Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2541546 - SC, LY2541546 - IV, Blosozumab
LY2541546 · 2 trials · 2 indications
Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA). Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance. Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
| Arm | Type | Description |
|---|---|---|
| 180 mg LY2541546 Q4W + Placebo | EXPERIMENTAL | LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. |
| 180 mg LY2541546 Q2W | EXPERIMENTAL | LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 270 mg LY2541546 Q2W | EXPERIMENTAL | LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| 270 mg LY2541546 Q12W + Placebo | EXPERIMENTAL | LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks. Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks. |
| Placebo Comparator Q2W | PLACEBO_COMPARATOR | Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks. |
| Blosozumab | EXPERIMENTAL | Weekly SC injections of blosozumab for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| LY2541546 | DRUG | Administered subcutaneously |
| Placebo | DRUG | Administered subcutaneously |
| Blosozumab | DRUG | Administered subcutaneously |
Inclusion Criteria: * Ambulatory, postmenopausal women, inclusive. * Have low bone mineral density (BMD), defined as a T-score or equivalent BMD absolute value (grams/square centimeter \[g/cm\^2\]) for the lumbar spine of between -3.5 and -2.0, inclusive. * Without language barrier, reliable, and w...
LY2541546 is an investigational small molecule being studied for the treatment of osteoporosis. It was evaluated in women with low bone mineral density, a condition that underlies osteoporosis and raises fracture risk. It is not an approved therapy and remains in clinical development.
LY2541546 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the clinical program evaluating the compound in osteoporosis, including a Phase 2 study conducted across the United States, Denmark, Estonia, Japan, and Lithuania.
LY2541546 has completed a Phase 2 clinical trial and is an investigational drug, not an approved medicine. The Phase 2 study enrolled 154 women with low bone mineral density. No active trials of LY2541546 are currently listed, and the compound has not been approved by the FDA for any indication.
LY2541546 has been studied in one completed Phase 2 trial, NCT01144377, titled A Study of LY2541546 in Women With Low Bone Mineral Density. The trial enrolled 154 women aged 45 years and older across the United States, Denmark, Estonia, Japan, and Lithuania, and it was randomized, double blind, and placebo controlled.
Yes. LY2541546 - SC and LY2541546 - IV are alternative designations for LY2541546, referring to subcutaneous and intravenous formulations of the same investigational compound. Searches for any of these names refer to the Eli Lilly small molecule studied in osteoporosis.
The Phase 2 trial NCT01144377 was a randomized, double blind, placebo controlled study of LY2541546 in 154 women with low bone mineral density. Participants were 45 years or older, all female, and healthy volunteers were not eligible. The study has been completed and enrolled patients across five countries.