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

August 3, 2018 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Inc
    • Texas
      • Dallas, Texas, United States, 75247-4989
        • Covance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Biological: Blosozumab
Administered SC
Other Names:
  • LY2541546
EXPERIMENTAL: 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.
Biological: Blosozumab
Administered SC
Other Names:
  • LY2541546
PLACEBO_COMPARATOR: 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.
Other: Placebo
Administered SC
EXPERIMENTAL: 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.
Biological: Blosozumab
Administered SC
Other Names:
  • LY2541546

What is the study measuring?

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
Time Frame: 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.
Baseline through Day 85

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
Time Frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
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
Time Frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
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
Time Frame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 9, 2015

First Posted (ESTIMATE)

January 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2019

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15728
  • I2M-MC-GSDT (OTHER: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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