Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2495655 · 5 trials · 5 indications
Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.
Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.
The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.
Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
| Arm | Type | Description |
|---|---|---|
| LY2495655 | EXPERIMENTAL | Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks. |
| 300 mg LY2495655 + chemotherapy | EXPERIMENTAL | 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) |
| 100 mg LY2495655 + chemotherapy | EXPERIMENTAL | 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) |
| Placebo + chemotherapy | PLACEBO_COMPARATOR | Placebo in combination with standard of care chemotherapy (investigator's choice) |
| 35 mg LY2495655 | EXPERIMENTAL | LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) |
| 105 mg LY2495655 | EXPERIMENTAL | LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) |
| 315 mg LY2495655 | EXPERIMENTAL | LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times) |
| Single IV dose LY2495655 | EXPERIMENTAL | Single 70 milligram (mg) dose LY2495655 administered intravenously (IV) |
| Multiple SC dose 17.5 mg LY2495655 | EXPERIMENTAL | 17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
| Multiple SC dose 140 mg LY2495655 | EXPERIMENTAL | 140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses) |
| Multiple SC dose 420 mg LY2495655 | EXPERIMENTAL | 420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 doses) |
| Single IV dose placebo | PLACEBO_COMPARATOR | Single Placebo dose administered intravenously (IV) |
| Multiple SC dose placebo | PLACEBO_COMPARATOR | Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses) |
| Name | Type | Description |
|---|---|---|
| LY2495655 | BIOLOGICAL | Administered SC |
| Placebo | DRUG | Administered SC |
| Standard of Care Chemotherapy | DRUG | Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities). |
Inclusion Criteria: * Sustained at least 1 fall within 1 calendar year before study screening. * Requires ≥12 seconds to perform a repeated chair stands test or is unable to complete this test at screening. * Hand grip strength is ≤37 kilograms (kg) for men (81.4 pounds) or ≤21 kg for women (46.2 p...
LY2495655 is an investigational small molecule being studied for multiple conditions including muscular atrophy, muscle weakness, pancreatic cancer, and advanced cancer. It has also been evaluated in healthy volunteers. The drug is being developed by Eli Lilly and Company and is currently in clinical development, with studies completed in Phase 1 and Phase 2.
LY2495655 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule that has been studied in clinical trials for conditions such as muscular atrophy, muscle weakness, and pancreatic cancer.
LY2495655 is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains in clinical development. The most advanced studies completed include Phase 2 trials in muscular atrophy, pancreatic cancer, and muscle weakness, as well as a Phase 1 study in healthy volunteers.
LY2495655 has been studied in several clinical trials, including NCT01341470, a Phase 1 study in healthy subjects; NCT01369511, a Phase 2 study in older participants undergoing elective total hip replacement for muscular atrophy; NCT01505530, a Phase 2 study in participants with pancreatic cancer; and NCT01604408, a Phase 2 study in older participants who have fallen and have muscle weakness.
LY2495655 is the primary name used for this investigational drug in clinical trials. No alternative names have been disclosed in the available information. The drug is being studied under this identifier across multiple trials for conditions including muscular atrophy, muscle weakness, and pancreatic cancer.