NCT02109042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4 years until next milestone

Results Posted

Study results publicly available

July 16, 2018

Completed
Last Updated

July 16, 2018

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

April 7, 2014

Results QC Date

September 27, 2017

Last Update Submit

September 27, 2017

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab

    The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.

    Predose and daily up through 7 days postdose

  • PK: Area Under the Concentration Curve of Blosozumab

    The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.

    Predose and daily up through 7 days postdose

Study Arms (1)

Blosozumab

EXPERIMENTAL

Weekly SC injections of blosozumab for 6 weeks.

Drug: Blosozumab

Interventions

BlosozumabDRUG

Administered subcutaneously

Also known as: LY2541546
Blosozumab

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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, 32117, United States

Location

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, 75247, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

blosozumab

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

Before Part B of the study, Eli Lilly and Company decided to stop any further dose administration; no participants entered Part B of the study. The decision was not based on safety concerns, but rather tolerability issues (injection site reactions).

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 16, 2018

Results First Posted

July 16, 2018

Record last verified: 2017-09

Locations

US(2)