Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3537031 · 9 trials · 11 indications
PK: AUC of LY3537031
PK: Cmax 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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| LY3537031 Period 1 | EXPERIMENTAL | Escalating doses administered subcutaneously (SC) |
| LY3537031 Period 2 | EXPERIMENTAL | Administered SC |
| Placebo | PLACEBO_COMPARATOR | Administered SC |
| LY3537031 | EXPERIMENTAL | LY3537031 administered subcutaneously (SC) |
| LY3537031 - Part A | EXPERIMENTAL | LY3537031 administered Subcutaneously (SC) in three different injection sites |
| LY3537031 - Part B | EXPERIMENTAL | LY3537031 administered Intravenously (IV) |
| LY3537031 (Group 1) | EXPERIMENTAL | Administered subcutaneously (SC) in participants with normal hepatic function |
| LY3537031 (Group 2) | EXPERIMENTAL | Administered SC in participants with mild hepatic impairment |
| LY3537031 (Group 3) | EXPERIMENTAL | Administered SC in participants with moderate hepatic impairment |
| LY3537031 (Group 4) | EXPERIMENTAL | Administered SC in participants with severe hepatic impairment |
| LY3537031 (Groups 2-3) | EXPERIMENTAL | LY3537031 administered SC in groups of participants with impaired renal function |
| 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 |
|---|---|---|
| LY3537031 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Participant must be a minimum of 20 years of age for the investigative sites in Japan. * Are seeking treatment and are motivated to stop or cut down on drinking. * Are reliable and willing to make themselves available for the duration of the study and attend required study vis...
LY3537031, also known as Brenipatide, is an investigational small molecule being studied for alcohol use disorder, irritable bowel syndrome with diarrhea (IBS-D), and irritable bowel syndrome with constipation (IBS-C). It is also being evaluated in healthy participants and those with renal impairment for pharmacokinetic studies.
LY3537031 is being developed by Eli Lilly and Company (NYSE: LLY). The company is conducting clinical trials of this investigational small molecule across multiple indications, including alcohol use disorder and irritable bowel syndrome.
LY3537031 is in Phase 3 clinical development for moderate-to-severe alcohol use disorder. It is also being studied in Phase 2 trials for irritable bowel syndrome with diarrhea and constipation, and a Phase 1 trial for renal impairment has been completed.
LY3537031 is being studied in several trials. NCT07219966 is a Phase 3 trial for alcohol use disorder. NCT07545759 and NCT07545772 are Phase 2 trials for IBS-D and IBS-C, respectively. NCT07165015, a Phase 1 renal impairment study, has been completed.
Yes, LY3537031 is also known as Brenipatide. Clinical trials use both names, such as NCT07545759, which is titled 'A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D).'
LY3537031 is not FDA approved. It is an investigational drug currently in clinical development, with Phase 3 trials recruiting for alcohol use disorder and Phase 2 trials recruiting for irritable bowel syndrome subtypes. Its safety and efficacy have not been established.