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| Name | Class |
|---|---|
| Integrium | INDUSTRY |
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This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM. The study will consist of a Screening Phase, Placebo Run-in Phase, Treatment Phase and an End-of-Study Phase. Approximately 36 subjects will be randomized in a 2:1 ratio to receive either 8 mg ORMD-0801, 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) or matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Fish oil |
|
| ORMD-0801 (Insulin) capsule 8 mg BD | Experimental | ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORMD-0801 (Insulin) capsule 8 mg BD | Drug | 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Adverse Events | The Number of Treatment-Emergent Adverse Events (TEAE) according to CTCAE version 4.03. A TEAE is an adverse event for which the start date is on or after the date that the treatment began. | Screening through Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Median MRPDFF at Baseline and Week 12 of Whole Liver | Median MRPDFF at Baseline and Week 12 of Whole Liver. Delineation by a central radiologist of the whole liver in the slice with the largest liver cross-section. The Liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI. | Baseline and Week 12 (Visit 8) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with active (acute or chronic) liver disease other than NASH (e.g. viral hepatitis, genetic hemochromatosis, Wilson disease, alpha-1 antitrypsin deficiency, alcohol liver disease, drug-induced liver disease) at the time of enrolment.
ALT or AST > 5 times ULN.
Abnormal synthetic liver function (serum albumin ≤3.5gm%, INR >1.3).
Known alcohol and/or any other drug abuse or dependence in the last five years.
Weight >120 Kg (264.6 lbs.)
Known history or presence of clinically significant, cardiovascular, gastrointestinal, metabolic (other than diabetes mellitus), neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder, or nephrotic syndrome.
History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolites (e.g. inflammatory bowel disease (IBD), previous intestinal (ileal or colonic) operation, chronic pancreatitis, celiac disease, or previous vagotomy.
Weight loss of more than 5% within 6 months prior to enrolment.
History of bariatric surgery.
Uncontrolled blood pressure BP ≥150/≥95.
Non-type 2 DM (type 1, endocrinopathy, genetic syndromes etc.).
Patients with HIV.
Daily alcohol intake >20 g/day (2 units/day) for women and >30 g/day (3 units/day) for men.
Treatment with anti-diabetic medications other than metformin and more than two of the following medications sulfonylurea, DPP-4 inhibitors, GLP-1 receptor agonists, TZDs
Metformin, fibrates, statins, not provided on a stable dose in the last 6 months.
Patients who are treated with valproic acid, Tamoxifen, methotrexate, amiodarone.
Chronic treatment with antibiotics (e.g. Rifaximin).
Homeopathic and/or Alternative treatments. Any treatment must be stopped before the screening period.
Uncontrolled hypothyroidism defined as Thyroid Stimulating Hormone >2X the upper limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to screening is permitted.
Patients with renal dysfunction: eGFR< 40 ml/min.
Unexplained serum creatinine phosphokinase (CPK) >3X the upper limit of normal (ULN). Patients with a reason for CPK elevation may have the measurement repeated prior to enrolment; a CPK retest > 3X ULN leads to exclusion.
Subjects meeting criteria for contraindication for MRI - including the following:
i. History of severe claustrophobia impacting the ability to perform MRI during the study, even despite mild sedation/treatment with as anxiolytic.
ii. Subjects with metal implants, devices, paramagnetic objects contained within the body, and excessive or metal-containing tattoos.
iii. Subjects unable to lie still within the environment of the MRI scanner or maintain a breath-hold for the required period to acquire images, even despite mild sedation/treatment with an anxiolytic.
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Kidron, Ph.D. | Oramed, Ltd. | Study Director |
| Joel M Neutel, M. D. | Integrium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Hadassah Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28116801 | Background | Lin SC, Heba E, Bettencourt R, Lin GY, Valasek MA, Lunde O, Hamilton G, Sirlin CB, Loomba R. Assessment of treatment response in non-alcoholic steatohepatitis using advanced magnetic resonance imaging. Aliment Pharmacol Ther. 2017 Mar;45(6):844-854. doi: 10.1111/apt.13951. Epub 2017 Jan 24. | |
| 22488764 | Background |
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All screened participants must have an MRI scan prior to enrollment to confirm satisfying the entry criteria of MR PDFF >= 8%
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Fish oil Placebo: Matching Placebo |
| FG001 | ORMD-0801 (Insulin) Capsule 8 mg BD | ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral ORMD-0801 (Insulin) capsule 8 mg BD: 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2020 |
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The study will consist of a Screening Phase, Placebo Run-in Phase, Treatment Phase, and an End-of-Study Phase. Approximately 36 subjects will be randomized in a 2:1 ratio to receive either 8 mg ORMD-0801, 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) or matching placebo.
