A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
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|ClinicalTrials.gov Identifier: NCT02653300|
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Steatohepatitis (NASH) Type2 Diabetes Mellitus||Biological: Oral Insulin||Phase 2|
This exploratory study will first enroll 10 patients with NASH and type 2 DM, to evaluate the safety of oral insulin and to measure the change in liver fat content.
At the completion of their 4-week follow-up period, results will be presented to the Helsinki Committee. Following approval, an additional 20 patients will be enrolled. The size of the study population was determined by the investigator (with literature review) to be sufficient to show trends of reducing liver fat content by analysis of MRI PDFF (MRI-Proton Density Fat Fraction) images, the FibroMax™ Test and Fibroscan® including Controlled Attenuation Parameter (CAP™). CAP™ is a measure of the ultrasound attenuation to quantify steatosis in the liver.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Oral Insulin
Biological: Oral Insulin
all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
- Change in MRI-Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: Two timepoints: Baseline (week 0) and Week 12 ]Change in MRI-Proton Density Fat Fraction and percentage change from baseline to week 12
- Change in Transient Elastography Measurement (Fibroscan) [ Time Frame: Two timepoints: Baseline (week 0) and Week 12 ]Change in the transient elasticity, measured in kPA (kilo Pascal), and percent change from baseline.
- Change in Fibrosis score (FibroMax) [ Time Frame: Two timepoints: Baseline (week 0) and Week 12 ]Change in the fibrosis score (severity scale of liver fibrosis) and percentage change from baseline to week 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653300
|Contact: Rifaat Safadi, M.D.||972 (0) 2 email@example.com|
|Contact: Miriam Kidron, Ph.D.||972-(0) firstname.lastname@example.org|
|Hadassah Medical Center||Recruiting|
|Contact: Rifat Safadi, M. D. 972 (0) 2 6777337 email@example.com|
|Contact: Rifat Safadi, M.D. 972 (0)2 6777337 firstname.lastname@example.org|
|Principal Investigator:||Rifaat Safadi, M.D.||Hadassah Medical Center|