A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 40
Inclusion Criteria
- 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)
- 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)
- Part A: Overtly healthy PMP females
Exclusion Criteria
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have known allergies to blosozumab, its constituents, or related compounds
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- ...
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have known allergies to blosozumab, its constituents, or related compounds
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Summary
- Conditions
- Osteoporosis, Postmenopausal
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Only females
Inclusion Criteria
- 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)
- 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)
- Part A: Overtly healthy PMP females
Exclusion Criteria
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have known allergies to blosozumab, its constituents, or related compounds
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- ...
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have known allergies to blosozumab, its constituents, or related compounds
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Tracking Information
- NCT #
- NCT02109042
- Collaborators
- Not Provided
- Investigators
- Study Director: 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
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