Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3457263 · 4 trials · 5 indications
A summary of TEAEs, SAEs and other non-serious adverse events (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 |
|---|---|---|
| LY3457263 Dose 1 | EXPERIMENTAL | Participants will receive LY3457263 subcutaneously (SC) |
| LY3457263 Dose 2 | EXPERIMENTAL | Participants will receive LY3457263 SC |
| LY3457263 Dose 3 | EXPERIMENTAL | Participants will receive LY3457263 SC |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| LY3457263 + Tirzepatide | EXPERIMENTAL | LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC. |
| Placebo + Tirzepatide | PLACEBO_COMPARATOR | Placebo administered SC in combination with tirzepatide given SC. |
| LY3457263 (Alone) | EXPERIMENTAL | LY3457263 administered subcutaneously (SC). |
| Placebo (Alone) | PLACEBO_COMPARATOR | Placebo administered SC. |
| LY3457263 + Dulaglutide | EXPERIMENTAL | LY3457263 in combination with dulaglutide administered SC. |
| Placebo + Dulaglutide | EXPERIMENTAL | Placebo in combination with dulaglutide administered SC. |
| LY3457263 - Part A | EXPERIMENTAL | Escalating single doses of LY3457263 administered subcutaneously (SC) to healthy participants |
| Placebo - Part A | PLACEBO_COMPARATOR | Placebo administered SC to healthy participants |
| LY3457263 - Part B | EXPERIMENTAL | Escalating single doses of LY3457263 administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes |
| Placebo - Part B | PLACEBO_COMPARATOR | Placebo administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes |
| Name | Type | Description |
|---|---|---|
| LY3457263 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC. |
| Dulaglutide | DRUG | Administered SC. |
Inclusion Criteria: * Have type 2 diabetes * Have HbA1c ≥7.5% to ≤10.5% at screening * Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening * Have had a stable body weight for the three months prior to screening * On stable treatment dose of one of the following incre...
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LY3457263 is an investigational small molecule being developed by Eli Lilly and Company for metabolic conditions, including type 2 diabetes and overweight. It is designed to act on the GLP-1 receptor and is given as an oral therapy. The drug remains in clinical development and is not approved for any indication.
LY3457263 is being studied for the treatment of type 2 diabetes, including in patients already taking stable doses of semaglutide or tirzepatide. It is also being evaluated in people who are overweight or obese. All of these uses are investigational and have not been approved by regulators.
LY3457263 targets the GLP-1 receptor, the same receptor class engaged by approved GLP-1 based therapies. By acting on this receptor, the small molecule is intended to influence glucose control and body weight. It is an oral small molecule rather than a peptide injection.
LY3457263 is being 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 asset across type 2 diabetes and overweight or obesity indications.
LY3457263 is in Phase 1 development overall, with a Phase 2 study now recruiting. The Phase 1 program includes completed studies in healthy participants, participants with type 2 diabetes, and participants with obesity. The drug is investigational and has not been approved for any use.
The active study is NCT06897475, a Phase 2 trial of LY3457263 versus placebo in participants with type 2 diabetes on stable semaglutide or tirzepatide, enrolling about 200 people across the United States, Canada, Germany, Poland, Puerto Rico, and the United Kingdom. Completed Phase 1 trials include NCT05582096, NCT05377333, and NCT04641312.