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

Phase 1

Terminated

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Other: Placebo; Biological: Blosozumab

• Registration Number: NCT02337387
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-13
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2017-09-27
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Results First Posted: 2019-01-22
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 28

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Blosozumab (Part B)	Blosozumab	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.
Blosozumab Formulation A	Blosozumab	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.
Blosozumab Formulation B	Blosozumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 85	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

Name	Time	Method
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
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

Trial Locations

Locations (2)

Covance; 🇺🇸 Dallas, Texas, United States

Covance Clinical Research Inc; 🇺🇸 Evansville, Indiana, United States