Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brenipatide · 7 trials · 8 indications
To assess the asthma exacerbation rate.
| 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. |
| Part A and Part B: Brenipatide + Buprenorphine Dose 1 | EXPERIMENTAL | Part A: Brenipatide administered subcutaneously (SC) + Buprenorphine administered sublingual or buccal. Part B: Open-label Treatment: Participants will receive Brenipatide SC + Buprenorphine sublingual or buccal. |
| Part A: Brenipatide + Buprenorphine Dose 2 | EXPERIMENTAL | Brenipatide administered SC + Buprenorphine administered sublingual or buccal. |
| Part A: Brenipatide + Buprenorphine Dose 3 | EXPERIMENTAL | Brenipatide administered SC + Buprenorphine administered sublingual or buccal. |
| Part A: Placebo + Buprenorphine | PLACEBO_COMPARATOR | Placebo administered SC + Buprenorphine administered sublingual or buccal. |
| Brenipatide | EXPERIMENTAL | Brenipatide administered subcutaneously (SC) + SoC. |
| Brenipatide Dose 2 . | EXPERIMENTAL | Brenipatide administered subcutaneous (SC) + SoC. |
| Name | Type | Description |
|---|---|---|
| Brenipatide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Buprenorphine | DRUG | Administered sublingual or buccal |
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...