A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: Blosozumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02109042

I2M-MC-GSDM (Other Identifier)

15172

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Female

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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)