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Insulin

ORMD-0801 (Insulin) capsule 8 mg BD for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Led By Joel M Neutel, M. D.
Research Sponsored by Oramed, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

Study Summary

This study is evaluating whether a new insulin pill may help treat type 2 diabetes and NASH.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of treatment-related adverse events
Secondary outcome measures
Percent change in liver fat content

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ORMD-0801 (Insulin) capsule 8 mg BDExperimental Treatment1 Intervention
ORMD-0801 (insulin) capsule Dose: 8 mg BD Dosage Regimen: 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) Mode of Administration: Oral
Group II: PlaceboPlacebo Group1 Intervention
Fish oil
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ORMD-0801 (Insulin) capsule 8 mg BD
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Oramed, Ltd.Lead Sponsor
13 Previous Clinical Trials
2,419 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
17 Patients Enrolled for Non-alcoholic Fatty Liver Disease
IntegriumIndustry Sponsor
25 Previous Clinical Trials
5,242 Total Patients Enrolled
Miriam Kidron, Ph.D.Study DirectorOramed, Ltd.
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
HepatologyJournal
The Diagnosis and Management of Non-alcoholic Fatty Liver Disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association
Chalasani, Naga, Zobair Younossi, Joel E. Lavine, Anna Mae Diehl, Elizabeth M. Brunt, Kenneth Cusi, Michael Charlton, and Arun J. Sanyal. 2012. “The Diagnosis and Management of Non-alcoholic Fatty Liver Disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association”. Hepatology. Wiley. doi:10.1002/hep.25762.
clinicaltrials.govStudy
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
2020. "A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04618744.
~7 spots leftby Apr 2025
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