A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Phase 1

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Blosozumab

• Registration Number: NCT02109042
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2017-09
• Results First Submitted: 2017-09-27
• Results First Submitted QC: 2017-09-27
• Last Update Submitted: 2017-09-27
• Results First Posted: 2018-07-16
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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)

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blosozumab	Blosozumab	Weekly SC injections of blosozumab for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab	Predose and daily up through 7 days postdose	The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
PK: Area Under the Concentration Curve of Blosozumab	Predose and daily up through 7 days postdose	The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.

Trial Locations

Locations (1)

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