Phase 1 Completed N=15 Basic Science

A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Osteoporosis, Postmenopausal

Source: ClinicalTrials.gov NCT02109042 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab — 59.8 picomoles per milliliter

Summary

The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected. This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug. There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab	59.8	—
PRIMARY PK: Area Under the Concentration Curve of Blosozumab	7160	—

Eligibility Criteria

Inclusion Criteria

Part A: Overtly healthy PMP females
Part B: PMP women who are currently taking oral bisphosphonates
Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)

Exclusion Criteria

Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have known allergies to blosozumab, its constituents, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02109042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.