Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin Efsitora Alfa · 5 trials · 5 indications
HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with treatment + country + CGM use prior to study entry \[yes/no\]+ carbohydrate counting for prandial insulin\[yes/no\] + baseline value of the dependent variable (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. * Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.
| Arm | Type | Description |
|---|---|---|
| Insulin Efsitora Alfa | EXPERIMENTAL | Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U. |
| Insulin Glargine | ACTIVE_COMPARATOR | Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments. |
| Insulin Degludec | ACTIVE_COMPARATOR | Participants who were treated with prestudy basal insulin and prandial insulin therapy (100 U/mL Insulin Lispro) received 100 U/mL of Insulin Degludec administered once daily (QD) for 52 weeks as subcutaneous injection, followed by a 5-week safety follow-up. |
| 500 U/mL - Insulin Efsitora | EXPERIMENTAL | Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC with meals as needed. |
| 100 U/mL - Insulin Glargine | ACTIVE_COMPARATOR | Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed. |
| 500 U/mL - Insulin Efsitora Alfa | EXPERIMENTAL | * Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator. |
| 100 U/mL - Insulin Degludec | ACTIVE_COMPARATOR | * Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period. * Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator. |
| Name | Type | Description |
|---|---|---|
| Insulin Efsitora Alfa | DRUG | Administered SC |
| Insulin Glargine | DRUG | Administered SC |
| Insulin Degludec | DRUG | Administered SC |
| Insulin Lispro (U100) | DRUG | Administered SC |
| Insulin Glargine (U100) | DRUG | Administered SC |
Inclusion Criteria: * Have a diagnosis of T2D according to the World Health Organization criteria. * Have an HbA1c of 7.0% to 10.0%, inclusive, at screening. * Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the...
Insulin efsitora alfa is an investigational once-weekly basal insulin developed by Eli Lilly and Company for the treatment of type 1 and type 2 diabetes. It is designed to provide basal insulin coverage with fewer injections than daily basal insulins. It has completed Phase 3 clinical development across multiple trials in adults with diabetes.
Insulin efsitora alfa targets the insulin receptor (INSR) and acts as an agonist. By binding to and activating INSR, it promotes glucose uptake and lowers blood glucose, functioning as a basal insulin. Its extended duration of action supports once-weekly dosing rather than daily administration.
Insulin efsitora alfa is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly conducted the Phase 3 QWINT clinical program evaluating the drug in type 1 and type 2 diabetes.
Insulin efsitora alfa has completed Phase 3 clinical development. Three Phase 3 trials are listed as completed, with no active trials ongoing. It is an investigational agent and is not described as approved by the FDA in the available information.
Insulin efsitora alfa has been studied in completed Phase 3 trials including NCT05662332 (QWINT-1) in type 2 diabetes, NCT05463744 in type 1 diabetes, NCT05462756 in type 2 diabetes on multiple daily injections, and NCT05362058 in type 2 diabetes starting basal insulin. Total enrollment across these trials was 2,511 participants.
Yes, insulin efsitora alfa is also known as LY3209590. The two names refer to the same investigational once-weekly basal insulin developed by Eli Lilly and Company. Clinical trial records for the Phase 3 QWINT program list the drug under both names.