Hyperlipidemia
Conditions
Brief summary
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.
Interventions
DRUGLY3015014 IV
Administered IV over 30-90 minutes
DRUGPlacebo IV
Administered IV only over 30-90 minutes
DRUGLY3015014 SC
Administered SC
DRUGPlacebo SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination * To qualify as Japanese for the purpose of this study, the participant must be first-generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan. Japanese participants have to be between the ages of 20-65, inclusive, at screening * Statin naive participants, have a screening LDL-C of between 100 and 180 milligrams per deciliter (mg/dL), inclusive; for participants currently taking a statin, have a screening LDL-C of between 100 and 160 mg/dL * Have serum triglycerides \<400 mg/dL Additional inclusion criteria for participants in the statin-interaction cohort: * At screening, must have been on a stable dose of either atorvastatin \[10 to 40 mg once daily (QD)\], rosuvastatin (5 to 20 mg QD), simvastatin (20 to 40 mg QD), lovastatin (40 to 80 mg QD), or pravastatin (40 to 80 mg QD) which has been well tolerated for at least 3 months
Exclusion criteria
* Have known allergies to compounds related to LY3015014 or any components of the formulation, or known clinically significant hypersensitivity to biologic agents, or known allergies to acetaminophen and/or antihistamines * Intend to use over-the-counter or prescription medication within 14 days prior to dosing (excluding the statins listed in Inclusion Criterion), other than estrogen/progesterone as hormone replacement therapy (HRT) and thyroid medications. Participants taking these medications should be on chronic, stable doses. Certain medications, for example vitamin supplements, may be permitted at the discretion of the investigator and the sponsor. Participants on statins may be allowed to be on a stable dose of single hypertensive agent if agreed upon by sponsor and investigator * Have received any vaccine(s) within 1 month of LY3015014 dosing, or intend to during the study * Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing * Have a history of atopy, or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions \[including, but not limited to, erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis\] Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Baseline to study completion (up to 22 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | Baseline, Days 15 and 29 | 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. |
| Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Days 8, 29 and 85 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.03 mg/kg LY3015014 IV A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV). | 6 |
| 0.1 mg/kg LY3015014 IV A single dose of 0.1 mg/kg LY3015014 administered IV. | 6 |
| 0.3 mg/kg LY3015014 IV A single dose of 0.3 mg/kg LY3015014 administered IV. | 6 |
| 1.0 mg/kg LY3015014 IV A single dose of 1.0 mg/kg LY3015014 administered IV. | 6 |
| 3.0 mg/kg LY3015014 IV A single dose of 3.0 mg/kg LY3015014 administered IV. | 6 |
| 3.0 mg/kg LY3015014 SC A single dose of 3.0 mg/kg LY3015014 administered SC. | 6 |
| 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. | 6 |
| 10.0 mg/kg LY3015014 IV A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants. | 10 |
| Placebo A single dose of placebo administered IV or SC with a statin add-on dose. | 17 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | 0.03 mg/kg LY3015014 IV | Total | Placebo | 10.0 mg/kg LY3015014 IV | 3.0 mg/kg LY3015014 SC +Statin | 3.0 mg/kg LY3015014 SC | 3.0 mg/kg LY3015014 IV | 1.0 mg/kg LY3015014 IV | 0.3 mg/kg LY3015014 IV | 0.1 mg/kg LY3015014 IV |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 8.6 | 49.1 years STANDARD_DEVIATION 12.1 | 48.5 years STANDARD_DEVIATION 12.8 | 52.5 years STANDARD_DEVIATION 12 | 53.3 years STANDARD_DEVIATION 4.1 | 44.3 years STANDARD_DEVIATION 14.1 | 51.7 years STANDARD_DEVIATION 13.9 | 50.2 years STANDARD_DEVIATION 14.6 | 46.3 years STANDARD_DEVIATION 17.5 | 47.3 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 6 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 63 Participants | 16 Participants | 8 Participants | 6 Participants | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 56 Participants | 14 Participants | 4 Participants | 4 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
| Region of Enrollment United States | 8 participants | 69 participants | 5 participants | 8 participants | 8 participants | 8 participants | 8 participants | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 23 Participants | 7 Participants | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 46 Participants | 10 Participants | 6 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 6 | 4 / 6 | 2 / 6 | 3 / 6 | 3 / 6 | 6 / 6 | 3 / 6 | 6 / 10 | 13 / 17 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 17 |
Outcome results
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.
