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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07400588 | Aleniglipron Phase 2 in Type 2 Diabetes Mellitus | PHASE2 | ACTIVE NOT_RECRUITING | 58 | — | — | Dec 1, 2025 | Sep 1, 2026 | Apr 27, 2026 | 16 | United States |
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Number of Participants with Clinically Significant Change from Baseline in Laboratory Parameters: including hematology, serum chemistry, coagulation
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
| Arm | Type | Description |
|---|---|---|
| Arm 1: Participants will receive aleniglipron administered orally | EXPERIMENTAL | Drug aleniglipron administered orally |
| Arm 2: Participants will receive a placebo administered orally | EXPERIMENTAL | Drug placebo administered orally |
| Name | Type | Description |
|---|---|---|
| Aleniglipron | DRUG | Drug aleniglipron administered orally |
| Placebo | DRUG | Drug placebo administered orally |
Inclusion Criteria: * Signed Informed Consent * A diagnosis of T2DM of ≥6 months, * Hemoglobin A1c (HbA1c) ≥6.5% to ≤10% at Screening * Have a BMI ≥27.0 kg/m2 Exclusion Criteria: * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. All particip...