Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06731075 | A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. | PHASE3 | NOT YET_RECRUITING | 300 | — | — | Dec 15, 2025 | May 22, 2027 | Aug 3, 2025 | 1 | United States |
| NCT02954601 | A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 31 | — | — | Oct 1, 2016 | Mar 1, 2017 | Jul 11, 2018 | - | — |
Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).
| Arm | Type | Description |
|---|---|---|
| ORMD-0801 8 mg once-daily at night - QD | ACTIVE_COMPARATOR | Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night). |
| ORMD-0801 8 mg twice daily - BID | ACTIVE_COMPARATOR | Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night. |
| ORMD-0801 16 mg once-daily at night - QD | ACTIVE_COMPARATOR | Double-Dummy; the subject receives both experimental drug and placebo. 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning. |
| Placebo | PLACEBO_COMPARATOR | The subject receives 3 placebo capsules. |
| Name | Type | Description |
|---|---|---|
| ORMD-0801 8 mg | DRUG | 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night). |
| Placebo capsule | OTHER | Placebo capsule |
| ORMD-0801 16 mg | DRUG | 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning. |
| ORMD-0801 (qd) | DRUG | Dose 1 = ORMD-0801 (qd) |
| ORMD-0801 (bid) | DRUG | Dose 2 = ORMD-0801 (bid) |
| ORMD-0801 (tid) | DRUG | Dose 3 = ORMD-0801 (tid) |
| Placebo | OTHER | fish oil placebo |
Inclusion Criteria: * Male and female subjects aged ≥ 50 years. * Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.2% but ≤ 10.0% at Screening. * On a stable dose of at least one and up to three of the following glucose-lowering agents: Metformin, sulfonylurea, ...