Osteoporosis, PostmenopausalPhase 1NCT02337387
A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
A Phase 1 study testing Blosozumab in people with Osteoporosis, Postmenopausal, run by Eli Lilly and Company at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 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?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to Mar 2015
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Covance
Dallas, Texas, 75247-4989
Covance
Daytona Beach, Florida, 32117
Covance Clinical Research Inc
Evansville, Indiana, 47710
About this study
Official title: 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Blosozumab, Placebo
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlosozumabBiological
Also called LY2541546
Administered SC
PlaceboOther
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Blosozumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Day 85
Secondary outcomes (3)
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
Measured: 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
Measured: 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
Measured: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Protocol stopping criteria (safety) were met.
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337387
- Sponsor's protocol ID
- 15728
- Other IDs
- I2M-MC-GSDT
- Status last verified
- Aug 2018
- First submitted
- 9 Jan 2015
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02337387
- Acronym / sponsor ID
- 15728
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol stopping criteria (safety) were met.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blosozumab Formulation A | Experimental | Biological: BlosozumabPart 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 | Experimental | Biological: BlosozumabPart 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. |
| Placebo | Placebo comparator | Other: PlaceboPart 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) | Experimental | Biological: BlosozumabPart 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 SC | Biological | Blosozumab (Part B), Blosozumab Formulation A, Blosozumab Formulation B |
| PlaceboAdministered SC | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
3 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 3 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: stopped early, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 22 Jan 2019). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2019.