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| Placebo | Other | Matching Placebo |
|
|
| Percent Change From Baseline of Median MRPDFF of Whole Liver |
The percent change in MR PDFF from baseline to Week 12 of Whole Liver |
| Baseline and Week 12 (Visit 8) |
| Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver at Baseline and Week12. The Whole liver was delineated by a central radiologist. The liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI. | Baseline and Week 12 |
| Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | The percent change from basline in liver fat content as measured by the mean MRI Proton density Fat Fraction (MR PDFF) at baseline and at week 12 of Whole Liver | Screening and Week 12 (Visit 8) |
| Median Magnetic Resonance Proton Density Fat Fraction (MR PDFF) of Liver Segment 3 | Median MRPDFF (percentage fat in the liver) of liver segment 3 as measured by MRI Proton Density Fat Fraction at baseline and at week 12. Delineation by a central radiologist of the Liver Segment 3 in the slice with the largest Liver Segment 3 cross-section. | Baseline and Week 12 (Visit 8) |
| Percent Change From Baseline of Median MRPDFF of Liver Segment 3 | Percent Change from Baseline Median MRPDFF of Liver Segment measured at baseline and Week 12 (Visit 8) | Baseline and Week 12 (Visit 8) |
| Mean MRPDFF of Liver Segment 3 | Mean MRPDFF of Liver Segment measured at baseline and Week 12 | Baseline and Week 12 (Visit 8) |
| Percent Change of Mean MRPDFF of Liver Segment 3 | Percent change from baseline of mean MR PDFF measurement of liver segment 3 at baseline and week 12 | Baseline and Week 12 (Visit 8) |
| Median MR PDFF of Liver Segment 6 | Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 6 in the slice with the largest Liver Segment 6 cross-section. | Screening and Week 12 (Visit 8) |
| Percent Change From Baseline of Median MR PDFF of Liver Segment 6 | Percent Change from Baseline of Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 | Screening and Week 12 (Visit 8) |
| Mean MR PDFF of Liver Segment 6 | Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8) | Screening and Week 12 (Visit 8) |
| Percent Change From Baseline of Mean MR PDFF of Liver Segment 6 | Percent Change from Baseline Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8) | Screening and Week 12 (Visit 8) |
| Median MRPDFF of Liver Segment 8 | Median MRPDFF of Liver Segment 8 measured at baseline and Week 12 (Visit 8) | Baseline and Week 12 (Visit 8) |
| Percent Change in Median MRPDFF of Liver Segment 8 | Percent change from baseline in median MRPDFF of Liver segment 8 measured at baseline and week 12 (Visit 8). | Baseline and Week 12 (Visit 8) |
| Mean MRPDFF of Liver Segment 8 | Liver fat percentage of liver segment 8 as measured by MRI Proton Density Fat Fraction (MR PDFF) at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 8 in the slice with the largest Liver Segment 8 cross-section. | Baseline and Week 12 (Visit 8) |
| Percent Change From Baseline in Mean MRPDFF of Liver Segment 8 | Percent change from baseline in MRPDFF of liver segment 8 at baseline and at week 12 (Visit 8) | Baseline and Week 12 (Visit 8) |
| Liver Steatosis | Liver steatosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M) | Baseline and Week 12 (Visit 8) |
| Change in Liver Steatosis From Baseline | Change in Liver steatosis from baseline measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M) | Baseline and Week 12 (Visit 8) |
| Liver Fibrosis | Liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa). | Baseline and Week 12 (Visit 8) |
| Change From Baseline of Liver Fibrosis | The change from baseline in liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa). | Baseline and Week 12 (Visit 8) |
| Jerusalem |
| International/Other |
| Israel |
| Tel Aviv Sourasky Medical Center- Ichilov Hospital | Tel Aviv | International/Other | 6423906 | Israel |
| Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available. |
| 20494470 | Background | Ratziu V, Bellentani S, Cortez-Pinto H, Day C, Marchesini G. A position statement on NAFLD/NASH based on the EASL 2009 special conference. J Hepatol. 2010 Aug;53(2):372-84. doi: 10.1016/j.jhep.2010.04.008. Epub 2010 May 7. No abstract available. |
| 21623852 | Background | Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30. |
| 24388431 | Background | Germain T, Favelier S, Cercueil JP, Denys A, Krause D, Guiu B. Liver segmentation: practical tips. Diagn Interv Imaging. 2014 Nov;95(11):1003-16. doi: 10.1016/j.diii.2013.11.004. Epub 2013 Dec 30. |
| 39131144 | Derived | Ishay Y, Neutel J, Kolben Y, Gelman R, Arbib OS, Lopez O, Katchman H, Mohseni R, Kidron M, Ilan Y. Oral Insulin Alleviates Liver Fibrosis and Reduces Liver Steatosis in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes: Results of Phase II Randomized, Placebo-controlled Feasibility Clinical Trial. Gastro Hep Adv. 2023 Dec 7;3(3):417-425. doi: 10.1016/j.gastha.2023.11.016. eCollection 2024. |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Fish oil Placebo: Matching Placebo |
| BG001 | ORMD-0801 (Insulin) Capsule 8 mg BD | ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral ORMD-0801 (Insulin) capsule 8 mg BD: 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
| |||||||||||||||
| Childbearing Status | Count of Participants | Participants |
| ||||||||||||||||
