Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY3209590 (SC), LY3209590 (Formulation 1)
LY3209590 · 10 trials · 3 indications
HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.
HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.
PK: AUCss of LY3209590
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
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 |
|---|---|---|
| LY3209590 Algorithm 1 (Paper) | EXPERIMENTAL | Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL). |
| LY3209590 Algorithm 2 (Digital) | EXPERIMENTAL | Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL. As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry. |
| Insulin Degludec | ACTIVE_COMPARATOR | Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL. |
| LY3209590 Algorithm 1 | EXPERIMENTAL | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of \<140 milligram per deciliter (mg/dL). |
| LY3209590 Algorithm 2 | EXPERIMENTAL | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of \<120 mg/dL. |
| LY3209590 | EXPERIMENTAL | LY3209590 administered subcutaneously (SC). |
| Insulin glargine | ACTIVE_COMPARATOR | Insulin glargine administered SC. |
| Placebo | ACTIVE_COMPARATOR | Participants from Cohort 1 and 2 received Placebo administered SC. |
| Insulin Glargine (Lantus) | ACTIVE_COMPARATOR | Insulin Glargine administered SC. |
| Name | Type | Description |
|---|---|---|
| LY3209590 | DRUG | Administered SC |
| Insulin Degludec | DRUG | Administered SC |
| Insulin Glargine | DRUG | Administered SC. |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year * Participants must have been using multiple daily injections without interruption for at least 3 months * Participants must have HbA1c values of 5.6% to 9.5%, inclusive * Participants must have...
LY3209590 is an investigational small molecule developed by Eli Lilly and Company for the treatment of diabetes. It has been studied in both Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. The program has reached Phase 2 clinical development, and nine clinical trials have been completed.
LY3209590 is being developed for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. Clinical studies have enrolled adults with both conditions, as well as pediatric participants aged 10 years and older with Type 2 Diabetes Mellitus. It remains investigational and is not an approved therapy.
LY3209590 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly has sponsored the clinical trial program for the asset across multiple countries, including the United States, Germany, China, Austria, Spain, and Puerto Rico.
LY3209590 has reached Phase 2 clinical development. Nine trials have been completed, including Phase 1 studies in Type 2 Diabetes Mellitus and a Phase 2 study in Type 1 Diabetes Mellitus. No trials are currently active, and the drug is investigational rather than approved.
Completed studies include NCT04450407, a Phase 2 trial in Type 1 Diabetes with 266 participants, and NCT06362265, a Phase 1 pharmacokinetic study in pediatric participants with Type 2 Diabetes. Other completed Phase 1 trials include NCT06169982 in Germany and NCT05596747 in Chinese participants with Type 2 Diabetes.
Yes. LY3209590 (SC) and LY3209590 (Formulation 1) are alternative names used for LY3209590, the Eli Lilly investigational small molecule for Type 1 and Type 2 Diabetes Mellitus. Searches using any of these names refer to the same development program.