Back to resultsA Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Primary Purpose
Osteoporosis, Postmenopausal
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Blosozumab
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Osteoporosis, Postmenopausal
Eligibility Criteria
Inclusion Criteria:
- Part A: Overtly healthy postmenopausal (PMP) females
- Part B: PMP women who are currently taking oral bisphosphonates for prevention or treatment of osteoporosis
- Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
Exclusion Criteria:
- Have known allergies to blosozumab, its constituents, or related compounds
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- History of breast carcinoma
- Fracture of a long bone within 1 year of screening
- Have used teriparatide within 3 years prior to screening
Sites / Locations
- Covance
- Covance Clinical Research Inc
- Covance
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
Blosozumab Formulation A
Blosozumab Formulation B
Placebo
Blosozumab (Part B)
Arm Description
Part A. Blosozumab administered as 2 subcutaneous (SC) injections in week 1 followed by once weekly (QW) injections SC in weeks 2 to 6, followed by six week follow-up period.
Part A. Blosozumab administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
Part A. Placebo administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
Part B. Blosozumab formulation determined by Part A administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
Outcomes
Primary Outcome Measures
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
Secondary Outcome Measures
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02337387
Brief Title
A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Official Title
A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Protocol stopping criteria (safety) were met.
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause.
This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blosozumab Formulation A
Arm Type
Experimental
Arm Description
Part A. Blosozumab administered as 2 subcutaneous (SC) injections in week 1 followed by once weekly (QW) injections SC in weeks 2 to 6, followed by six week follow-up period.
Arm Title
Blosozumab Formulation B
Arm Type
Experimental
Arm Description
Part A. Blosozumab administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Part A. Placebo administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
Arm Title
Blosozumab (Part B)
Arm Type
Experimental
Arm Description
Part B. Blosozumab formulation determined by Part A administered as 2 SC injections in week 1 followed by QW injections SC in weeks 2 to 6, followed by six week follow-up period.
Intervention Type
Biological
Intervention Name(s)
Blosozumab
Other Intervention Name(s)
LY2541546
Intervention Description
Administered SC
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
Time Frame
Baseline through Day 85
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
Time Frame
Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Title
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
Time Frame
Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Title
Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
Time Frame
Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Part A: Overtly healthy postmenopausal (PMP) females
Part B: PMP women who are currently taking oral bisphosphonates for prevention or treatment of osteoporosis
Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2)
Exclusion Criteria:
Have known allergies to blosozumab, its constituents, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG)
History of breast carcinoma
Fracture of a long bone within 1 year of screening
Have used teriparatide within 3 years prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Covance
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Covance Clinical Research Inc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Covance
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247-4989
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
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