A Phase 2 interventional study of Oral Insulin in Non-Alcoholic Steatohepatitis (NASH) and Type2 Diabetes Mellitus, sponsored by Oramed, Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Oramed, Ltd. · Phase 2, Interventional, and Treatment
Among 63 studies in Non-alcoholic Fatty Liver Disease with a site in Israel — 6 open to participants now, 10 under way, 8 of them phase 3. Non-alcoholic Fatty Liver Disease · Israel.
Among the 63 studies in Non-alcoholic Fatty Liver Disease with a site in Israel, this one is the 49th largest by enrollment of the 52 interventional ones, is one of 4 that started in 2018, is one of 20 in phase 2, and was the 29th registered.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →6 of the 63 studies in Non-alcoholic Fatty Liver Disease with a site in Israel are open now, in 12 countries. Each count lists the studies.
Of the 221 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 126 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →63 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2018.
Median enrollment 111 across the 52 interventional studies, 70 across the 6 observational. Of the 36 that completed or were terminated, 18 (50%) have results posted.
34 of 63 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 3 studies filed under Non-alcoholic Fatty Liver Disease — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 63 studies in Non-alcoholic Fatty Liver Disease with a site in Israel, from their registry updates:
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo run-in, treatment phase and end-of-study phase.
This exploratory study will first enroll 10 patients with NASH and type 2 DM, to evaluate the safety of oral insulin and to measure the change in liver fat content.
At the completion of their 4-week follow-up period, results will be presented to the Helsinki Committee. Following approval, an additional 20 patients will be enrolled. The size of the study population was determined by the investigator (with literature review) to be sufficient to show trends of reducing liver fat content by analysis of MRI PDFF (MRI-Proton Density Fat Fraction) images, the FibroMax™ Test and Fibroscan® including Controlled Attenuation Parameter (CAP™). CAP™ is a measure of the ultrasound attenuation to quantify steatosis in the liver.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
treatment
Biological: Oral Insulin
all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Change in MRI-Proton Density Fat Fraction (MRI-PDFF)
Absolute Change in MRI-Proton Density Fat Fraction (expressed as percent fat in the liver) from baseline to week 12
Time frame: Two timepoints: Baseline (week 0) and Week 12
Mean Transient Elastography Measurement (Fibroscan)
Mean Transient elasticity, measured in kPA (kilo Pascal),
Time frame: Two timepoints: Baseline (week 0) and Week 12
Mean Fibrosis Score CAP™ (FibroMax)
Mean fibrosis score (severity scale of liver fibrosis) measured at baseline and week 12. Fibrosis Score CAP measures the amount of steatosis (fatty change) in the liver. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m with higher values indicating more fatty change
Time frame: Two timepoints: Baseline (week 0) and Week 12
| Milestone | Oral Insulin |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Absolute Change in MRI-Proton Density Fat Fraction (expressed as percent fat in the liver) from baseline to week 12
| percentage fat in the liver | Oral Insulin |
|---|---|
| MRPDFF (%) at baseline | 21.3 ± 7.2 |
| MR PDFF (%) at Week 12 | 14.4 ± 6.3 |
| Absolute Mean Change in MR PDFF (%) from Baseline | -6.9 ± 6.8 |
Mean Transient elasticity, measured in kPA (kilo Pascal),
| kPa | Oral Insulin |
|---|---|
| Baseline | 8.6 ± 1.5 |
| Week 12 | 7.4 ± 2.5 |
Mean fibrosis score (severity scale of liver fibrosis) measured at baseline and week 12. Fibrosis Score CAP measures the amount of steatosis (fatty change) in the liver. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m with higher values indicating more fatty change
| dB/M | Oral Insulin |
|---|---|
| Mean Fibrosis Score at Baseline | 338.5 ± 15.6 |
| Mean Fibrosis Score at week 12 | 315.5 ± 39.6 |
Collected over twelve weeks (Baseline to 12 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Insulin | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Oral Insulin |
|---|---|
| Mean | 51.8 ± 11.6 |
| Sex: Female, Male(Participants) | Oral Insulin |
|---|---|
| Female | 3 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Oral Insulin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Oral Insulin |
|---|---|
| Israel | 10 |
| BMI(Kg/M^2) | Oral Insulin |
|---|---|
| Mean | 32.08 ± 5.2 |
Plan to share: No
Ran from Sep 2018 to primary completion in Mar 2020, 17 months.
Results were first posted in Sep 2021, 1 year 6 months after primary completion.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 17 months is below that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin
Non-alcoholic Fatty Liver Disease →
Oramed, Ltd.