A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
Completed · Phase 1
Conditions studied: Osteoporosis, Postmenopausal
In brief
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.
Key facts
- Study ID
- NCT02109042
- Run by
- Eli Lilly and Company
- People needed
- 15
- Starts
- 2014-04-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2018-07-16
Who can join
Age: 60 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Daytona Beach, Florida, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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