Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
icovamenib · 2 trials · 1 indication
Mean change in HbA1c from baseline
| Arm | Type | Description |
|---|---|---|
| Arm A: icovamenib 100 mg | EXPERIMENTAL | Starting on Day 1, participants will receive icovamenib or placebo 100 mg QD in addition to their currently prescribed GLP-1or GIP/GLP-1 RA 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 57 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 GLP-1-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of allowable GLP-1-based regimen. The total duration of the trial is approximately 57 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 |
| Name | Type | Description |
|---|---|---|
| icovamenib 100 mg | DRUG | icovamenib 100 mg |
| Placebo | DRUG | Matching placebo |
| icovamenib 100mg | DRUG | icovamenib 100mg |
Key Inclusion Criteria: 1. Males or females, age ≥18 years and ≤75 years 2. Have been diagnosed with T2D 3. Taking FDA-approved GLP-1 based therapy (administered as subcutaneous injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin...
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Icovamenib is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is being studied in adults with Type 2 Diabetes who are not achieving glycemic targets, including patients on GLP-1-based therapy. It is not approved and remains in clinical development.
Icovamenib targets menin. Menin is a protein that interacts with the menin-KMT2A pathway, and icovamenib is designed to inhibit menin. This mechanism is being evaluated in Type 2 Diabetes as a potential approach to improve glycemic control in patients who are not reaching treatment targets.
Icovamenib is being developed by Biomea Fusion, Inc., which trades under the ticker BMEA. The company is the sponsor of the clinical program evaluating icovamenib in Type 2 Diabetes.
Icovamenib is in Phase 2 clinical development for Type 2 Diabetes. It is investigational and has not been approved by the FDA. Two Phase 2 trials are ongoing, one recruiting and one active but not recruiting, with a combined planned enrollment of 124 participants.
Icovamenib is being evaluated in two Phase 2 trials in Type 2 Diabetes. NCT07502508 is a recruiting trial in participants not achieving glycemic targets on GLP-1-based therapy, enrolling 60 adults in the United States. NCT07502495 is an active, not recruiting trial in participants not achieving glycemic targets, enrolling 64 adults in the United States.