Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brenipatide · 9 trials · 9 indications
To assess the asthma exacerbation rate.
| Arm | Type | Description |
|---|---|---|
| Brenipatide Dose 1 | EXPERIMENTAL | Brenipatide administered subcutaneous (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. |
| Standard of Care | DRUG | SOC |
| Buprenorphine | DRUG | Administered sublingual or buccal |
Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on 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 able...
Brenipatide is an investigational small molecule being studied for respiratory and central nervous system conditions. In clinical trials it is being evaluated for chronic obstructive pulmonary disease (COPD), bipolar disorder, opioid use disorder, and obesity or overweight. It is also listed for potential use in asthma, smoking, major depressive disorder, and schizophrenia.
Brenipatide is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company is conducting multiple clinical trials of the drug across different indications.
Brenipatide is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Active Phase 2 trials are recruiting for bipolar disorder and opioid use disorder, and a Phase 2 trial for COPD is not yet recruiting.
Brenipatide has four registered trials. NCT07286175 is a Phase 2 study in bipolar disorder with 400 participants. NCT07420283 is a Phase 2 study in opioid use disorder with 465 participants. NCT07476118 is a Phase 1 study in overweight or obesity with 150 participants. NCT07759245 is a Phase 2 study in COPD with 606 participants.
Yes, Brenipatide is also known as LY3537031. Two of its clinical trials, NCT07476118 and NCT07759245, use the LY3537031 name in their titles, confirming that both names refer to the same investigational drug.
Brenipatide belongs to the -tide (peptide) target class, indicating it is a peptide-based small molecule. Its specific molecular target has not been disclosed in the available clinical trial information.