| Trial ID: | L0406 |
| Source ID: | NCT04618744
|
| Associated Drug: |
Insulin
|
| Title: |
A Double-Blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Diabetes Mellitus, Type 2;NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: ORMD-0801 (Insulin) capsule 8 mg BD;Other: Placebo
|
| Outcome Measures: |
Number of treatment-related adverse eventsPercent change in liver fat content
|
| Sponsor/Collaborators: |
Oramed, Ltd.
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
36
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
01/11/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
21 December 2021
|
| Locations: |
United States;Israel;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04618744
|
