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

NCT02653300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-13

Study results available
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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.

Conditions

  • Non-Alcoholic Steatohepatitis (NASH)
  • Type2 Diabetes Mellitus

Interventions

BIOLOGICAL

Oral Insulin

all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Oramed, Ltd.

    lead INDUSTRY

Principal Investigators

  • Rifaat Safadi, M.D. · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2020-03-01
Completion
2020-04-01
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653300 on ClinicalTrials.gov