Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3938577 · 3 trials · 4 indications
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
PK: AUC of LY3938577 for intravenous administration
PK: AUC of LY3938577
PK: AUC of LY3938577 for SC administration
PK: AUC of LY3938577 for SC administration
PK: Cmax of LY3938577
PK: Cmax of LY3938577
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| LY3938577 | EXPERIMENTAL | Participants will receive LY3938577 subcutaneously (SC) |
| Degludec | ACTIVE_COMPARATOR | Participants will receive degludec SC |
| Part A Period 1: LY3938577 | EXPERIMENTAL | Single dose of LY3938577 administered intravenously (IV) in healthy participants. |
| Part A Period 1: Placebo | PLACEBO_COMPARATOR | Single dose of Placebo administered intravenously (IV) in healthy participants. |
| Part B: LY3938577 | EXPERIMENTAL | For each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of LY3938577 administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level. |
| Part B: Insulin Degludec | ACTIVE_COMPARATOR | For each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of Insulin Degludec administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level. |
| Part C: LY3938577 | EXPERIMENTAL | LY3938577 administered subcutaneously (SC) |
| Part C: Insulin Degludec | ACTIVE_COMPARATOR | Insulin Degludec administered subcutaneously (SC) |
| Part A Period 2: LY3938577 | EXPERIMENTAL | Sequential dose of LY3938577 administered subcutaneously (SC). |
| Part A Period 2: Placebo | PLACEBO_COMPARATOR | Sequential dose of Placebo administered subcutaneously (SC) |
| Part D Period 1: Basal Insulin and Lispro Prandial Insulin | OTHER | Pre-study basal insulin (provided by patient) and lispro prandial insulin administered SC |
| Part D Period 2: Lispro Prandial Insulin and LY3938577 | EXPERIMENTAL | Lispro prandial insulin and LY3938577 administered SC |
| LY3938577 (Part A) | EXPERIMENTAL | LY3938577 administered Subcutaneously (SC). |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered SC. |
| Insulin degludec (Part A) | ACTIVE_COMPARATOR | Insulin degludec administered SC. |
| LY3938577 (Part B) | EXPERIMENTAL | LY3938577 administered SC. |
| Insulin degludec (Part B) | ACTIVE_COMPARATOR | Insulin degludec administered SC. |
| Name | Type | Description |
|---|---|---|
| LY3938577 | DRUG | Administered SC |
| Degludec | DRUG | Administered SC |
| Placebo | DRUG | Administered Intravenously (IV) |
| Insulin Degludec | DRUG | Administered Intravenously (IV) |
| Insulin Lispro | DRUG | Administered Intravenously (IV) |
| Basal Insulin | DRUG | Administered subcutaneously (SC) |
| Lispro Prandial Insulin | DRUG | Administered subcutaneously (SC) |
Inclusion Criteria: * Have type 2 diabetes * Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening * Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive * Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)...
LY3938577 is an investigational small molecule being developed by Eli Lilly and Company for metabolic conditions, specifically Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is not yet approved and remains in clinical development. It is being studied in placebo-controlled, randomized, double-blind trials.
LY3938577 is being studied for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is an investigational therapy and has not been approved for any indication. Clinical trials are evaluating its safety and tolerability in adults with these conditions.
LY3938577 is being developed by Eli Lilly and Company, which trades under the ticker symbol LLY. Lilly is the sponsor of the clinical trials evaluating the drug in Type 1 and Type 2 Diabetes Mellitus.
LY3938577 is in Phase 1 clinical development, with one Phase 2 trial also listed. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 trials have been completed, and a Phase 2 trial is active but not recruiting.
LY3938577 has been studied in three clinical trials. NCT06280703 was a completed Phase 1 trial in healthy participants and those with Type 1 Diabetes in Germany. NCT06132126 was a completed Phase 1 trial in healthy participants and those with Type 2 Diabetes in the United States. NCT07215312 is an active Phase 2 trial in participants with Type 2 Diabetes previously treated with basal insulin, conducted in the United States and Argentina.