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NCT04754334 · ClinicalTrials.gov registry record · Phase 3
A 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
- 346
- Enrollment target
NCT04754334: Clinical Trial Phase 3 study, sponsored by Oramed.
NCT04754334 is a Phase 3 study that was terminated before completion, run by Oramed. The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04754334, a Phase 3 study, was terminated before completion, sponsored by Oramed.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.
Primary Outcome
mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups. Randomization will occur at Visit 1 (Week 0),
Interventions
- OTHER Placebo
- DRUG ORMD-0801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2023-01-13 |
| Phase | Phase 3 |
Why NCT04754334 stopped before completion
NCT04754334 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04754334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04754334 about?
NCT04754334 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus". This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and ...
What is the current status of trial NCT04754334?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2021-03-16. Estimated completion is 2023-01-13.
What interventions are being tested in trial NCT04754334?
The interventions under investigation include: Placebo (OTHER), ORMD-0801 (DRUG).
Who is sponsoring clinical trial NCT04754334?
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 NCT04754334's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 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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