Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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). |
| 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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