NCT02337387

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 22, 2019

Completed
Last Updated

January 22, 2019

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

January 9, 2015

Results QC Date

September 27, 2017

Last Update Submit

August 3, 2018

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    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 Outcomes (3)

  • 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

  • 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

Study Arms (4)

Blosozumab Formulation A

EXPERIMENTAL

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

Blosozumab Formulation B

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Blosozumab (Part B)

EXPERIMENTAL

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

Interventions

BlosozumabBIOLOGICAL

Administered SC

Also known as: LY2541546
Blosozumab (Part B)Blosozumab Formulation ABlosozumab Formulation B
PlaceboOTHER

Administered SC

Placebo

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Covance

Daytona Beach, Florida, 32117, United States

Location

Covance Clinical Research Inc

Evansville, Indiana, 47710, United States

Location

Covance

Dallas, Texas, 75247-4989, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

blosozumab

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

Protocol stopping criteria (safety) were met. Non-serious AEs met criteria for stopping the study.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 22, 2019

Results First Posted

January 22, 2019

Record last verified: 2018-08

Locations

US(3)