| Median Magnetic Resonance Proton Fat Fraction (MRPDFF) | Median Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Liver Segment 3, according to the Couinaud classification of hepatic segments. | Median | Full Range | percent liver fat |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment-Emergent Adverse Events | The Number of Treatment-Emergent Adverse Events (TEAE) according to CTCAE version 4.03. A TEAE is an adverse event for which the start date is on or after the date that the treatment began. | Safety Population | Posted | Number | Adverse Events | Screening through Week 16 |
|
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| Secondary | Median MRPDFF at Baseline and Week 12 of Whole Liver | Median MRPDFF at Baseline and Week 12 of Whole Liver. Delineation by a central radiologist of the whole liver in the slice with the largest liver cross-section. The Liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI. | Intent-to-Treat. Placebo population: One subject's baseline Whole Liver MRPDFF was missing. This patient did have their Visit 8 MRI, however since there was no baseline MRPDFF Whole Liver, the change from baseline measurement cannot be calculated. A second patient did not have their Visit 8 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | Percent fat (MRPDFF) | Baseline and Week 12 (Visit 8) |
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline of Median MRPDFF of Whole Liver | The percent change in MR PDFF from baseline to Week 12 of Whole Liver | Intent-to-Treat. Placebo population: One subject's baseline Whole Liver MRPDFF was missing. This patient did have their Visit 8 MRI, however since there was no baseline MRPDFF Whole Liver, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percent change | Baseline and Week 12 (Visit 8) |
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| Secondary | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver at Baseline and Week12. The Whole liver was delineated by a central radiologist. The liver was subdivided into 8 sections according to the Coinaud liver segmentation for MRI. | Intent-to-Treat. Placebo population: One subject's baseline Whole Liver MRPDFF was missing. This patient did have their Visit 8 MRI, however since there was no baseline MRPDFF Whole Liver, the change from baseline measurement cannot be calculated. A second patient did not have their Visit 8 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | percentage of fat | Baseline and Week 12 |
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| Secondary | Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | The percent change from basline in liver fat content as measured by the mean MRI Proton density Fat Fraction (MR PDFF) at baseline and at week 12 of Whole Liver | Intent-to-Treat. Placebo population: One subject's baseline Whole Liver MRPDFF was missing. This patient did have their Visit 8 MRI, however since there was no baseline MRPDFF Whole Liver, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | Percentage of change in MRPDFF | Screening and Week 12 (Visit 8) |
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| Secondary | Median Magnetic Resonance Proton Density Fat Fraction (MR PDFF) of Liver Segment 3 | Median MRPDFF (percentage fat in the liver) of liver segment 3 as measured by MRI Proton Density Fat Fraction at baseline and at week 12. Delineation by a central radiologist of the Liver Segment 3 in the slice with the largest Liver Segment 3 cross-section. | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 3 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percentage fat | Baseline and Week 12 (Visit 8) |
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| Secondary | Percent Change From Baseline of Median MRPDFF of Liver Segment 3 | Percent Change from Baseline Median MRPDFF of Liver Segment measured at baseline and Week 12 (Visit 8) | ntent-to-Treat. Placebo population: One subject's baseline Liver Segment 3 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percentage change | Baseline and Week 12 (Visit 8) |
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| Secondary | Mean MRPDFF of Liver Segment 3 | Mean MRPDFF of Liver Segment measured at baseline and Week 12 | Intent to Treat | Posted | Mean | Standard Deviation | percentage fat | Baseline and Week 12 (Visit 8) |
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| Secondary | Percent Change of Mean MRPDFF of Liver Segment 3 | Percent change from baseline of mean MR PDFF measurement of liver segment 3 at baseline and week 12 | ntent-to-Treat. Placebo population: One subject's baseline Liver Segment 3 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | percentage of Change in MR PDFF | Baseline and Week 12 (Visit 8) |
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| Secondary | Median MR PDFF of Liver Segment 6 | Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 6 in the slice with the largest Liver Segment 6 cross-section. | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 6 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percentage of liver fat | Screening and Week 12 (Visit 8) |
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| Secondary | Percent Change From Baseline of Median MR PDFF of Liver Segment 6 | Percent Change from Baseline of Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 6 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percent change | Screening and Week 12 (Visit 8) |
