A Phase 2 interventional study of ORMD-0801 (Insulin) capsule 8 mg BD and Placebo in Diabetes Mellitus, Type 2 and NASH - Nonalcoholic Steatohepatitis, sponsored by Oramed, Ltd.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Oramed, Ltd. · Phase 2, Interventional, and Treatment
Among 222 studies in Diabetes Mellitus, Type 2 with a site in Israel — 9 open to participants now, 15 under way, 6 of them phase 3. Diabetes Mellitus, Type 2 · Israel.
Among the 222 studies in Diabetes Mellitus, Type 2 with a site in Israel, this one is the 174th largest by enrollment of the 196 interventional ones, is one of 10 that started in 2020, is one of 19 in phase 2, and was the 196th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →9 of the 222 studies in Diabetes Mellitus, Type 2 with a site in Israel are open now, in 12 countries. Each count lists the studies.
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →222 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 10 started in 2020.
Median enrollment 337 across the 196 interventional studies, 1,118 across the 24 observational. Of the 173 that completed or were terminated, 106 (61%) have results posted.
160 of 222 have an industry lead sponsor. The 10 most frequent:
Oramed, Ltd. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Oramed, Ltd. has 9 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
3 of the studies in Diabetes Mellitus, Type 2 with a site in Israel that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT06497595Sheba Medical CenterLifestyle Intervention to Reduce the Risk of Sarcopenia in Adults With Diabetes & Obesity Treated With Semaglutide | 2027-09-30 |
Among the 222 studies in Diabetes Mellitus, Type 2 with a site in Israel, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects meeting criteria for 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fish oil
Other: Placebo
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
Drug: 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.
Also known as: Oral Insulin
Matching Placebo
Also known as: Fish oil
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.
Time frame: Screening through Week 16
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.
Time frame: Baseline and Week 12 (Visit 8)
Percent Change From Baseline of Median MRPDFF of Whole Liver
The percent change in MR PDFF from baseline to Week 12 of Whole Liver
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: Baseline and Week 12 (Visit 8)
Mean MRPDFF of Liver Segment 3
Mean MRPDFF of Liver Segment measured at baseline and Week 12
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: Baseline and Week 12 (Visit 8)
| Milestone | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Started | 11 | 21 |
| Completed | 11 | 19 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Adverse Events | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Number of Treatment-Emergent Adverse Events | 0 | 2 |
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.
| Percent fat (MRPDFF) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Median MRPDFF at Baseline | 24.350 (9.80 to 31.90) | 15.340 (5.34 to 27.20) |
| Median MRPDFF (percentage fat) at Week 12 | 17.300 (3.66 to 29.50) | 13.300 (3.33 to 26.80) |
The percent change in MR PDFF from baseline to Week 12 of Whole Liver
| percent change | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change From Baseline of Median MRPDFF of Whole Liver | -1.103 (-28.97 to 16.33) | -7.105 (-65.78 to 59.18) |
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.
| percentage of fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Mean MRPDFF of Whole Liver at Baseline | 21.558 ± 8.2072 | 15.683 ± 6.1605 |
| Mean MR PDFF of Whole Liver at Week 12 | 17.414 ± 8.6331 | 14.274 ± 6.8032 |
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
| Percentage of change in MRPDFF | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | -6.526 ± 15.3158 | -7.489 ± 27.3972 |
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.
| percentage fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Median MRPDFF Liver Segment 3 Baseline | 21.10 (6.97 to 33.50) | 13.900 (5.34 to 26.90) |
| Median MRPDFF Liver Segment 3 Week 12 | 15.150 (3.11 to 28.70) | 11.900 (3.28 to 26.43) |
Percent Change from Baseline Median MRPDFF of Liver Segment measured at baseline and Week 12 (Visit 8)
| percentage change | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change From Baseline of Median MRPDFF of Liver Segment 3 | 0.000 (-26.97 to 26.40) | -6.424 (-66.67 to 10.19) |
Mean MRPDFF of Liver Segment measured at baseline and Week 12
| percentage fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| MRPDFF of Liver Segment 3 at baseline | 20.617 ± 9.1032 | 14.560 ± 5.3974 |
| MR PDFF of Liver Segment 3 at Week 12 | 16.610 ± 9.2736 | 13.119 ± 6.2239 |
Percent change from baseline of mean MR PDFF measurement of liver segment 3 at baseline and week 12
| percentage of Change in MR PDFF | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change of Mean MRPDFF of Liver Segment 3 | 0.105 ± 17.2630 | -10.763 ± 20.9231 |
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.
