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Also known as icovamenib 100mg
icovamenib · 3 trials · 2 indications
Mean change in HbA1c from baseline
Tmax
| Arm | Type | Description |
|---|---|---|
| Arm A: icovamenib 100 mg | EXPERIMENTAL | Starting on Day 1, participants will receive icovamenib 100 mg QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up) |
| Arm B: matching placebo 100 mg | PLACEBO_COMPARATOR | Starting on Day 1, participants will receive matching placebo QD in addition to their currently prescribed Ozempic (semaglutide injection)-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up). |
| Arm B: placebo matching 100 mg | PLACEBO_COMPARATOR | placebo matching 100mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks |
| Regimen A | EXPERIMENTAL | A - icovamenib capsule 100mg in fasted state |
| Regimen B | EXPERIMENTAL | B - icovamenib capsule 100mg in the fed state (0.5 h after initiation of low-fat breakfast) |
| Regimen C | EXPERIMENTAL | C - icovamenib capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast) |
| Regimen D | EXPERIMENTAL | D - icovamenib capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast) |
| Regimen E | EXPERIMENTAL | E - icovamenib capsule 100mg in the fed state (1 h after initiation of a high-fat breakfast) |
| Regimen F | EXPERIMENTAL | F - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a high-fat breakfast) |
| Regimen G | EXPERIMENTAL | G - icovamenib HPMC capsule 100mg in the fed state (1h after initiation of a high-fat breakfast) |
| Regimen H | EXPERIMENTAL | H - icovamenib HPMC capsule 100mg in the fed state (0.5 h after initiation of a low-fat breakfast) |
| Regimen I | EXPERIMENTAL | I - icovamenib HPMC capsule 100mg in the fed state (1 h after initiation of a low-fat breakfast) |
| Name | Type | Description |
|---|---|---|
| icovamenib 100 mg | DRUG | icovamenib 100 mg |
| Placebo | DRUG | Matching placebo |
| icovamenib 100mg | DRUG | icovamenib 100mg |
| Icovamenib | DRUG | Investigational Product |
| Icovamenib HPMC | DRUG | Investigational Product |
Key Inclusion Criteria: 1. Males or females, age ≥18 years and ≤70 years 2. Have been diagnosed with T2D 3. Taking Ozempic (semaglutide injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with a stable dos...
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Icovamenib is an investigational small molecule being studied for Type 2 Diabetes. It is also being evaluated in healthy volunteers for a food effect study. The drug is in clinical development by Biomea Fusion, Inc. and is not yet approved.
Icovamenib is a kinase inhibitor, as indicated by its '-nib' suffix. It is being studied for its potential role in treating Type 2 Diabetes. The specific molecular target has not been disclosed in clinical trial information.
Icovamenib is being developed by Biomea Fusion, Inc., a biopharmaceutical company traded under the ticker symbol BMEA. The company is conducting clinical trials of Icovamenib in the United States for Type 2 Diabetes and in healthy volunteers.
Icovamenib is in Phase 2 clinical development for Type 2 Diabetes. A Phase 1 food effect study in healthy volunteers has been completed. The drug is investigational and has not received FDA approval.
Icovamenib is being studied in two Phase 2 trials: NCT07502495 in participants with Type 2 Diabetes not achieving glycemic targets, and NCT07502508 in those not achieving targets while using GLP-1-based therapy. A Phase 1 food effect study, NCT07254286, has been completed.
Yes, Icovamenib is also known as icovamenib 100mg or icovamenib 100 mg. These names refer to the same drug substance being developed by Biomea Fusion, Inc. for Type 2 Diabetes.