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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04616014
Other study ID # ORA-D-N01B
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date September 15, 2022

Study information

Verified date March 2024
Source Oramed, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)


Description:

An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)


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Study Design


Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
ORMD-0801 QD
16 mg, QD, two capsules, 8 mg each.

Locations

Country Name City State
Belgium Universitaire Ziekenhuis Gent Gent

Sponsors (1)

Lead Sponsor Collaborator
Oramed, Ltd.

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Campos GM, Bambha K, Vittinghoff E, Rabl C, Posselt AM, Ciovica R, Tiwari U, Ferrel L, Pabst M, Bass NM, Merriman RB. A clinical scoring system for predicting nonalcoholic steatohepatitis in morbidly obese patients. Hepatology. 2008 Jun;47(6):1916-23. doi: 10.1002/hep.22241. — View Citation

Ratziu V, Bellentani S, Cortez-Pinto H, Day C, Marchesini G. A position statement on NAFLD/NASH based on the EASL 2009 special conference. J Hepatol. 2010 Aug;53(2):372-84. doi: 10.1016/j.jhep.2010.04.008. Epub 2010 May 7. No abstract available. — View Citation

Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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
Secondary 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
Secondary 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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