HealthyPhase 1NCT01742091
A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women
A Phase 1 study testing LY2541546 - SC and LY2541546 - IV in people with Healthy, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY2541546 - SC and LY2541546 - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2009to Mar 2010
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy postmenopausal females, as determined by medical history and physical examination
- Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive
- Acceptable clinical laboratory test results, blood pressure and heart rate
- Have given written informed consent
Who cannot join
- Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
- Have received study treatment in any trial of an investigational osteoporosis treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12 weeks of screening or 5 half-lives, whichever is longer
- Known allergies to LY2541546, its constituents, or related compounds
- Persons who have previously participated in this study or any other study of LY2541546
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- History or presence of low platelet count, bleeding issues or family history of bleeding disorders
Show all 14Show fewer
- Paget's disease, parathyroid disease, or thyroid disease
- Fracture of a long bone within 12 weeks of screening
- Regular use of known drugs of abuse and/or positive findings on urinary drug screening
- Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen
- Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months
- Blood donation within the last month
- Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study or to abide by the clinical research unit restrictions. Note: Average weekly alcohol intake must not exceed 14 units per week
- Are unable or unwilling to refrain from nicotine usage during Clinical Research Unit (CRU) confinement
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 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.
Austin, Texas, 78752
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
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.
Evansville, Indiana, 47710
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.
Honolulu, Hawaii, 96813
About this study
Official title: A Multiple Dose Study of LY2541546 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Postmenopausal Women
The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.
- Conditions
- Healthy
- Being tested
- LY2541546 - SC, LY2541546 - IV, Placebo - SC, Placebo - IV
- Keywords
- Postmenopausal females, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2541546 - SCDrug
Also called Blosozumab
Administered SC
LY2541546 - IVDrug
Also called Blosozumab
Administered IV
Placebo - SCDrug
Administered SC
Placebo - IVDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| 180 mg LY2541546 SC Q4W | Experimental | 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. Receives: Drug: LY2541546 - SC; Drug: Placebo - SC |
| 270 mg LY2541546 SC Q2W | Experimental | 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. Receives: Drug: LY2541546 - SC |
| 270 mg LY2541546 SC Q4W | Experimental | 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. Receives: Drug: LY2541546 - SC; Drug: Placebo - SC |
| 540 mg LY2541546 IV Q4W | Experimental | 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. Receives: Drug: LY2541546 - IV; Drug: Placebo - IV |
| 750 mg LY2541546 IV Q2W | Experimental | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Receives: Drug: LY2541546 - IV |
| Placebo Q2W | Placebo comparator | Placebo administered IV or SC once every 2 weeks for 8 weeks. Receives: Drug: Placebo - SC; Drug: Placebo - IV |
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
An SAE is any AE from this study that results in one of the following outcomes:
- death
- initial or prolonged inpatient hospitalization
- a life-threatening experience (that is, immediate risk of dying)
- persistent or significant disability/incapacity
- congenital anomaly/birth defect
- is considered significant by the investigator for any other reason
Measured: Day 1 through Day 141
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546
Weekly AUC (AUC[0-tau]) during the first and last dosing interval for each participant receiving LY2541546 is reported.
Measured: Day 1 through Day 141
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.
Measured: Predose and Day 85
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Measured: Predose (Day 1) and Postdose (Day 29, 85 and 141)
Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.
Measured: Predose, through Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
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 HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 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
- NCT01742091
- Sponsor's protocol ID
- 13405
- Other IDs
- I2M-MC-GSDE
- Status last verified
- Sep 2017
- First submitted
- 3 Dec 2012
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study of LY2541546 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01742091
- Acronym / sponsor ID
- 13405
- Conditions
- Healthy
- Keywords
- Postmenopausal females, Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Posted 18 Jul 2018
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 assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 180 mg LY2541546 SC Q4W | Experimental | Drug: LY2541546 - SC, Drug: Placebo - SC180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. |
| 270 mg LY2541546 SC Q2W | Experimental | Drug: LY2541546 - SC270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. |
| 270 mg LY2541546 SC Q4W | Experimental | Drug: LY2541546 - SC, Drug: Placebo - SC270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. |
| 540 mg LY2541546 IV Q4W | Experimental | Drug: LY2541546 - IV, Drug: Placebo - IV540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. |
| 750 mg LY2541546 IV Q2W | Experimental | Drug: LY2541546 - IV750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. |
| Placebo Q2W | Placebo comparator | Drug: Placebo - SC, Drug: Placebo - IVPlacebo administered IV or SC once every 2 weeks for 8 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy postmenopausal females, as determined by medical history and physical examination
- Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive
- Acceptable clinical laboratory test results, blood pressure and heart rate
- Have given written informed consent
Key exclusion criteria (14 listed)
- Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
- Have received study treatment in any trial of an investigational osteoporosis treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12 weeks of screening or 5 half-lives, whichever is longer
- Known allergies to LY2541546, its constituents, or related compounds
- Persons who have previously participated in this study or any other study of LY2541546
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
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 |
|---|---|---|
| LY2541546 - SCAlso: BlosozumabAdministered SC | Drug | 180 mg LY2541546 SC Q4W, 270 mg LY2541546 SC Q2W, 270 mg LY2541546 SC Q4W |
| LY2541546 - IVAlso: BlosozumabAdministered IV | Drug | 540 mg LY2541546 IV Q4W, 750 mg LY2541546 IV Q2W |
| Placebo - SCAdministered SC | Drug | 180 mg LY2541546 SC Q4W, 270 mg LY2541546 SC Q4W, Placebo Q2W |
| Placebo - IVAdministered IV | Drug | 540 mg LY2541546 IV Q4W, Placebo Q2W |
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: Day 1 through Day 141
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * is considered significant by the investigator for any other reason
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546
Time frame: Day 1 through Day 141
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
Time frame: Predose and Day 85
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Time frame: Predose (Day 1) and Postdose (Day 29, 85 and 141)
Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Time frame: Predose, through Day 141
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- 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
5 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 LY2541546 - SC and LY2541546 - IV in people with Healthy, run by Eli Lilly and Company at 5 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 4 inclusion and 14 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 18 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 5 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 18 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?
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: Day 1 through Day 141). 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 18 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.