Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3209590 · 14 trials · 4 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
PK: AUC(0-tlast) of LY3209590
PK: AUC(0-∞) of LY3209590
PK: Cmax of LY3209590
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
Part A: PK: AUC0-∞ of LY3209590
PK: Cmax of LY3209590
PK: AUC(0-inf) of LY3209590
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). |
| LY3209590 (Formulation 1) | EXPERIMENTAL | Single dose of LY3209590 as formulation 1 administered subcutaneously (SC). |
| LY3209590 (Formulation 2) | EXPERIMENTAL | Single dose of LY3209590 as formulation 2 administered SC. |
| Insulin glargine | ACTIVE_COMPARATOR | Insulin glargine administered SC. |
| LY3209590 (Part A - Upper Arm) | EXPERIMENTAL | LY3209590 administered subcutaneously (SC) into the upper arm |
| LY3209590 (Part A - Thigh) | EXPERIMENTAL | LY3209590 administered SC into the thigh |
| LY3209590 (Part A - Abdominal Wall) | EXPERIMENTAL | LY3209590 administered SC into the abdominal wall |
| LY3209590 (Part B - IV Dose) | EXPERIMENTAL | LY3209590 administered intravenously (IV) |
| LY3209590 (Part B - SC Dose) | EXPERIMENTAL | LY3209590 administered SC into the abdominal wall |
| Insulin Glargine (Period 1) | ACTIVE_COMPARATOR | Insulin glargine administered subcutaneously (SC). |
| LY3209590 (Period 2) | EXPERIMENTAL | LY3209590 administered SC. |
| LY3209590 Lyophilized Formulation | EXPERIMENTAL | LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods. |
| LY3209590 Solution Formulation | EXPERIMENTAL | LY3209590 as solution formulation administered SC in one of the two study periods. |
| 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 |
| LY3209590 (Formulation 1) | DRUG | Administered SC. |
| LY3209590 (Formulation 2) | DRUG | Administered SC. |
| Insulin Glargine | DRUG | Administered SC. |
| LY3209590 (SC) | DRUG | Administered SC. |
| LY3209590 (IV) | DRUG | Administered IV. |
| 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 being studied for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is being developed by Eli Lilly and Company for metabolic conditions, with clinical trials conducted in participants with these diabetes types as well as in healthy volunteers.
LY3209590 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker LLY. The company has sponsored multiple clinical trials of LY3209590 across different phases and countries.
LY3209590 is in clinical development, with trials completed in Phase 1 and Phase 2. The most advanced completed trial is a Phase 2 study in participants with Type 1 Diabetes Mellitus. It remains an investigational drug and is not approved for any use.
LY3209590 has been studied in six completed trials, including NCT04450407, a Phase 2 study in Type 1 Diabetes; NCT04768842, a Phase 1 formulation study in healthy participants; NCT05615532, a relative bioavailability study; and NCT05914688, a formulation comparison study.
LY3209590 is the primary identifier for this investigational drug. No alternative names have been established in the clinical trial data, so it is not known to be the same as any other marketed or investigational compound.