Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2541546, LY2541546 - SC, LY2541546 - IV
Blosozumab · 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...
Blosozumab is an investigational monoclonal antibody being developed by Eli Lilly and Company for postmenopausal osteoporosis. It has completed a Phase 1 clinical trial in postmenopausal women. It is not approved for any indication and remains in clinical development.
Blosozumab is being studied for the treatment of postmenopausal osteoporosis, a condition of reduced bone mass in women after menopause. Its only recorded clinical trial enrolled postmenopausal women aged 60 years and older. The drug is investigational and has not been approved for this or any other use.
Blosozumab targets SOST, the gene and protein also known as sclerostin. It is an inhibitor of sclerostin, a protein that normally restrains bone formation. By binding and inhibiting sclerostin, blosozumab is designed to increase bone formation, which is the rationale for studying it in postmenopausal osteoporosis.
Blosozumab is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the drug's clinical program in postmenopausal osteoporosis.
Blosozumab is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials. The drug is investigational and has not been approved by the FDA or any other regulatory agency for postmenopausal osteoporosis or any other indication.
Blosozumab has been studied in one completed Phase 1 trial, NCT02109042, titled A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants. The trial enrolled 15 participants in the United States, was uncontrolled, and included healthy volunteers who were female and at least 60 years old.