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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 for patients with Type 2 Diabetes who are not achieving glycemic targets, including those using GLP-1-based therapy.
Icovamenib is a small molecule that belongs to the -nib (kinase) target class. It is being studied for its potential role in treating Type 2 Diabetes. The specific molecular target has not been disclosed in available clinical trial information.
Icovamenib is being developed by Biomea Fusion, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol BMEA. Biomea Fusion is conducting clinical trials to evaluate the drug's safety and efficacy in Type 2 Diabetes and healthy volunteers.
Icovamenib is currently in Phase 2 clinical development. It has completed a Phase 1 food effect study in healthy volunteers. Two Phase 2 trials are ongoing or active, studying the drug in participants with Type 2 Diabetes who are not achieving glycemic targets.
Icovamenib is being studied in three clinical trials. NCT07254286 is a completed Phase 1 food effect study in healthy volunteers. NCT07502495 is an active Phase 2 trial in Type 2 Diabetes patients not achieving glycemic targets. NCT07502508 is a recruiting Phase 2 trial in Type 2 Diabetes patients using GLP-1-based therapy.
Yes, Icovamenib is also known as icovamenib 100mg or icovamenib 100 mg. These names refer to the same drug substance. The 100mg designation likely indicates a specific dosage strength being studied in clinical trials.