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| ID | Type | Description | Link |
|---|---|---|---|
| I2M-MC-GSDE | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 270 mg LY2541546 SC Q2W | Experimental | 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. |
|
| 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. |
|
| 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. |
|
| 750 mg LY2541546 IV Q2W | Experimental | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2541546 - SC | Drug | Administered SC |
|
| 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 | An SAE is any AE from this study that results in one of the following outcomes:
| Day 1 through Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 through Day 141 |
| Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 180 mg LY2541546 SC Q4W | 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. |
| FG001 | 270 mg LY2541546 SC Q2W | 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. |
| FG002 | 270 mg LY2541546 SC Q4W | 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. |
| FG003 | 540 mg LY2541546 IV Q4W | 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. |
| FG004 | 750 mg LY2541546 IV Q2W | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. |
| FG005 | Placebo Q2W | Placebo administered IV or SC once every 2 weeks for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 180 mg LY2541546 SC Q4W | 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. |
| BG001 | 270 mg LY2541546 SC Q2W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| All participants who received study drug. | Posted | Number | participants | Day 1 through Day 141 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 180 mg LY2541546 SC Q4W | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000593189 | blosozumab |
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| Placebo Q2W | Placebo Comparator | Placebo administered IV or SC once every 2 weeks for 8 weeks. |
|
| LY2541546 - IV | Drug | Administered IV |
|
|
| Placebo - SC | Drug | Administered SC |
|
| Placebo - IV | Drug | Administered IV |
|
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. |
| Predose and Day 85 |
| Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | 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. | Predose, through Day 141 |
| United States |
| 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 | United States |
| 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 | United States |
| 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 | United States |
| 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 | United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
| BG002 | 270 mg LY2541546 SC Q4W | 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. |
| BG003 | 540 mg LY2541546 IV Q4W | 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. |
| BG004 | 750 mg LY2541546 IV Q2W | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. |
| BG005 | Placebo Q2W | Placebo administered IV or SC once every 2 weeks for 8 weeks. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 270 mg LY2541546 SC Q2W |
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. |
| OG002 | 270 mg LY2541546 SC Q4W | 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. |
| OG003 | 540 mg LY2541546 IV Q4W | 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. |
| OG004 | 750 mg LY2541546 IV Q2W | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. |
| OG005 | Placebo Q2W | Placebo administered IV or SC once every 2 weeks for 8 weeks. |
|
|
| Secondary | 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. | All participants who received study drug and had sufficient evaluable results for PK analysis. | Posted | Mean | Standard Deviation | nanomole x hour per mililiter (nmol*h/mL | Day 1 through Day 141 |
|
|
|
| Secondary | 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. | All participants who received study drug and had evaluable BMD results at the analyzed time points. | Posted | Least Squares Mean | 90% Confidence Interval | gram per square centimeter (g/cm^2) | Predose and Day 85 |
|
|
|
| Secondary | Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies | All participants who received study drug and had evaluable antibody results at the analyzed time points. | Posted | Number | participants | Predose (Day 1) and Postdose (Day 29, 85 and 141) |
|
|
|
| Secondary | 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. | All participants who received study drug and had evaluable P1NP results at the analyzed time points. | Posted | Least Squares Mean | 90% Confidence Interval | microgram per liter (ug/L) | Predose, through Day 141 |
|
|
|
| 0 |
| 9 |
| 7 |
| 9 |
| EG001 | 270 mg LY2541546 SC Q2W | 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. | 0 | 11 | 11 | 11 |
| EG002 | 270 mg LY2541546 SC Q4W | 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. | 0 | 10 | 7 | 10 |
| EG003 | 540 mg LY2541546 IV Q4W | 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. | 0 | 9 | 5 | 9 |
| EG004 | 750 mg LY2541546 IV Q2W | 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. | 1 | 8 | 7 | 8 |
| EG005 | Placebo Q2W | Placebo administered IV or SC once every 2 weeks for 8 weeks. | 0 | 12 | 9 | 12 |
| Ear Congestion | Ear and labyrinth disorders | 12.0 | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | 12.0 | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | 12.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Gingival Bleeding | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 12.0 | Systematic Assessment |
|
| Chest Discomfort | General disorders | 12.0 | Systematic Assessment |
|
| Chills | General disorders | 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Discomfort | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Inflammation | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Mass | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Rash | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | 12.0 | Systematic Assessment |
|
| Injection Site Warmth | General disorders | 12.0 | Systematic Assessment |
|
| Pain | General disorders | 12.0 | Systematic Assessment |
|
| Sensation of Pressure | General disorders | 12.0 | Systematic Assessment |
|
| Vessel Puncture Site Haematoma | General disorders | 12.0 | Systematic Assessment |
|
| Vessel Puncture Site Pain | General disorders | 12.0 | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | 12.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | 12.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | 12.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | 12.0 | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Burns First Degree | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Joint Sprain | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | 12.0 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Decreased | Investigations | 12.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Head Discomfort | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | 12.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | 12.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | 12.0 | Systematic Assessment |
|
Not provided
| Last Dose |
|
| Day 29 |
|
| Day 85 |
|
| Day 141 |
|
| Day 85 |
|