At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Oral Insulinbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Pilot Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential of Oral Insulin to Reduce Liver Fat Content and Fibrosis in Patients With Nonalcolholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating Oral Insulin for Non-Alcoholic Steatohepatitis (NASH) and Type2 Diabetes Mellitus. Completed, enrolled 10 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
CollaboratorsHadassah Medical Organization
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartSep 2018
Primary CompletionMar 2020
Study CompletionApr 2020
TodayJul 2026
First PostedJan 12, 2016
Enrollment StartSep 20, 2018
Primary CompletionMar 1, 2020
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.5 years ago
Interventions
Oral Insulinbiological
all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.