| Trial ID: | L3615 |
| Source ID: | NCT04616014
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| Associated Drug: |
Ormd-0801 Qd
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| Title: |
A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT04616014/results
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| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
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| Interventions: |
DRUG: ORMD-0801 QD
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| Outcome Measures: |
Primary: Number of Participants With Treatment-related Adverse Events., 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., Week -6 through Week 12 inclusive | Secondary: Change From Screening in Liver Fat Content as Measured by MRI Proton Density Fat Fraction (MR PDFF), 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., Week -6 (screening) and Week 12|Change From Screening in Liver Fibrosis (Elasticity), 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., Week -6 (Screening) and Week 12|Change From Screening in Liver Steatosis, 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., Week -6 and Week 12
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| Sponsor/Collaborators: |
Sponsor: Oramed, Ltd.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
7
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2021-03-01
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| Completion Date: |
2022-09-15
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| Results First Posted: |
2024-03-29
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| Last Update Posted: |
2024-03-29
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| Locations: |
Universitaire Ziekenhuis Gent, Gent, 9000, Belgium
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| URL: |
https://clinicaltrials.gov/show/NCT04616014
|
