Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Brenipatide
LY3537031 · 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...
LY3537031, also known as brenipatide, is an investigational small molecule being developed by Eli Lilly and Company. It is in clinical development for alcohol use disorder, irritable bowel syndrome, end stage renal disease, and overweight. It has not been approved by the FDA and remains under study in Phase 2 and Phase 3 trials.
LY3537031 is being studied for alcohol use disorder, irritable bowel syndrome including constipation and diarrhea subtypes, end stage renal disease, and overweight. The most advanced program is in alcohol use disorder, where two Phase 3 trials are recruiting participants. The irritable bowel syndrome studies are in Phase 2.
LY3537031 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 for the drug, including the Phase 3 alcohol use disorder trials and the Phase 2 irritable bowel syndrome trials.
LY3537031 is in Phase 3 development for alcohol use disorder and Phase 2 development for irritable bowel syndrome. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials and two Phase 2 trials are currently recruiting, with total planned enrollment of about 3,073 participants across the program.
LY3537031 is being studied in four recruiting trials. NCT07219966 and NCT07219953 are Phase 3 trials in moderate-to-severe and general alcohol use disorder, each enrolling 1,100 participants. NCT07545772 is a Phase 2 trial in irritable bowel syndrome with constipation, and NCT07545759 is a Phase 2 trial in irritable bowel syndrome with diarrhea.
Yes, LY3537031 and brenipatide refer to the same investigational drug. Brenipatide is the alternate name used in trial titles, including the Phase 3 alcohol use disorder studies and the Phase 2 irritable bowel syndrome studies. Both names identify the same Eli Lilly small molecule in clinical development.