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NCT06731075 · 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.
- Not yet
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT06731075 is a Phase 3 study that has not yet begun recruiting, run by Oramed. The registered enrollment target is 300 participants.
The verdict
NCT06731075, a Phase 3 study, has not yet begun recruiting, sponsored by Oramed.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.
Interventions
- OTHER Placebo capsule
- DRUG ORMD-0801 8 mg
- DRUG ORMD-0801 16 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-12-15 |
| Est. Completion | 2027-05-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06731075
The ClinicalTrials.gov registry entry for NCT06731075 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 300 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 3 interventions - of which Placebo capsule is the first listed.
NCT06731075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06731075 about?
NCT06731075 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.". ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this ...
What is the current status of trial NCT06731075?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2025-12-15. Estimated completion is 2027-05-22.
What interventions are being tested in trial NCT06731075?
The interventions under investigation include: Placebo capsule (OTHER), ORMD-0801 8 mg (DRUG), ORMD-0801 16 mg (DRUG).
Who is sponsoring clinical trial NCT06731075?
This trial is sponsored by Oramed, which has 11 total clinical trials registered on ClinicalTrials.gov.
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