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NCT04606576 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Oramed.
- Terminated
- Registry status
- Phase 3
- Development phase
- 710
- Enrollment target
NCT04606576: Clinical Trial Phase 3 study, sponsored by Oramed.
NCT04606576 is a Phase 3 study that was terminated before completion, run by Oramed. The registered enrollment target is 710 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606576, a Phase 3 study, was terminated before completion, sponsored by Oramed.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 710 participants
- Enrollment target
Study Summary
In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.
Primary Outcome
The mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups.
Interventions
- OTHER Placebo
- DRUG ORMD-0801 QD
- DRUG ORMD-0801 BD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2023-01-13 |
| Phase | Phase 3 |
Why NCT04606576 stopped before completion
NCT04606576 is an interventional study that assigns participants to a tested intervention. The registered 710 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04606576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04606576 about?
NCT04606576 is a clinical study titled "Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus". In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treat...
What is the current status of trial NCT04606576?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 710 participants. The study started on 2020-12-15. Estimated completion is 2023-01-13.
What interventions are being tested in trial NCT04606576?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 QD (DRUG), ORMD-0801 BD (DRUG).
Who is sponsoring clinical trial NCT04606576?
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 NCT04606576's enrollment target sits among peer trials
710 502nd of 2000 higher than 1,496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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