A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Biological: Blosozumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blosozumab Formulation A<br>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. | Biological: Blosozumab<br>* Administered SC<br>* Other names: LY2541546;|
| Experimental: Blosozumab Formulation B<br>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. | Biological: Blosozumab<br>* Administered SC<br>* Other names: LY2541546;|
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br>* Administered SC<br>|
| Experimental: Blosozumab (Part B)<br>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. | Biological: Blosozumab<br>* Administered SC<br>* Other names: LY2541546;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B |  | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose | 
| Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B |  | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B |  | Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose |