Trial · NCT04618744
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
NCT04618744, Phase 2, Completed, Oramed, Ltd.; results first posted 2024-08-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT04618744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04618744
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT04618744
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Oramed, Ltd.
- Conditions
- Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
- Interventions
- ORMD-0801 (Insulin) capsule 8 mg BD, Placebo
- First posted
- 2020-11-06
- Last updated
- 2024-08-07
- Results first posted
- 2024-08-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-Emergent Adverse Events | Screening through Week 16 | 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. |
| Secondary | Median MRPDFF at Baseline and Week 12 of Whole Liver | Baseline and Week 12 (Visit 8) | 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. |
| Secondary | Percent Change From Baseline of Median MRPDFF of Whole Liver | Baseline and Week 12 (Visit 8) | The percent change in MR PDFF from baseline to Week 12 of Whole Liver |
| Secondary | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Baseline and Week 12 | 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. |
| Secondary | Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Screening and Week 12 (Visit 8) | 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 |
| Secondary | Median Magnetic Resonance Proton Density Fat Fraction (MR PDFF) of Liver Segment 3 | Baseline and Week 12 (Visit 8) | 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. |
| Secondary | Percent Change From Baseline of Median MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Percent Change from Baseline Median MRPDFF of Liver Segment measured at baseline and Week 12 (Visit 8) |
| Secondary | Mean MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Mean MRPDFF of Liver Segment measured at baseline and Week 12 |
| Secondary | Percent Change of Mean MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Percent change from baseline of mean MR PDFF measurement of liver segment 3 at baseline and week 12 |
| Secondary | Median MR PDFF of Liver Segment 6 | Screening and Week 12 (Visit 8) | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment-Emergent Adverse Events | Screening through Week 16 | Safety Population | Adverse Events | NUMBER |
| SECONDARY | Median MRPDFF at Baseline and Week 12 of Whole Liver | Baseline and Week 12 (Visit 8) | 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) | Percent fat (MRPDFF) | MEDIAN |
| SECONDARY | Percent Change From Baseline of Median MRPDFF of Whole Liver | Baseline and Week 12 (Visit 8) | 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) | percent change | MEDIAN |
| SECONDARY | Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Baseline and Week 12 | 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) | percentage of fat | MEAN |
| SECONDARY | Percent Change From Baseline in Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Screening and Week 12 (Visit 8) | 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) | Percentage of change in MRPDFF | MEAN |
| SECONDARY | Median Magnetic Resonance Proton Density Fat Fraction (MR PDFF) of Liver Segment 3 | Baseline and Week 12 (Visit 8) | 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) | percentage fat | MEDIAN |
| SECONDARY | Percent Change From Baseline of Median MRPDFF of Liver Segment 3 | 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) | percentage change | MEDIAN |
| SECONDARY | Mean MRPDFF of Liver Segment 3 | Baseline and Week 12 (Visit 8) | Intent to Treat | percentage fat | MEAN |
| SECONDARY | Percent Change of Mean MRPDFF of Liver Segment 3 | 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) | percentage of Change in MR PDFF | MEAN |
| SECONDARY | Median MR PDFF of Liver Segment 6 | Screening and 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) | percentage of liver fat | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment-Emergent Adverse Events | Placebo | 0 | Adverse Events | ||
| Number of Treatment-Emergent Adverse Events | ORMD-0801 (Insulin) Capsule 8 mg BD | 2 | Adverse Events | ||
| Median MRPDFF at Baseline and Week 12 of Whole Liver | Placebo | Median MRPDFF at Baseline | 24.350 | Full Range 9.80 to 31.90 | Percent fat (MRPDFF) |
| Median MRPDFF at Baseline and Week 12 of Whole Liver | ORMD-0801 (Insulin) Capsule 8 mg BD | Median MRPDFF at Baseline | 15.340 | Full Range 5.34 to 27.20 | Percent fat (MRPDFF) |
| Median MRPDFF at Baseline and Week 12 of Whole Liver | Placebo | Median MRPDFF (percentage fat) at Week 12 | 17.300 | Full Range 3.66 to 29.50 | Percent fat (MRPDFF) |
| Median MRPDFF at Baseline and Week 12 of Whole Liver | ORMD-0801 (Insulin) Capsule 8 mg BD | Median MRPDFF (percentage fat) at Week 12 | 13.300 | Full Range 3.33 to 26.80 | Percent fat (MRPDFF) |
| Percent Change From Baseline of Median MRPDFF of Whole Liver | Placebo | -1.103 | Full Range -28.97 to 16.33 | percent change | |
| Percent Change From Baseline of Median MRPDFF of Whole Liver | ORMD-0801 (Insulin) Capsule 8 mg BD | -7.105 | Full Range -65.78 to 59.18 | percent change | |
| Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | Placebo | Mean MRPDFF of Whole Liver at Baseline | 21.558 | Standard Deviation 8.2072 | percentage of fat |
| Mean Magnetic Resonance Proton Density Fat Fraction (MRPDFF) of Whole Liver | ORMD-0801 (Insulin) Capsule 8 mg BD | Mean MRPDFF of Whole Liver at Baseline | 15.683 | Standard Deviation 6.1605 | percentage of fat |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | STARTED | ORMD-0801 (Insulin) Capsule 8 mg BD | 21 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | COMPLETED | ORMD-0801 (Insulin) Capsule 8 mg BD | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | ORMD-0801 (Insulin) Capsule 8 mg BD | 2 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial Fibrillation | Cardiac disorders | Placebo | 1 | 11 | 1 |
| other | Atrial Fibrillation | Cardiac disorders | ORMD-0801 (Insulin) Capsule 8 mg BD | 1 | 21 | |
| other | Atrial Flutter | Cardiac disorders | Placebo | 1 | 11 | 1 |
| other | Atrial Flutter | Cardiac disorders | ORMD-0801 (Insulin) Capsule 8 mg BD | 0 | 21 | 0 |
| other | Addominal Distention | Gastrointestinal disorders | Placebo | 0 | 11 | 0 |
| other | Addominal Distention | Gastrointestinal disorders | ORMD-0801 (Insulin) Capsule 8 mg BD | 5 | 21 | 5 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 11 | 0 |
| other | Nausea | Gastrointestinal disorders | ORMD-0801 (Insulin) Capsule 8 mg BD | 2 | 21 | 2 |
| other | COVID-19 | Infections and infestations | Placebo | 1 | 11 | 1 |
| other | COVID-19 | Infections and infestations | ORMD-0801 (Insulin) Capsule 8 mg BD | 0 | 21 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, all-cause mortality | ORMD-0801 (Insulin) Capsule 8 mg BD | 0 | 21 |
| Total, other adverse events | Placebo | 4 | 11 |
| Total, other adverse events | ORMD-0801 (Insulin) Capsule 8 mg BD | 7 | 21 |
| Total, serious adverse events | Placebo | 1 | 11 |
| Total, serious adverse events | ORMD-0801 (Insulin) Capsule 8 mg BD | 1 | 21 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ORMD-0801 (Insulin) Capsule 8 mg BD vs Placebo: deaths from any cause | Trial comparisons |
| ORMD-0801 (Insulin) Capsule 8 mg BD vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04618744
GET https://conductscience.org/api/trials/v1/NCT04618744/registered?page=2