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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Blosozumab Formulation A

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.

Group Type EXPERIMENTAL

Blosozumab

Intervention Type BIOLOGICAL

Administered SC

Blosozumab Formulation B

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.

Group Type EXPERIMENTAL

Blosozumab

Intervention Type BIOLOGICAL

Administered SC

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered SC

Blosozumab (Part B)

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.

Group Type EXPERIMENTAL

Blosozumab

Intervention Type BIOLOGICAL

Administered SC

Interventions

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Blosozumab

Administered SC

Intervention Type BIOLOGICAL

Placebo

Administered SC

Intervention Type OTHER

Other Intervention Names

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LY2541546

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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes