Osteoporosis, PostmenopausalPhase 1NCT02109042

A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

A Phase 1 study testing Blosozumab in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female… Read more about this study

Who is it for?: Ages 60 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Osteoporosis, Postmenopausal
What is being tested?: Blosozumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: Apr 2014to Jul 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have known allergies to blosozumab, its constituents, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas, Texas, 75247
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women

This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug.

There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

Conditions: Osteoporosis, Postmenopausal
Being tested: Blosozumab
Medical subject headings: Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BlosozumabDrug
Also called LY2541546
Administered subcutaneously

Study groups in NCT02109042
Study group	Role	What they receive
Blosozumab	Experimental	Weekly SC injections of blosozumab for 6 weeks. Receives: Drug: Blosozumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
Measured: Predose and daily up through 7 days postdose
PK: Area Under the Concentration Curve of Blosozumab
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
Measured: Predose and daily up through 7 days postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jul 2014

First posted9 Apr 2014 (estimated)
Study startApr 2014
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02109042
Sponsor's protocol ID: 15172
Other IDs: I2M-MC-GSDM
Status last verified: Sep 2017
First submitted: 7 Apr 2014
Last updated: 16 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women
ClinicalTrials.gov ID: NCT02109042
Acronym / sponsor ID: 15172
Conditions: Osteoporosis, Postmenopausal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 9 Apr 2014 (estimated)
Results: Posted 16 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug.

There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Blosozumab	Experimental	Drug: BlosozumabWeekly SC injections of blosozumab for 6 weeks.

Who may qualify

Ages: 60 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (5 listed)

Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have known allergies to blosozumab, its constituents, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BlosozumabAlso: LY2541546Administered subcutaneously	Drug	Blosozumab

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
Time frame: Predose and daily up through 7 days postdose
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
PK: Area Under the Concentration Curve of Blosozumab
Time frame: Predose and daily up through 7 days postdose
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.

Results and safety

Results posted to the registry on 16 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Weekly Subcutaneous Blosozumab Injections	15	0

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab

Time frame: Predose and daily up through 7 days postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles per milliliter

Measure	Weekly SC Blosozumab Injections n = 15
Value	59.8 (54)

Population analysed: Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.

Primary outcome: PK: Area Under the Concentration Curve of Blosozumab

Time frame: Predose and daily up through 7 days postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles times hours per milliliter

Measure	Weekly SC Blosozumab Injections n = 15
Value	7160 (58)

Population analysed: Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
180 mg SC Blosozumab Injection	0 of 15 (0%)	14 of 15 (93.3%)	Not reported
90 mg SC Blosozumab Injections	0 of 15 (0%)	15 of 15 (100%)	Not reported

Limitations and caveats (from the sponsor): Before Part B of the study, Eli Lilly and Company decided to stop any further dose administration; no participants entered Part B of the study. The decision was not based on safety concerns, but rather tolerability issues (injection site reactions).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoporosis, Postmenopausal

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Blosozumab in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab (time frame: Predose and daily up through 7 days postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02109042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.