| percentage of liver fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Median MRPDFF of Liver Segment 6 Baseline | 22.900 (8.76 to 37.00) | 15.420 (4.81 to 30.00) |
| Median MRPDFF of Liver Segment 6 Week 12 | 15.400 (3.28 to 27.40) | 12.600 (5.19 to 27.13) |
Percent Change from Baseline of Median Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12
| percent change | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change From Baseline of Median MR PDFF of Liver Segment 6 | -4.965 (-37.19 to 15.01) | -6.488 (-41.49 to 54.63) |
Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8)
| percentage liver fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Mean MRPDFF of liver segment 6 at Baseline | 22.174 ± 8.9629 | 15.828 ± 7.3523 |
| Mean MRPDFF of Liver segment 6 at Week 12 | 16.226 ± 8.4452 | 14.009 ± 7.1855 |
Percent Change from Baseline Mean Magnetic Resonance Proton Density Fat Fraction of Liver Segment 6 measured at baseline and at week 12 (Visit 8)
| percent change | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change From Baseline of Mean MR PDFF of Liver Segment 6 | -9.891 ± 15.3865 | -9.310 ± 21.7602 |
Median MRPDFF of Liver Segment 8 measured at baseline and Week 12 (Visit 8)
| percentage liver fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Median MRPDFF of Liver Segment 8 at baseline | 25.100 (8.06 to 31.20) | 15.600 (6.63 to 28.20) |
| Median MR PDFF of Liver Segment 8 at Week 12 | 18.200 (3.66 to 27.90) | 13.500 (3.27 to 28.03) |
Percent change from baseline in median MRPDFF of Liver segment 8 measured at baseline and week 12 (Visit 8).
| percent change of the median MRPDFF | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change in Median MRPDFF of Liver Segment 8 | -6.376 (-35.71 to 12.54) | -5.419 (-65.18 to 32.75) |
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.
| percentage fat | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Mean MRPDFF of liver segment 8 at Baseline | 22.565 ± 7.8978 | 16.071 ± 6.3147 |
| Mean MRPDFF of Liver segment 8 at Week 12 | 17.451 ± 2.8338 | 14.817 ± 7.1945 |
Percent change from baseline in MRPDFF of liver segment 8 at baseline and at week 12 (Visit 8)
| percentage change in MRPDFF | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Percent Change From Baseline in Mean MRPDFF of Liver Segment 8 | 17.451 ± 8.6343 | 14.817 ± 7.1945 |
Liver steatosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of decibels per meter (dB/M)
| dB/M | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Median Liver Steatosis Baseline | 335 (276 to 345) | 329 (299 to 357) |
| Median Liver Steatosis Week 12 | 345.0 (320.0 to 360.0) | 329.0 (279.0 to 351.0) |
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)
| dB/M | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Change in Liver Steatosis From Baseline | 13.0 (0.0 to 38.0) | -16.0 (-38.0 to 22) |
Liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa).
| kPa (kilo Pascals) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Median Liver Fibrosis Baseline | 8.4 (6.4 to 9.0) | 8.6 (6.7 to 9.2) |
| Median Liver Fibrosis Week 12 | 7.4 (6.5 to 8.7) | 7.4 (6.4 to 9.7) |
The change from baseline in liver fibrosis measured by FibroScan® at baseline and at week 12 (Visit 8), in units of kilo Pascals (kPa).
| kPa (kilo Pascals) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Change From Baseline of Liver Fibrosis | 0.3 (-2.6 to 2.3) | -0.8 (-2.5 to 3.8) |
Collected over Placebo Run-In (Week -2) through End-of-Study (Week 16); total of 18 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/11 (0%) | 1/11 (9.1%) | 4/11 (36.4%) |
| ORMD-0801 (Insulin) Capsule 8 mg BD | 0/21 (0%) | 1/21 (4.8%) | 7/21 (33.3%) |
| Event | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Atrial fibrillationCardiac disorders | 1/11 | 0/21 |
| Gastrointenstinal hemorrhageGastrointestinal disorders | 0/11 | 1/21 |
| Event | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD |
|---|---|---|
| Addominal DistentionGastrointestinal disorders | 0/11 | 5/21 |
| NauseaGastrointestinal disorders | 0/11 | 2/21 |
| Atrial FibrillationCardiac disorders | 1/11 | 1/21 |
| Atrial FlutterCardiac disorders | 1/11 | 0/21 |
| COVID-19Infections and infestations | 1/11 | 0/21 |
| HyperglycemiaMetabolism and nutrition disorders | 1/11 | 0/21 |
| HypokalaemiaMetabolism and nutrition disorders | 0/11 | 1/21 |
Intent to Treat
| Age, Continuous(Years) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| Mean | 56.73 ± 10.355 | 58.67 ± 7.565 | 58.00 ± 8.508 |
| Sex: Female, Male(Participants) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 6 | 14 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 11 | 18 |
| Not Hispanic or Latino | 4 | 10 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 10 | 19 | 29 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body Mass Index (BMI)(Kg/m^2) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| Mean | 32.109 ± 4.5496 | 33.567 ± 5.2981 | 33.066 ± 5.0281 |
| Childbearing Status(Participants) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| Of Childbearing Potential | 0 | 0 | 0 |
| Surgically Sterilized | 2 | 4 | 6 |
| At least 24 months Post-Menopausal | 3 | 3 | 6 |
| Not Applicable | 6 | 14 | 20 |
| Median Magnetic Resonance Proton Fat Fraction (MRPDFF)(percent liver fat) | Placebo | ORMD-0801 (Insulin) Capsule 8 mg BD | Total |
|---|---|---|---|
| Median | 21.100 (6.97 to 33.50) | 13.900 (5.34 to 26.90) | 14.250 (5.34 to 33.50) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in Jun 2022, 19 months.
Results were first posted in Aug 2024, 2 years 1 month after primary completion.
Of 194 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 19 months is above that.
Counting every sponsor, half of 293 studies reached it within 15 months; a quarter within 11 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ORMD-0801
Oramed, Ltd.