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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07412756 | A Study of Brenipatide in Adult Participants With Major Depressive Disorder | PHASE3 | RECRUITING | 1,000 | — | — | Feb 9, 2026 | Feb 1, 2028 | Mar 23, 2026 | 186 | United States, Australia +13 |
| Arm | Type | Description |
|---|---|---|
| Brenipatide Dose 1 | EXPERIMENTAL | Brenipatide administered subcutaneously (SC) + standard of care (SoC). |
| Brenipatide Dose 2 | EXPERIMENTAL | Brenipatide administered SC + SoC |
| Brenipatide Dose 3 | EXPERIMENTAL | Brenipatide administered SC + SoC |
| Placebo | PLACEBO_COMPARATOR | Placebo administered SC + SoC. |
| Name | Type | Description |
|---|---|---|
| Brenipatide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on a stable standard of care medication for major depressive disorder * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and ab...