Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5S-EW-EFJD | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins. Following multiple doses of LY3015014, investigators will study the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body. Participants will remain in the study for about 3 months, not including screening. Screening is required within 28 days before the study starts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 milligrams per kilogram (mg/kg) of LY3015014 | Experimental | 1.0 mg/kg of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29). |
|
| Placebo | Placebo Comparator | 0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3015014 | Drug | Administered SQ |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs) | Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Baseline through study completion (Day 127) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014 | The Cmax was calculated after each dose of LY3015014. | Day 1 and 29: 4 hours (h) and 24 h postdose |
| PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Miramar | Florida |
Participants who discontinued from the study prior to completion were permitted to be replaced.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1.0 mg/kg of LY3015014 | LY3015014: 1.0 milligram per kilogram (mg/kg) of LY3015014 subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29). |
| FG001 | Placebo | Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1.0 mg/kg of LY3015014 | LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions (Q4W) (Days 1 and 29). |
| BG001 | Placebo | Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29). |
| 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 Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs) | Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | All enrolled participants. | Posted | Count of Participants | Participants | No | Baseline through study completion (Day 127) |
|
Baseline through Study Completion (Day 127)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.0 mg/kg of LY3015014 | LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000610655 | frovocimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Administered SQ |
|
The AUCt was calculated after each dose of LY3015014. |
| Day 1 and 29: 4 h and 24 h postdose |
| PK: Time of Maximum Concentration (Tmax) of LY3015014 | tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014. | Day 1 and 29: 4 h and 24 h postdose |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Percentage change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed model repeated measures (MMRM) analysis adjusted for baseline measurement. Treatment, day after dosing, and treatment-by-day interaction were included in the model. | Baseline, Day 43 and Day 57 |
| United States |
| BG002 | 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 | Count of Participants | Participants | No |
|
| Baseline Low Density Lipoprotein (LDL)-C | Mean | Standard Deviation | milligrams/deciliter (mg/dL) |
|
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014 | The Cmax was calculated after each dose of LY3015014. | Full analysis set (FAS): Data from all randomized participants who received at least 1 dose of the study drug according to the treatment the participants actually received and had evaluable PK data for Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Day 1 and 29: 4 hours (h) and 24 h postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014 | The AUCt was calculated after each dose of LY3015014. | FAS: Data from all randomized participants who received at least 1 dose of study drug according to the treatment the participants actually received and had evaluable PK data for AUCt. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter (µg*h/mL) | Day 1 and 29: 4 h and 24 h postdose |
|
|
|
| Secondary | PK: Time of Maximum Concentration (Tmax) of LY3015014 | tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014. | FAS: Data from all randomized participants who received at least 1 dose of study drug according to the treatment the participants actually received and had evaluable PK data for tmax. | Posted | Median | Full Range | days | Day 1 and 29: 4 h and 24 h postdose |
|
|
|
| Secondary | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) | Percentage change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed model repeated measures (MMRM) analysis adjusted for baseline measurement. Treatment, day after dosing, and treatment-by-day interaction were included in the model. | Pharmacodynamic analyses set: Participants who received at least 1 dose of investigational product according to the treatment actually received and had a baseline measurement and at least 1 post baseline measurement for LDL-C. | Posted | Least Squares Mean | 90% Confidence Interval | µg/mL | Baseline, Day 43 and Day 57 |
|
|
|
|
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Placebo | Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29). | 0 | 2 | 1 | 2 |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
|
|
| <0.001 |
P-value is for Day 57. |
| Mean Difference (Net) |
| -45.11 |
| 2-Sided |
| 90 |
| -65.91 |
| -24.31 |
| Superiority or Other |