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Also known as LY3537031
Brenipatide · 15 trials · 17 indications
To assess the asthma exacerbation rate.
PK: AUC of LY3537031
PK: Cmax of LY3537031
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
| 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. |
| LY3537031 Period 1 | EXPERIMENTAL | Escalating doses administered subcutaneously (SC) |
| LY3537031 Period 2 | EXPERIMENTAL | Administered SC |
| LY3537031 | EXPERIMENTAL | LY3537031 administered subcutaneously (SC) |
| 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. |
| LY3537031 (Group 1) | EXPERIMENTAL | LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function |
| LY3537031 (Groups 2-3) | EXPERIMENTAL | LY3537031 administered SC in groups of participants with impaired renal function |
| LY3537031 (Group 3) | EXPERIMENTAL | LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis |
| LY3537031 Part A (Cohorts 1-7) | EXPERIMENTAL | Multiple-ascending doses of LY3537031 administered subcutaneously (SC) |
| Placebo Part A | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3537031 Part B (Cohorts 8-11) | EXPERIMENTAL | Multiple-ascending doses of LY3537031 administered SC |
| Placebo Part B | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3537031 Part C (Cohorts 12-15) | EXPERIMENTAL | Multiple-ascending doses of LY3537031 administered SC |
| Placebo Part C | PLACEBO_COMPARATOR | Placebo administered SC |
| LY3537031 Part D (Cohorts 16-19) | EXPERIMENTAL | Multiple-ascending doses of LY3537031 administered SC |
| Placebo Part D | PLACEBO_COMPARATOR | Placebo administered SC |
| Name | Type | Description |
|---|---|---|
| Brenipatide | DRUG | Administered SC. |
| Placebo | DRUG | Administered SC. |
| LY3537031 | 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 peptide developed by Eli Lilly and Company under the code LY3537031. It is being studied in clinical trials for several conditions, including major depressive disorder, chronic obstructive pulmonary disease, overweight or obesity, and opioid use disorder. It has not been approved by the FDA and remains in clinical development.
Brenipatide is being studied for major depressive disorder, moderate-to-severe chronic obstructive pulmonary disease, overweight or obesity, and opioid use disorder. Additional listed indications include asthma and bipolar disorder. It is investigational, so it is not approved for any use, and all current use is within clinical trials.
Brenipatide is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the clinical program, including a Phase 3 trial in major depressive disorder and Phase 2 trials in COPD and opioid use disorder.
Brenipatide is in Phase 2 development overall, with one Phase 3 trial and one Phase 1 trial also listed. The Phase 3 study in major depressive disorder is recruiting, and the Phase 2 COPD and opioid use disorder studies are recruiting. Brenipatide is investigational and has not been approved by the FDA.
Brenipatide trials include NCT07775300, a Phase 3 study in major depressive disorder enrolling about 1,000 adults, and NCT07759245, a Phase 2 COPD study enrolling about 606 adults. NCT07420283 is a Phase 2 opioid use disorder study, and NCT07476118 is a Phase 1 study in overweight or obesity.
Yes, Brenipatide is also known as LY3537031. Eli Lilly and Company uses LY3537031 as the internal code for the same investigational peptide, and both names appear in trial titles such as the Phase 3 major depressive disorder study and the Phase 2 COPD study.