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NCT04618744 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Oramed.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT04618744: Completed Phase 2 study, sponsored by Oramed.
NCT04618744 is a Phase 2 study that has completed, run by Oramed. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04618744, a Phase 2 study, has completed, sponsored by Oramed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
The Number of Treatment-Emergent Adverse Events (TEAE) according to CTCAE version 4.03. A TEAE is an adverse event for which the start date is on or after the date that the treatment began.
Interventions
- OTHER Placebo
- DRUG ORMD-0801 (Insulin) capsule 8 mg BD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2022-06-27 |
| Phase | Phase 2 |
What the finished NCT04618744 record still lists
NCT04618744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04618744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04618744 about?
NCT04618744 is a clinical study titled "A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)". 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.
What is the current status of trial NCT04618744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2020-11-24. Estimated completion is 2022-06-27.
What interventions are being tested in trial NCT04618744?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 (Insulin) capsule 8 mg BD (DRUG).
Who is sponsoring clinical trial NCT04618744?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04618744's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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