Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aleniglipron · 4 trials · 8 indications
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
Double Blind Period
Open -Label Extension
Open -Label Extension
Open -Label Extension
Open -Label Extension
Open -Label Extension
| Arm | Type | Description |
|---|---|---|
| aleniglipron Arm 1 | EXPERIMENTAL | Participants will receive aleniglipron administered orally. |
| aleniglipron Arm 2 | EXPERIMENTAL | Participants will receive aleniglipron administered orally. |
| aleniglipron Arm 3 | EXPERIMENTAL | Participants will receive aleniglipron administered orally. |
| Placebo Arm 4 | EXPERIMENTAL | Participants will receive placebo administered orally. |
| 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 |
| Cohort 1 | EXPERIMENTAL | Participants will receive Aleniglipron or Placebo administered orally. |
| Cohort 2 | EXPERIMENTAL | Participants will receive Aleniglipron or Placebo administered orally. |
| Cohort 3 | EXPERIMENTAL | Participants will receive Aleniglipron or Placebo administered orally. |
| Cohort 1 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Cohort 2 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Cohort 3 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Cohort 4 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Name | Type | Description |
|---|---|---|
| Aleniglipron | DRUG | Drug: aleniglipron administered orally Drug |
| Placebo | DRUG | Drug: placebo administered orally |
| Aleniglipron or Placebo | DRUG | Drug: Aleniglipron Administered orally Drug: Placebo Administered orally |
Inclusion Criteria: * Signed informed consent * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. Exclusion Criteria: * Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes. * Self-reported ch...
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