Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ORMD-0801 QD, ORMD-0801 Capsules, Oral Insulin
ORMD-0801 · 8 trials · 7 indications
Change from baseline (Visit 1) in A1C at 26 weeks (Visit 6).
The safety of Oral Insulin will be measured by the number of treatment-related adverse events according to CTCAE version 5.0 A biostatistician reviewed the study data and determined that it is of poor quality and cannot be appropriately analyzed. Conclusions about this study cannot be made based on the study data.
The endogenous glucose production in ORMD-0801 and placebo measured by the glucose with tracer attached using AUC(0-16) as the primary parameter. The intravenous infusion of \[6,6-2H2\]-glucose tracer is administered following administraiton of either placebo or intervention. The pharmacokinetic time points are basline (pre dose), 0.75 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 hr, 12 hr, 13 hr, 14 hr, 15 hr, 16 hr post-dose.
Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C.
Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment)
The Effect of ORMD-0801 (Doses 1 \& 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.
Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.
| 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. |
| ORMD-0801 QD | EXPERIMENTAL | 16 mg QD, daily, in the morning (two capsules of ORMD--801, 8 mg each |
| ORMD-0801 | ACTIVE_COMPARATOR | Subjects will be administered a single 8mg capsule of ORMD-0801; study medication will be dispensed and subjects will dose twice a day, once in the morning prior to breakfast and once at night prior to bedtime. |
| Cohort A: ORMD-0801 once daily - QHS | ACTIVE_COMPARATOR | Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Cohort A: ORMD-0801 twice daily - BID | ACTIVE_COMPARATOR | Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. |
| Cohort A: ORMD-0801 three times daily - TID | ACTIVE_COMPARATOR | ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. |
| Cohort A: Matched Placebo Oral Capsule | PLACEBO_COMPARATOR | Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID) |
| Cohort A: Excipient-Matched Placebo three times daily-TID | PLACEBO_COMPARATOR | Excipient matched placebo in a non-randomized single-blind fashion, TID, dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch. This is an exploratory arm, per FDA. The results of this arm are not included in the primary analysis. |
| Cohort B:ORMD-0801, 8 mg once daily - QHS: | ACTIVE_COMPARATOR | ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Cohort B: ORMD-0801 8 mg twice daily - BID | ACTIVE_COMPARATOR | ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. |
| Cohort B: ORMD-0801 16 mg once daily - QHS: | ACTIVE_COMPARATOR | ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Cohort B: ORMD-0801 16 mg twice daily - BID | ACTIVE_COMPARATOR | ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast. |
| Cohort B - Matched Placebo Oral Capsule | PLACEBO_COMPARATOR | Cohort B - Matched Placebo Oral Capsule: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) |
| Dose1 | ACTIVE_COMPARATOR | Dose 1 ORMD-0801 (qd) |
| Dose2 | ACTIVE_COMPARATOR | Dose 2 ORMD-0801 (bid) |
| Dose 3 | ACTIVE_COMPARATOR | Dose 3 ORMD-0801 (tid) |
| Placebo Comparator | PLACEBO_COMPARATOR | three identical capsules containing placebo |
| ORMD-0801 Dose 1 | EXPERIMENTAL | three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo |
| ORMD-0801 Dose 2 = 1.5 * Dose 1 | EXPERIMENTAL | three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1 |
| ORMD-0801 Capsules | EXPERIMENTAL | API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801 |
| 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 | DRUG | 1 capsule ORMD 0801 3 times a day, before each meal |
| ORMD-0801 QD | DRUG | 16 mg, QD, two capsules, 8 mg each. |
| ORMD-0801 | DRUG | 8 mg capsules of ORMD-0801 (Oral Insulin) |
| Placebo | OTHER | Placebo capsule (Fish Oil) |
| Cohort A: ORMD-0801 | DRUG | Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2. Part 2: During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. |
| Placebo oral capsule | DRUG | Placebo provided QHS, BID, TID |
| Cohort B: ORMD-0801 | DRUG | Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1. Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia. |
| 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 Comparator | DRUG | Placebo |
| ORMD-0801 Capsules | BIOLOGICAL | API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules. |
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, ...
ORMD-0801 is an oral insulin capsule developed by Oramed Pharmaceuticals Inc. (ticker ORMP) as a small molecule therapy for metabolic disease. It is being studied in Type 2 diabetes mellitus, Type 1 diabetes, brittle Type 1 diabetes mellitus, and nonalcoholic steatohepatitis (NASH). The program is in Phase 2 development, with a Phase 3 trial planned in Type 2 diabetes.
ORMD-0801 targets the insulin receptor, known as INSR. By acting on INSR, the oral capsule is designed to deliver insulin activity through the gastrointestinal route rather than by injection. This receptor is central to glucose uptake and blood sugar regulation, which is why the program focuses on diabetes and related metabolic conditions.
ORMD-0801 is developed by Oramed Pharmaceuticals Inc., which trades under the ticker ORMP. The company is advancing the oral insulin candidate across diabetes and NASH indications, including a planned Phase 3 study in Type 2 diabetes mellitus in the United States.
ORMD-0801 is in Phase 2 development overall, with completed Phase 2 trials in Type 2 diabetes and NASH. A Phase 3 study, NCT06731075, is listed as not yet recruiting and is designed to evaluate efficacy and safety in Type 2 diabetes mellitus. ORMD-0801 is investigational and has not been approved by the FDA.
ORMD-0801 has been studied in several registered trials. Completed studies include NCT04616014 in Type 2 diabetes patients with NASH, NCT04564846 in Type 2 diabetes, and NCT03467932 in Type 2 diabetes. The Phase 3 trial NCT06731075 in Type 2 diabetes mellitus is not yet recruiting and plans to enroll 300 participants in the United States.
Yes. ORMD-0801 is also written as ORMD 0801, and related search terms include ORMD-0801 QD, ORMD-0801 (qd), ORMD-0801 Capsules, and ORMD-0801 8 mg. These refer to the same oral insulin candidate from Oramed Pharmaceuticals, including once-daily dosing and capsule formulations referenced in its clinical program.