At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
ORMD-0801 (Insulin) capsule 8 mg BD +1 moredrug
Likely dose
ORMD-0801 (Insulin) capsule 8 mg BDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 (Insulin) capsule 8 mg BD and Placebo for Diabetes Mellitus, Type 2 and NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 32 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael, United States
CollaboratorsIntegrium
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartNov 2020
Primary CompletionJun 2022
TodayJul 2026
First PostedNov 6, 2020
Enrollment StartNov 24, 2020
Primary CompletionJun 27, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.7 years ago
Interventions
ORMD-0801 (Insulin) capsule 8 mg BDdrug
8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening.
Placeboother
Matching Placebo