Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2495655 · 4 trials · 4 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.
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) |
| 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 has been studied in advanced cancer, pancreatic cancer, muscle weakness, and muscular atrophy. Eli Lilly and Company sponsored trials in older adults who had fallen with muscle weakness, in participants with advanced cancer, in pancreatic cancer patients, and in older adults undergoing elective total hip replacement.
LY2495655 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the clinical trials evaluating the drug across oncology and muscle-related conditions.
LY2495655 is an investigational drug that has been tested in Phase 1 and Phase 2 clinical trials. The Phase 1 dose-escalation study in advanced cancer has completed, and several Phase 2 studies in pancreatic cancer, muscle weakness, and muscular atrophy have also completed.
LY2495655 has been evaluated in four completed trials: NCT01604408 in older participants with muscle weakness, NCT01524224 in advanced cancer, NCT01505530 in pancreatic cancer, and NCT01369511 in older participants undergoing elective total hip replacement. All four studies have completed.
LY2495655 is not approved and remains an investigational drug. It has completed Phase 1 and Phase 2 clinical trials in advanced cancer, pancreatic cancer, muscle weakness, and muscular atrophy, but no regulatory approval has been granted for any indication.