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| ID | Type | Description | Link |
|---|---|---|---|
| I5S-EW-EFJA | Other Identifier | Eli Lilly and Company |
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This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will remain in the study for approximately up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3015014 intravenously (IV) | Experimental | A single dose of LY3015014 up to 10.0 milligrams per kilogram (mg/kg) administered IV |
|
| LY3015014 IV Japanese | Experimental | Single dose of LY3015014 10.0 mg/kg administered IV to Japanese participants. Added per protocol amendment effective October, 2012. |
|
| Placebo IV | Placebo Comparator | Administered IV once only |
|
| LY3015014 subcutaneously (SC) | Experimental | A single dose of LY3015014 up to 3.0 mg/kg administered SC |
|
| LY3015014 SC + Statin | Experimental | A single dose of LY3015014 up to 3 mg/kg administered SC in addition to participant's dose of statin |
|
| Placebo SC | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3015014 IV | Drug | Administered IV over 30-90 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module. | Baseline to study completion (up to 22 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration of LY3015014 [AUC(0-tlast)] | Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose | |
| PK: Maximum Concentration (Cmax) of LY3015014 |
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Inclusion Criteria:
Additional inclusion criteria for participants in the statin-interaction cohort:
Exclusion Criteria:
Additional exclusion criteria for participants in the statin-interaction cohort:
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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. | Glendale | California | 91206 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.03 mg/kg LY3015014 IV | A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV). |
| FG001 | 0.1 mg/kg LY3015014 IV | A single dose of 0.1 mg/kg LY3015014 administered IV. |
| FG002 | 0.3 mg/kg LY3015014 IV | A single dose of 0.3 mg/kg LY3015014 administered IV. |
| FG003 | 1.0 mg/kg LY3015014 IV | A single dose of 1.0 mg/kg LY3015014 administered IV. |
| FG004 | 3.0 mg/kg LY3015014 IV | A single dose of 3.0 mg/kg LY3015014 administered IV. |
| FG005 | 3.0 mg/kg LY3015014 SC | A single dose of 3.0 mg/kg LY3015014 administered SC. |
| FG006 | 3.0 mg/kg LY3015014 SC +Statin | A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose. |
| FG007 | 10.0 mg/kg LY3015014 IV | A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants. |
| FG008 | Placebo | A single dose of placebo administered IV or SC with a statin add-on dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.03 mg/kg LY3015014 IV | A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV). |
| BG001 | 0.1 mg/kg LY3015014 IV | A single dose of 0.1 mg/kg LY3015014 administered IV. |
| 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 Clinically Significant Effects | Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module. | All randomized participants. | Posted | Count of Participants | Participants | No | Baseline to study completion (up to 22 weeks) |
|
Up To 22 weeks
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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 | 0.03 mg/kg LY3015014 IV | A single dose of 0.03 mg/kg LY3015014 administered IV. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 14.1 | 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 |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Administered SC once only
|
| Placebo IV | Drug | Administered IV only over 30-90 minutes |
|
| LY3015014 SC | Drug | Administered SC |
|
| Placebo SC | Drug | Administered SC |
|
| Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Least Square means were calculated using mixed-effects models for repeated measures analysis. The model included factors for treatment, visits and baseline LDL-C. Percent change = (LDL value on Days 15 or 29 - LDL at baseline) / LDL at baseline *100. | Baseline, Days 15 and 29 |
| Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Days 8, 29 and 85 |
| 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 |
| 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. | Madison | Wisconsin | 53704 | United States |
| BG002 | 0.3 mg/kg LY3015014 IV | A single dose of 0.3 mg/kg LY3015014 administered IV. |
| BG003 | 1.0 mg/kg LY3015014 IV | A single dose of 1.0 mg/kg LY3015014 administered IV. |
| BG004 | 3.0 mg/kg LY3015014 IV | A single dose of 3.0 mg/kg LY3015014 administered IV. |
| BG005 | 3.0 mg/kg LY3015014 SC | A single dose of 3.0 mg/kg LY3015014 administered SC. |
| BG006 | 3.0 mg/kg LY3015014 SC +Statin | A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose. |
| BG007 | 10.0 mg/kg LY3015014 IV | A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants. |
| BG008 | Placebo | A single dose of placebo administered IV or SC with a statin add-on dose. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 0.1 mg/kg LY3015014 IV | A single dose of 0.1 mg/kg LY3015014 administered IV. |
| OG003 | 0.3 mg/kg LY3015014 IV | A single dose of 0.3 mg/kg LY3015014 administered IV. |
| OG004 | 1.0 mg/kg LY3015014 IV | A single dose of 1.0 mg/kg LY3015014 administered IV. |
| OG005 | 3.0 mg/kg LY3015014 IV | A single dose of 3.0 mg/kg LY3015014 administered IV. |
| OG006 | 3.0 mg/kg LY3015014 SC | A single dose of 3.0 mg/kg LY3015014 administered SC. |
| OG007 | 3.0 mg/kg LY3015014 SC +Statin | A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose. |
| OG008 | 10.0 mg/kg LY3015014 IV | A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration of LY3015014 [AUC(0-tlast)] | All randomized participants who received LY3015014 and had PK data to calculate AUC(0-tlast). | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms *hour/milliliter (µg*h/mL) | Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY3015014 | All randomized participants who received LY3015014 and had PK data to calculate Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose |
|
|
|
| Secondary | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Least Square means were calculated using mixed-effects models for repeated measures analysis. The model included factors for treatment, visits and baseline LDL-C. Percent change = (LDL value on Days 15 or 29 - LDL at baseline) / LDL at baseline *100. | All randomized participants with evaluable LDL-C data at specified time points. | Posted | Least Squares Mean | 90% Confidence Interval | percentage of change | Baseline, Days 15 and 29 |
|
|
|
| Secondary | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | All randomized participants. | Posted | Count of Participants | Participants | No | Days 8, 29 and 85 |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | 0.1 mg/kg LY3015014 IV | A single dose of 0.1 mg/kg LY3015014 administered IV. | 0 | 6 | 4 | 6 |
| EG002 | 0.3 mg/kg LY3015014 IV | A single dose of 0.3 mg/kg LY3015014 administered IV. | 0 | 6 | 2 | 6 |
| EG003 | 1.0 mg/kg LY3015014 IV | A single dose of 1.0 mg/kg LY3015014 administered IV. | 0 | 6 | 3 | 6 |
| EG004 | 3.0 mg/kg LY3015014 IV | A single dose of 3.0 mg/kg LY3015014 administered IV. | 0 | 6 | 3 | 6 |
| EG005 | 3.0 mg/kg LY3015014 SC | A single dose of 3.0 mg/kg LY3015014 administered SC. | 0 | 6 | 6 | 6 |
| EG006 | 3.0 mg/kg LY3015014 SC +Statin | A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose. | 0 | 6 | 3 | 6 |
| EG007 | 10.0 mg/kg LY3015014 IV | A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants. | 0 | 10 | 6 | 10 |
| EG008 | Placebo | A single dose of placebo administered IV or SC with a statin add-on dose. | 0 | 17 | 13 | 17 |
| Thyroid mass | Endocrine disorders | MedDRA 14.1 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Tinea cruris | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Wound infection staphylococcal | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Electrocardiogram pr prolongation | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Decreased vibratory sense | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sinus operation | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
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| Day 29 |
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| Day 29 |
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| Day 85 |
|