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 studied for metabolic conditions, including Type 2 Diabetes, overweight, and obesity. It is being evaluated in healthy participants and in people with Type 2 Diabetes, including those on stable doses of semaglutide or tirzepatide. The drug is not approved and remains in clinical development.
The molecular target of LY3457263 has not been disclosed. It is a small molecule developed by Eli Lilly and Company for metabolic indications, including Type 2 Diabetes and obesity. Clinical trials are evaluating its safety and efficacy, but the specific biological mechanism of action is not publicly detailed.
LY3457263 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting clinical trials of this investigational small molecule for Type 2 Diabetes, overweight, and obesity. Eli Lilly is the sponsor of the registered studies for LY3457263.
LY3457263 is in Phase 2 clinical development. Early Phase 1 studies in healthy participants and people with Type 2 Diabetes have been completed. A Phase 2 trial, NCT06897475, is currently recruiting participants with Type 2 Diabetes who are on a stable dose of semaglutide or tirzepatide. The drug is investigational and not FDA approved.
LY3457263 has been studied in several clinical trials. Completed Phase 1 trials include NCT04641312 in healthy participants and those with Type 2 Diabetes, NCT05377333 alone and with dulaglutide in Type 2 Diabetes, and NCT05582096 in obese participants. The active Phase 2 trial, NCT06897475, compares LY3457263 with placebo in Type 2 Diabetes patients on semaglutide or tirzepatide.
Yes, LY3457263 has been studied in combination with dulaglutide, a GLP-1 receptor agonist, in a completed Phase 1 trial (NCT05377333) for Type 2 Diabetes. Additionally, an ongoing Phase 2 trial (NCT06897475) is evaluating LY3457263 in patients already taking semaglutide or tirzepatide, though it compares the drug against placebo in that setting.