NCT04618744

A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Oramed, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.

Detailed description

This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM. The study will consist of a Screening Phase, Placebo Run-in Phase, Treatment Phase and an End-of-Study Phase. Approximately 36 subjects will be randomized in a 2:1 ratio to receive either 8 mg ORMD-0801, 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) or matching placebo.

Conditions

• Diabetes Mellitus, Type 2
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	ORMD-0801 (Insulin) capsule 8 mg BD	8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening.
OTHER	Placebo	Matching Placebo

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-06-27
• Completion: 2022-06-27
• First posted: 2020-11-06
• Last updated: 2024-08-07
• Results posted: 2024-08-07

Locations

3 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study