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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: Clinical Trial Phase 3 study, sponsored by Oramed.
NCT06731075 is a Phase 3 study that has not yet begun recruiting, run by Oramed. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).
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 |
What is known before NCT06731075 opens enrollment
NCT06731075 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo capsule is the first listed.
NCT06731075 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06731075's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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