Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2405319 · 2 trials · 2 indications
The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. |
| 3 mg LY2405319 | EXPERIMENTAL | Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days. |
| 10 mg LY2405319 | EXPERIMENTAL | Participants received 10 mg LY2405319 injected SC once daily for 28 days. |
| 20 mg LY2405319 | EXPERIMENTAL | Participants received 20 mg LY2405319 injected SC once daily for 28 days. |
| Name | Type | Description |
|---|---|---|
| LY2405319 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Have a diagnosis of T2DM. * Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen. * Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral ...
LY2405319 is an investigational small molecule being studied for the treatment of Type 2 Diabetes and Diabetes Mellitus, Type 2. It is in Phase 1 clinical development and is not approved by the FDA.
LY2405319 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY.
LY2405319 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
LY2405319 has been studied in two completed Phase 1 trials: NCT00481117, which enrolled 37 participants with Type 2 Diabetes across India, Mexico, New Zealand, and South Africa, and NCT01869959, which enrolled 47 participants with Type 2 Diabetes in the United States.
LY2405319 is a distinct investigational compound developed by Eli Lilly and Company. No alternative names for this drug have been reported.