5 completed, 1 not yet recruiting, 1 terminated, 1 unknown. 5 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 5 |
| Phase 3 | 3 | Not yet recruiting 1, Terminated 1, Unknown 1 |
Follow ORMD-0801: new trials by email Literature Review of ORMD-0801 trials Research Report on ORMD-0801
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. ORMD-0801 8 mg, Placebo capsule, ORMD-0801 16 mg - Type 2 Diabetes Mellitus | Phase 3 | Not yet recruiting | Oramed, Ltd. | 300 | 2025-12-15 | 2025-08-03 |
| Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus ORMD-0801 - Diabetes Mellitus, Type 2 | Phase 3 | Unknown | King Hamad University Hospital, Bahrain | 608 | 2021-10-01 | 2021-03-26 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus ORMD-0801, Placebo - T2DM (Type 2 Diabetes Mellitus) | Phase 3 | Terminated | Oramed, Ltd. | 346 | 2021-03-16 | 2023-02-09 |
| A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) ORMD-0801 (Insulin) capsule 8 mg BD, Placebo - Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Oramed, Ltd. | 32 | 2020-11-24 | 2024-08-07 |
| A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus ORMD-0801, Placebo - Diabetes Mellitus, Type 2 | Phase 2 | Completed | Oramed, Ltd. | 49 | 2020-11-23 | 2024-05-07 |
| A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus ORMD-0801 (qd), ORMD-0801 (bid), ORMD-0801 (tid) - Type 2 Diabetes Mellitus | Phase 2 | Completed | Oramed, Ltd. | 31 | 2016-10-01 | 2018-07-12 |
| Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus ORMD-0801, Placebo Comparator - Diabetes Type 2 | Phase 2 | Completed | Oramed, Ltd. | 188 | 2015-07-27 | 2019-11-13 |
| A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics ORMD-0801 Capsules, Placebo - Diabetes Mellitus Type 1 | Phase 2 | Completed | Oramed, Ltd. | 25 | 2014-03-01 | 2017-07-06 |
Diabetes Mellitus, Type 2 (7) · Diabetes Mellitus, Type 1 (1) · Non-alcoholic Fatty Liver Disease (1)
Oramed, Ltd. (7) · King Hamad University Hospital, Bahrain (1)
United States (7) · Israel (1)
Joel M Neutel, M. D. (3) · Miriam Kidron, Ph.D. (3) · Dr. Dalal Alromaihi (1) · Ele Ferrannini, M. D. (1) · Joel M Neutel, M.D. (1) · Miriam Kidron, PhD (1)