Trial Outcomes & Findings for A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH) (NCT NCT02653300)

NCT ID: NCT02653300

Last Updated: 2024-03-13

Results Overview

Absolute Change in MRI-Proton Density Fat Fraction (expressed as percent fat in the liver) from baseline to week 12

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Two timepoints: Baseline (week 0) and Week 12

Results posted on

2024-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Insulin treatment Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Insulin treatment Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Insulin n=10 Participants treatment Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Age, Continuous	51.8 years STANDARD_DEVIATION 11.6 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Israel	10 participants n=93 Participants
BMI	32.08 Kg/M^2 STANDARD_DEVIATION 5.2 • n=93 Participants

PRIMARY outcome

Timeframe: Two timepoints: Baseline (week 0) and Week 12

Absolute Change in MRI-Proton Density Fat Fraction (expressed as percent fat in the liver) from baseline to week 12

Outcome measures

Outcome measures
Measure	Oral Insulin n=8 Participants treatment 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) MRPDFF (%) at baseline	21.3 percentage fat in the liver Standard Deviation 7.2
Change in MRI-Proton Density Fat Fraction (MRI-PDFF) MR PDFF (%) at Week 12	14.4 percentage fat in the liver Standard Deviation 6.3
Change in MRI-Proton Density Fat Fraction (MRI-PDFF) Absolute Mean Change in MR PDFF (%) from Baseline	-6.9 percentage fat in the liver Standard Deviation 6.8

SECONDARY outcome

Timeframe: Two timepoints: Baseline (week 0) and Week 12

Mean Transient elasticity, measured in kPA (kilo Pascal),

Outcome measures

Outcome measures
Measure	Oral Insulin n=8 Participants treatment Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Mean Transient Elastography Measurement (Fibroscan) Baseline	8.6 kPa Standard Deviation 1.5
Mean Transient Elastography Measurement (Fibroscan) Week 12	7.4 kPa Standard Deviation 2.5

SECONDARY outcome

Timeframe: Two timepoints: Baseline (week 0) and Week 12

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

Outcome measures

Outcome measures
Measure	Oral Insulin n=8 Participants treatment Oral Insulin: all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Mean Fibrosis Score CAP™ (FibroMax) Mean Fibrosis Score at Baseline	338.5 dB/M Standard Deviation 15.6
Mean Fibrosis Score CAP™ (FibroMax) Mean Fibrosis Score at week 12	315.5 dB/M Standard Deviation 39.6

Adverse Events

Oral Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miriam Kidron, Ph.D.

Oramed Pharmaceuticals

Phone: +972-2-566-0100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60