Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07502508 | Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy | PHASE2 | RECRUITING | 60 | — | — | Apr 1, 2026 | Jul 1, 2027 | May 12, 2026 | 16 | United States |
| NCT07502495 | Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets | PHASE2 | RECRUITING | 60 | — | — | Mar 27, 2026 | Jul 1, 2027 | May 12, 2026 | 16 | United States |
Mean change in HbA1c from baseline
| 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 icovamenib 100 mg 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). |
| Name | Type | Description |
|---|---|---|
| icovamenib 100 mg | DRUG | icovamenib 100 mg |
| Placebo | DRUG | Matching placebo |
| icovamenib 100mg | DRUG | icovamenib 100mg |
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 dose of...