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| Secondary | Mean MR PDFF of Liver Segment 6 | Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8) | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 6 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | percentage liver fat | Screening and Week 12 (Visit 8) |
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| Secondary | Percent Change From Baseline of Mean MR PDFF of Liver Segment 6 | Percent Change from Baseline Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8) | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 6 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | percent change | Screening and Week 12 (Visit 8) |
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| Secondary | Median MRPDFF of Liver Segment 8 | Median MRPDFF of Liver Segment 8 measured at baseline and Week 12 (Visit 8) | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 8 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percentage liver fat | Baseline and Week 12 (Visit 8) |
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| Secondary | Percent Change in Median MRPDFF of Liver Segment 8 | Percent change from baseline in median MRPDFF of Liver segment 8 measured at baseline and week 12 (Visit 8). | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 8 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Median | Full Range | percent change of the median MRPDFF | Baseline and Week 12 (Visit 8) |
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| Secondary | Mean MRPDFF of Liver Segment 8 | Liver fat percentage of liver segment 8 as measured by MRI Proton Density Fat Fraction (MR PDFF) at baseline and at week 12 (Visit 8). Delineation by a central radiologist of Liver Segment 8 in the slice with the largest Liver Segment 8 cross-section. | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 8 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | percentage fat | Baseline and Week 12 (Visit 8) |
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| Secondary | Percent Change From Baseline in Mean MRPDFF of Liver Segment 8 | Percent change from baseline in MRPDFF of liver segment 8 at baseline and at week 12 (Visit 8) | Intent-to-Treat. Placebo population: One subject's baseline Liver Segment 8 radius was missing. This patient did have their Visit 8 MRI, however since there was baseline data missing, the change from baseline measurement cannot be calculated. A second patient did not have their Week 12 MRI acquired. ORMD-0801:One subject did not have a Visit 8 MRI (discontinued study due to Withdrew Consent). A second subject did not have a Visit 8 MRI (discontinued study due to Adverse Event) | Posted | Mean | Standard Deviation | percentage change in MRPDFF | Baseline and Week 12 (Visit 8) |
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| Secondary | Liver Steatosis | Liver steatosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M) | Safety Population | Posted | Median | Inter-Quartile Range | dB/M | Baseline and Week 12 (Visit 8) |
|
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| Secondary | Change in Liver Steatosis From Baseline | Change in Liver steatosis from baseline measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M) | Safety Population. One subject did not have a Visit 8 Fibroscan (discontinued study due to Withdrew Consent) A second subject did not have a Visit 8 Fibroscan (discontinued study due to Adverse Event) | Posted | Median | Inter-Quartile Range | dB/M | Baseline and Week 12 (Visit 8) |
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| Secondary | Liver Fibrosis | Liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa). | Safety Population. One subject did not have a Visit 8 Fibroscan (discontinued study due to Withdrew Consent) A second subject did not have a Visit 8 Fibroscan (discontinued study due to Adverse Event) | Posted | Median | Inter-Quartile Range | kPa (kilo Pascals) | Baseline and Week 12 (Visit 8) |
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| Secondary | Change From Baseline of Liver Fibrosis | The change from baseline in liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa). | Safety Population. One subject did not have a Visit 8 Fibroscan (discontinued study due to Withdrew Consent) A second subject did not have a Visit 8 Fibroscan (discontinued study due to Adverse Event) | Posted | Median | Inter-Quartile Range | kPa (kilo Pascals) | Baseline and Week 12 (Visit 8) |
|
|
Placebo Run-In (Week -2) through End-of-Study (Week 16); total of 18 weeks.
NCI CTCAE v. 4.03
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Fish oil Placebo: Matching Placebo | 0 | 11 | 1 | 11 | 4 | 11 |
| EG001 | ORMD-0801 (Insulin) Capsule 8 mg BD | ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral ORMD-0801 (Insulin) capsule 8 mg BD: 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening. | 0 | 21 | 1 | 21 | 7 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointenstinal hemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Addominal Distention | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | COVID-19 infection. |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Oramed, Ltd. | +97225660001 | miriam@oramed.com |
| Feb 27, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583837 | ORMD-0801 |
| D007328 | Insulin |
| D002214 | Capsules |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009821 | Oils |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Surgically Sterilized |
|
| At least 24 months Post-Menopausal |
|
| Not Applicable |
|
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