Time frame: Baseline to study completion (up to 22 weeks)
Population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Effects | AE | 13 Participants |
| 0.03 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 0.03 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | AE | 4 Participants |
| 0.1 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 0.1 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | AE | 4 Participants |
| 0.3 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 0.3 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | AE | 2 Participants |
| 1.0 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 1.0 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | AE | 3 Participants |
| 3.0 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | AE | 3 Participants |
| 3.0 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 3.0 mg/kg LY3015014 SC | Number of Participants With Clinically Significant Effects | AE | 6 Participants |
| 3.0 mg/kg LY3015014 SC | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 3.0 mg/kg LY3015014 SC +Statin | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 3.0 mg/kg LY3015014 SC +Statin | Number of Participants With Clinically Significant Effects | AE | 3 Participants |
| 10.0 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | SAE | 0 Participants |
| 10.0 mg/kg LY3015014 IV | Number of Participants With Clinically Significant Effects | AE | 6 Participants |
Secondary
Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies
Time frame: Days 8, 29 and 85
Population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| Placebo | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| Placebo | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 0.03 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 0.03 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 0.03 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 0.1 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 0.1 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 0.1 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 0.3 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 0.3 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 0.3 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 1.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 1.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 1.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 3.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 3.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 3.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 3.0 mg/kg LY3015014 SC | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 3.0 mg/kg LY3015014 SC | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 3.0 mg/kg LY3015014 SC | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 3.0 mg/kg LY3015014 SC +Statin | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
| 3.0 mg/kg LY3015014 SC +Statin | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 3.0 mg/kg LY3015014 SC +Statin | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 10.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 8 | 0 Participants |
| 10.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 85 | 0 Participants |
| 10.0 mg/kg LY3015014 IV | Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies | Day 29 | 0 Participants |
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.
Time frame: Baseline, Days 15 and 29
Population: All randomized participants with evaluable LDL-C data at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -1.69 percentage of change |
| Placebo | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -2.88 percentage of change |
| 0.03 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -11.55 percentage of change |
| 0.03 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -6.17 percentage of change |
| 0.1 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -17.49 percentage of change |
| 0.1 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -13.01 percentage of change |
| 0.3 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -40.34 percentage of change |
| 0.3 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -31.83 percentage of change |
| 1.0 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -34.90 percentage of change |
| 1.0 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -34.84 percentage of change |
| 3.0 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -54.40 percentage of change |
| 3.0 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -57.00 percentage of change |
| 3.0 mg/kg LY3015014 SC | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -51.63 percentage of change |
| 3.0 mg/kg LY3015014 SC | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -53.56 percentage of change |
| 3.0 mg/kg LY3015014 SC +Statin | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -56.58 percentage of change |
| 3.0 mg/kg LY3015014 SC +Statin | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -58.02 percentage of change |
| 10.0 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -47.31 percentage of change |
| 10.0 mg/kg LY3015014 IV | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -39.31 percentage of change |
| 10.0 mg/kg LY3015014 IV Non-Japanese | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 15 | -50.83 percentage of change |
| 10.0 mg/kg LY3015014 IV Non-Japanese | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Day 29 | -58.08 percentage of change |
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)]
Time frame: 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
Population: All randomized participants who received LY3015014 and had PK data to calculate AUC(0-tlast).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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)] | 109 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 9 |
| 0.03 mg/kg LY3015014 IV | 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)] | 435 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 16 |
| 0.1 mg/kg LY3015014 IV | 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)] | 1450 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 20 |
| 0.3 mg/kg LY3015014 IV | 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)] | 5610 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 22 |
| 1.0 mg/kg LY3015014 IV | 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)] | 18600 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 17 |
| 3.0 mg/kg LY3015014 IV | 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)] | 89100 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 17 |
| 3.0 mg/kg LY3015014 SC | 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)] | 57500 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 62 |
| 3.0 mg/kg LY3015014 SC +Statin | 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)] | 12700 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 39 |
| 10.0 mg/kg LY3015014 IV | 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)] | 11700 micrograms *hour/milliliter (µg*h/mL) | Geometric Coefficient of Variation 32 |
Secondary
PK: Maximum Concentration (Cmax) of LY3015014
Time frame: 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
Population: All randomized participants who received LY3015014 and had PK data to calculate Cmax.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PK: Maximum Concentration (Cmax) of LY3015014 | 1.18 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 16 |
| 0.03 mg/kg LY3015014 IV | PK: Maximum Concentration (Cmax) of LY3015014 | 3.18 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 7 |
| 0.1 mg/kg LY3015014 IV | PK: Maximum Concentration (Cmax) of LY3015014 | 11.0 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 18 |
| 0.3 mg/kg LY3015014 IV | PK: Maximum Concentration (Cmax) of LY3015014 | 29.2 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 21 |
| 1.0 mg/kg LY3015014 IV | PK: Maximum Concentration (Cmax) of LY3015014 | 97.3 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 27 |
| 3.0 mg/kg LY3015014 IV | PK: Maximum Concentration (Cmax) of LY3015014 | 312 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 18 |
| 3.0 mg/kg LY3015014 SC | PK: Maximum Concentration (Cmax) of LY3015014 | 282 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 9 |
| 3.0 mg/kg LY3015014 SC +Statin | PK: Maximum Concentration (Cmax) of LY3015014 | 24.8 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 25 |
| 10.0 mg/kg LY3015014 IV | PK: Maximum Concentration (Cmax) of LY3015014 | 19.8 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 24 |