Trial Outcomes & Findings for A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) (NCT NCT04616014)

Last Updated: 2024-03-29

Results Overview

The safety of Oral Insulin will be measured by the number of treatment-related adverse events according to CTCAE version 5.0 A biostatistician reviewed the study data and determined that it is of poor quality and cannot be appropriately analyzed. Conclusions about this study cannot be made based on the study data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Week -6 through Week 12 inclusive

Results posted on

2024-03-29

Participant Flow

Patients were enrolled from three medical centers in Belgium. Patient Screening start: 05 January 2021 Last Patient Last Visit: 01 July 2022

Recruitment of this study was hampered due to COVID-19 restrictions.

Participant milestones

Participant milestones
Measure	ORMD-0801 QD 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ORMD-0801 QD n=7 Participants 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
Age, Continuous	59.1428 years STANDARD_DEVIATION 7.5372 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fibrosis Score	7.3428 kPa STANDARD_DEVIATION 1.0014 • n=5 Participants

PRIMARY outcome

Timeframe: Week -6 through Week 12 inclusive

Outcome measures

Outcome measures
Measure	ORMD-0801 QD n=7 Participants 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
Number of Participants With Treatment-related Adverse Events.	3 Participants

SECONDARY outcome

Timeframe: Week -6 (screening) and Week 12

Population: Intent-to-treat

The change in liver fat content measured by MRI-Proton Density Fat Fraction from week -6 to week 12 MR PDFF is expressed as a fat percentage in the liver. Change in MR PDFF = MR PDFF (week 12) - MR PDFF( Screening) A biostatistician reviewed the study data and determined that it is of poor quality and cannot be appropriately analyzed. Conclusions about this study cannot be made based on the study data.

Outcome measures

Outcome measures
Measure	ORMD-0801 QD n=7 Participants 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
Change From Screening in Liver Fat Content as Measured by MRI Proton Density Fat Fraction (MR PDFF) Mean Screening MR PDFF	19.233 percentage of fat Standard Deviation 7.956
Change From Screening in Liver Fat Content as Measured by MRI Proton Density Fat Fraction (MR PDFF) Mean Week 12 MR PDFF	19.560 percentage of fat Standard Deviation 10.026
Change From Screening in Liver Fat Content as Measured by MRI Proton Density Fat Fraction (MR PDFF) Change from Screening in MR PDFF	0.3271 percentage of fat Standard Deviation 9.0502

SECONDARY outcome

Timeframe: Week -6 (Screening) and Week 12

Change from screening in Mean Transient Elasticity (Fibrosis) measured in kPA (kilo Pascal). A biostatistician reviewed the study data and determined that it is of poor quality and cannot be appropriately analyzed. Conclusions about this study cannot be made based on the study data.

Outcome measures

Outcome measures
Measure	ORMD-0801 QD n=7 Participants 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
Change From Screening in Liver Fibrosis (Elasticity) Week -6 Fibroscan Elasticity	7.714 kiloPascals (kPa) Standard Deviation 1.721
Change From Screening in Liver Fibrosis (Elasticity) Week 12 Fibroscan Fibrosis (Elasticity)	7.057 kiloPascals (kPa) Standard Deviation 1.651
Change From Screening in Liver Fibrosis (Elasticity) Mean Change between week -6 and week 12 Fibroscan Fibrosis (Elasticity)	-0.6571 kiloPascals (kPa) Standard Deviation 1.7696

SECONDARY outcome

Timeframe: Week -6 and Week 12

Change in liver steatosis as measured by FibroScan Controlled Attenuation Parameter (CAP) in units of dB/meter. Mean fibrosis score (severity scale of liver fibrosis) measured at screening (week -6) and week 12. Fibrosis Score CAP measures the 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. A biostatistician reviewed the study data and determined that it is of poor quality and cannot be properly analyzed. Conclusions about this study cannot be made based on the study data.

Outcome measures

Outcome measures
Measure	ORMD-0801 QD n=7 Participants 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
Change From Screening in Liver Steatosis Screening Fibroscan CAP (Steatosis)	317.714 dB/M Standard Deviation 38.604
Change From Screening in Liver Steatosis Week 12 Fibroscan CAP (steatosis)	328.429 dB/M Standard Deviation 34.457
Change From Screening in Liver Steatosis Change from Screening in Fibroscan CAP	10.7129 dB/M Standard Deviation 36.5896

Adverse Events

ORMD-0801 QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ORMD-0801 QD n=7 participants at risk 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each ORMD-0801 QD: 16 mg, QD, two capsules, 8 mg each.
General disorders Bronchitis	14.3% 1/7 • Number of events 1 • Week -6 to Week 12 inclusive. AE's will be coded using the most current version of MedDRA. The severity of AEs will be graded according to NCI CTCAE version 4.03. AE's will be regarded as "pretreatment" if they occur during the Placebo run-in period. TEAEs are any AE that starts or increases in severity after the first dose of IMP at Visit 3.
General disorders Pruritus	14.3% 1/7 • Number of events 1 • Week -6 to Week 12 inclusive. AE's will be coded using the most current version of MedDRA. The severity of AEs will be graded according to NCI CTCAE version 4.03. AE's will be regarded as "pretreatment" if they occur during the Placebo run-in period. TEAEs are any AE that starts or increases in severity after the first dose of IMP at Visit 3.
Gastrointestinal disorders Diarrhia	57.1% 4/7 • Number of events 5 • Week -6 to Week 12 inclusive. AE's will be coded using the most current version of MedDRA. The severity of AEs will be graded according to NCI CTCAE version 4.03. AE's will be regarded as "pretreatment" if they occur during the Placebo run-in period. TEAEs are any AE that starts or increases in severity after the first dose of IMP at Visit 3.
Gastrointestinal disorders STEATORRHEA	28.6% 2/7 • Number of events 2 • Week -6 to Week 12 inclusive. AE's will be coded using the most current version of MedDRA. The severity of AEs will be graded according to NCI CTCAE version 4.03. AE's will be regarded as "pretreatment" if they occur during the Placebo run-in period. TEAEs are any AE that starts or increases in severity after the first dose of IMP at Visit 3.

Additional Information

Chief Scientific Officer

Oramed, Ltd.

Phone: 972-2-566-0001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60