Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORMD-0801 · 6 trials · 5 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.
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. |
| 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 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) |
| 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 investigational oral insulin being studied for multiple metabolic conditions, including Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, and Nonalcoholic Steatohepatitis (NASH). It is being developed as a potential treatment to manage blood sugar levels and reduce liver fat content in affected patients.
ORMD 0801 is being developed by Oramed Pharmaceuticals Inc., a biopharmaceutical company traded under the ticker ORMP. The company is focused on advancing oral formulations of insulin and other peptide-based therapies for metabolic diseases.
ORMD 0801 is currently in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing and completed trials are all Phase 2 studies evaluating its safety and efficacy in patients with Type 1 diabetes, Type 2 diabetes, and NASH.
ORMD 0801 has been studied in several Phase 2 trials, including NCT00867594 in brittle Type 1 diabetes, NCT02094534 in Type 1 diabetes, NCT02496000 in Type 2 diabetes, and NCT04616014 in Type 2 diabetes with NASH. These trials have collectively enrolled 331 participants across Israel, the United States, and Belgium.
Yes, ORMD 0801 is also known as ORMD-0801 8 mg. The drug is an oral insulin capsule formulation, and the 8 mg designation refers to a specific dosage strength being evaluated in clinical trials. Both names refer to the same investigational product.
ORMD 0801 is an oral insulin formulation designed to deliver insulin through the gastrointestinal tract. It is being studied to replace or reduce the need for injected insulin in diabetic patients, potentially improving glycemic control and addressing liver fat accumulation in NASH patients.