At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
ORMD-0801 QDdrug
Likely dose
ORMD-0801 QD 16 mgfrom 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.
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)
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 QD for Nonalcoholic Steatohepatitis (NASH). Completed, enrolled 7 participants across 1 site.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Steatohepatitis (NASH)
CountriesBelgium
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartMar 2021
Primary CompletionJul 2022
Study CompletionSep 2022
TodayJul 2026
First PostedNov 4, 2020
Enrollment StartMar 1, 2021
Primary CompletionJul 1, 2022
Study CompletionSep 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.7 years ago
Interventions
ORMD-0801 QDdrug
16 mg, QD, two capsules, 8 mg each.