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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 is a Phase 3 study that was terminated before completion, run by Oramed. The registered enrollment target is 346 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04754334
The ClinicalTrials.gov registry entry for NCT04754334 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 346 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oramed, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04754334 reports 0 study locations.
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.
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