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

Lilly

Status and phase: Terminated; Phase 1

Conditions: Osteoporosis, Postmenopausal

Treatments: Other: Placebo; Biological: Blosozumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02337387

15728

I2M-MC-GSDT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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28 participants in 4 patient groups, including a placebo group

Blosozumab Formulation A

Experimental group

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.

Treatment:

Biological: Blosozumab

Blosozumab Formulation B

Experimental group

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.

Treatment:

Biological: Blosozumab

Placebo

Placebo Comparator group

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.

Treatment:

Other: Placebo

Blosozumab (Part B)

Experimental group

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.

Treatment:

Biological: Blosozumab