmol/L)/22.5
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 30 36 35
Mean (Standard Deviation)
Unit of Measure: no unit
2.098  (2.3374) 0.057  (2.1340) 0.655  (2.1648)
19.Secondary Outcome
Title Total Cholesterol
Hide Description Change from Baseline of Total Cholesterol at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.1  (0.11) 0.0  (0.10) 0.0  (0.10)
20.Secondary Outcome
Title Triglycerides
Hide Description Change from Baseline of Triglycerides at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.7  (1.25) -0.3  (1.15) -0.4  (1.14)
21.Secondary Outcome
Title Low Density Lipoprotein (LDL)
Hide Description Change from Baseline of Low Density Lipoprotein (LDL) at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 30 37 37
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.1  (0.09) 0.1  (0.08) 0.0  (0.08)
22.Secondary Outcome
Title High Density Lipoprotein (HDL)
Hide Description Change from Baseline of High Density Lipoprotein (HDL) at 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.0  (0.03) 0.0  (0.02) 0.1  (0.02)
23.Secondary Outcome
Title Serum Alanine Aminotransaminase (ALT)
Hide Description Mean change from Baseline of serum ALT
Time Frame baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: IU/L
-14.4  (4.95) -10.7  (4.55) -10.3  (4.49)
24.Secondary Outcome
Title Serum Aspartate Aminotransaminase (AST)
Hide Description Mean change from Baseline of Serum AST
Time Frame baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: IU/L
-7.8  (3.32) -7.4  (3.05) -7.5  (3.01)
25.Secondary Outcome
Title Bilirubin
Hide Description Mean change from Baseline of Bilirubin
Time Frame baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: umol/l
-1.0  (3.56) -1.0  (0.54) 0.3  (0.53)
26.Secondary Outcome
Title Albumin
Hide Description Mean change from Baseline of Albumin
Time Frame baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.8  (0.35) -0.2  (0.32) 0.3  (0.32)
27.Secondary Outcome
Title Gamma Glutamyl Transpeptidase (GGT)
Hide Description Mean change from Baseline of Gamma Glutamyl Transpeptidase (GGT)
Time Frame baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Mean (Standard Deviation)
Unit of Measure: U/L
-7.1  (5.03) -9.7  (4.62) -5.7  (4.56)
28.Secondary Outcome
Title Serum Alanine Aminotransaminase (ALT)
Hide Description 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)
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 40
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
4
  10.3%
2
   5.0%
29.Other Pre-specified Outcome
Title Serum Concentrations of Lipopolysaccharide (LPS)
Hide Description The percentage of subjects reporting at least 15% reduction in LPS, from baseline to Week 24
Time Frame 0, 4, 12 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
excluding subjects with < 250 LPS at baseline (comparing 1200mg IMP group to Placebo group). PP population, excluding outliers sites. this Outcome Measure was pre-specified to be assessed in the 1200mg and Placebo Arms/Groups *only*
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 0 28 29
Measure Type: Count of Participants
Unit of Measure: Participants
18
  64.3%
10
  34.5%
30.Other Pre-specified Outcome
Title Regulatory T Cells (FoxP3+ CD25-CD4+) in Peripheral Blood Mononuclear Cells
Hide Description Change in percent of FoxP3+ CD25-CD4+ cells in Peripheral Blood Mononuclear Cells
Time Frame 0 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Sub group population with PBMC FACS data, selected sites only.
Arm/Group Title IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Hide Arm/Group Description:
IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
Matching placebo, three times daily, orally 24 weeks of treatment
Overall Number of Participants Analyzed 1 8 3
Mean (Standard Deviation)
Unit of Measure: percentage of cells
NA [1]   (NA) 0.46  (0.26) 14.59  (14.58)
[1]
only 1 participant's data analyzed in 600mg arm.
31.Other Pre-specified Outcome
Title Gut Microbiome From Fecal Samples
Hide Description Number of participants with measurable differences in gut microbiome constituents post-treatment
Time Frame 0, 4, 12 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 4 12 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
32.Other Pre-specified Outcome
Title Serum Concentrations of LPS
Hide Description Serum Concentrations of Lipopolysaccharide (LPS) (ng/mL) levels and change from Baseline
Time Frame baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 12 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 33 39 35
Mean (Standard Deviation)
Unit of Measure: ng/mL
-130.763  (188.153) 78.488  (173.029) 414.912  (182.632)
33.Other Pre-specified Outcome
Title Serum Concentrations of C-Reactive Protein (CRP)
Hide Description Mean Serum Concentrations of C-Reactive Protein (CRP) at week 24
Time Frame baseline to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
assessed at 0, 4, 12 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 35 40 41
Mean (Standard Deviation)
Unit of Measure: mg/L
0.711  (0.68) 1.129  (1.637) 1.364  (2.317)
34.Other Pre-specified Outcome
Title Serum Concentrations of CK-18 Fragments
Hide Description The proportion of subjects with significant reduction of CK-18 (≥ 15%) between IMP 1200mg group to placebo.
Time Frame baseline to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, excluding outlier sites. this Outcome Measure was pre-specified to be assessed in the 1200mg and Placebo Arms/Groups *only*
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 0 36 33
Measure Type: Count of Participants
Unit of Measure: Participants
14
  38.9%
6
  18.2%
35.Other Pre-specified Outcome
Title Serum Concentrations of Human Adiponectin
Hide Description Change from Run-in to Post-treatment in serum concentration of human Adiponectin.
Time Frame 0 to 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Run-in = mean of screening and baseline values. assessed at 0, 4, 12 and 24 Weeks, change from baseline to week 24 reported
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 38 43 37
Mean (Standard Deviation)
Unit of Measure: pg/mL
107560.15  (1082735.0) 208185.48  (1115352.8) 1082735.0  (1900710.5)
36.Other Pre-specified Outcome
Title Serum Concentrations of Cytokine IL-6
Hide Description Mean Change from baseline to week 24 of serum concentration of cytokine IL-6
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 36 41 39
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.1234  (0.90505) 0.1031  (1.63948) 0.4117  (1.50248)
37.Other Pre-specified Outcome
Title Serum Concentration of Cytokine IL-12p70
Hide Description Mean change from baseline to week 24 of Serum concentration of Cytokine IL-12p70
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 36 41 39
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.0494  (1.00060) 0.3274  (2.76062) 0.0579  (1.35852)
38.Other Pre-specified Outcome
Title Serum Concentration of Interferon Gamma (IFN-γ)
Hide Description Mean Change from baseline to week 24 of serum concentration of IFN-gamma
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 36 41 39
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.9523  (6.25581) 0.8058  (6.59164) 1.4514  (7.56336)
39.Other Pre-specified Outcome
Title Serum Concentration of Tumor Necrosis Factor Alpha (TNF-α)
Hide Description Mean Change from baseline to week 24 of serum concentration of TNF-α
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 36 41 39
Mean (Standard Deviation)
Unit of Measure: pg/mL
-0.1691  (1.68068) -0.5082  (1.59892) -0.3877  (2.16469)
40.Other Pre-specified Outcome
Title Serum Concentration of Glucagon-like Peptide-1 (GLP-1)
Hide Description Mean Change from baseline to week 24 of serum concentration of GLP-1
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment Arm A Treatment Arm B Treatment Arm C
Hide Arm/Group Description:

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

IMM-124E: IMM-124E

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

IMM-124E: IMM-124E

Matching placebo, three times daily, orally

Placebo: Matched placebo

Overall Number of Participants Analyzed 37 41 39
Mean (Standard Deviation)
Unit of Measure: pM
1.6457  (15.79917) -1.5310  (13.07262) 3.4820  (33.36977)
41.Other Pre-specified Outcome
Title Regulatory T Cells (FoxP3+CD25-CD8+) in Peripheral Blood Mononuclear Cells
Hide Description Change in percent of FoxP3+CD25-CD8+ cells in Peripheral Blood Mononuclear Cells
Time Frame 0 and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Sub group population with PBMC FACS data, selected sites only.
Arm/Group Title IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Hide Arm/Group Description:
IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment
IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment
Matching placebo, three times daily, orally 24 weeks of treatment
Overall Number of Participants Analyzed 1 8 3
Mean (Standard Deviation)
Unit of Measure: percentage of cells
NA [1]   (NA) -0.01  (0.33) 12.52  (12.32)
[1]
only 1 participant's data analyzed in 600mg arm.
Time Frame 28 weeks after participant received first dose
Adverse Event Reporting Description

The adverse event information collected in the clinical study is collected based on the adverse event definition of ''Results Data Element Definitions for Adverse Events''.

The adverse events data was collected based on physician's assessments, laboratory assessments, subjects reporting and questionnaires.

 
Arm/Group Title IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Hide Arm/Group Description IMM-124E, 600 mg three times daily, orally plus matching placebo 24 weeks of treatment IMM-124E, 1200 mg three times daily, orally 24 weeks of treatment Matching placebo, three times daily, orally 24 weeks of treatment
All-Cause Mortality
IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)      0/46 (0.00%)      1/44 (2.27%)    
Hide Serious Adverse Events
IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/43 (2.33%)      2/46 (4.35%)      3/44 (6.82%)    
General disorders       
Chest Pain  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/44 (0.00%)  0
Injury, poisoning and procedural complications       
Road traffic accident  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1
Investigations       
Blood creatine phosphokinase increased  1  0/43 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Transitional cell carcinoma  1  1/43 (2.33%)  1 0/46 (0.00%)  0 0/44 (0.00%)  0
Product Issues       
Anxiety  1  0/43 (0.00%)  0 1/46 (2.17%)  1 0/44 (0.00%)  0
Surgical and medical procedures       
Hospitalisation  1 [1]  0/43 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
[1]
Psychiatric hospitalisation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IMM-124E, 600 mg IMM-124E, 1200 mg Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/43 (90.70%)      41/46 (89.13%)      38/44 (86.36%)    
Gastrointestinal disorders       
Nausea  1  8/43 (18.60%)  10 15/46 (32.61%)  16 11/44 (25.00%)  16
Diarrhoea  1  11/43 (25.58%)  16 8/46 (17.39%)  17 8/44 (18.18%)  10
Abdominal distension  1  4/43 (9.30%)  4 6/46 (13.04%)  6 2/44 (4.55%)  2
Abdominal discomfort  1  0/43 (0.00%)  0 3/46 (6.52%)  4 0/44 (0.00%)  0
Abdominal pain  1 [1]  8/43 (18.60%)  11 6/46 (13.04%)  8 9/44 (20.45%)  10
Constipation  1  4/43 (9.30%)  6 7/46 (15.22%)  8 4/44 (9.09%)  4
Flatulence  1  5/43 (11.63%)  5 5/46 (10.87%)  6 4/44 (9.09%)  5
Vomiting  1  4/43 (9.30%)  4 3/46 (6.52%)  4 5/44 (11.36%)  7
General disorders       
Fatigue  1  8/43 (18.60%)  10 3/46 (6.52%)  3 3/44 (6.82%)  3
Infections and infestations       
Gastroenteritis  1  0/43 (0.00%)  0 3/46 (6.52%)  3 2/44 (4.55%)  2
Nasopharyngitis  1  2/43 (4.65%)  2 3/46 (6.52%)  3 2/44 (4.55%)  5
Sinusitis  1  2/43 (4.65%)  3 3/46 (6.52%)  4 2/44 (4.55%)  2
Upper respiratory tract infection  1  2/43 (4.65%)  2 5/46 (10.87%)  6 5/44 (11.36%)  5
Injury, poisoning and procedural complications       
Limb injury  1  0/43 (0.00%)  0 0/46 (0.00%)  0 3/44 (6.82%)  4
Investigations       
Blood creatine phosphokinase increased  1  0/43 (0.00%)  0 3/46 (6.52%)  3 2/44 (4.55%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/43 (11.63%)  5 5/46 (10.87%)  5 3/44 (6.82%)  3
Muscle spasms  1  0/43 (0.00%)  0 4/46 (8.70%)  5 0/44 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/43 (2.33%)  1 5/46 (10.87%)  7 1/44 (2.27%)  2
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  3/43 (6.98%)  3 0/46 (0.00%)  0 0/44 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus  1  2/43 (4.65%)  2 6/46 (13.04%)  6 2/44 (4.55%)  2
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
[1]
lower and/or upper
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neta Tobis, Clinical Director
Organization: Immuron
Phone: +972549277334 ext 2549277334
EMail: neta@immuron.com
Layout table for additonal information
Responsible Party: Immuron Ltd.
ClinicalTrials.gov Identifier: NCT02316717    
Other Study ID Numbers: IMM-124E-2001
First Submitted: November 6, 2014
First Posted: December 15, 2014
Results First Submitted: January 7, 2020
Results First Posted: February 21, 2020
Last Update Posted: February 21, 2020