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| ID | Type | Description | Link |
|---|---|---|---|
| I5S-EW-EFJB | Other Identifier | Eli Lilly and Company |
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This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple 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 participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks | Experimental | 1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days. |
|
| 1.0 mg/kg LY3015014 Every 4 Weeks | Experimental | 1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days. |
|
| 3.0 mg/kg LY3015014 Every 2 Weeks | Experimental | 3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days. |
|
| 3.0 mg/kg LY3015014 Every 4 Weeks | Experimental | 3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days. |
|
| Placebo Every 2 Weeks | Placebo Comparator | Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days. |
|
| Placebo Every 4 Weeks | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3015014 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs) | TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report. | Baseline through study completion (up to Day 127) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014 | The Cmax following the first dose and last dose of LY3015014 is reported. | First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose |
| PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau]) |
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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. | Honolulu | Hawaii | 96814 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.0 mg/kg LY3015014 Q2W | LY3015014: 1.0 milligrams per kilogram (mg/kg) given as subcutaneous (SC) injection every 2 weeks (Q2W) on Days 1, 15, and 29 for a total of 3 doses. |
| FG001 | 1.0 mg/kg LY3015014 Q4W | LY3015014: 1.0 mg/kg given as SC injection every 4 weeks (Q4W) on Days 1 and 29 for a total of 2 doses. |
| FG002 | 3.0 mg/kg LY3015014 Q2W | LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
| FG003 | 3.0 mg/kg LY3015014 Q4W | LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| FG004 | Placebo Q2W | Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
| FG005 | Placebo Q4W | Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least 1 dose of study drug (LY3015014 or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.0 mg/kg LY3015014 Q2W | LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
| BG001 | 1.0 mg/kg LY3015014 Q4W | LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| 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 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs) | TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report. | All enrolled participants who received at least 1 dose of study drug (LY3015014 or placebo). | Posted | Count of Participants | Participants | No | Baseline through study completion (up to Day 127) |
|
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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 | 1.0 mg/kg LY3015014 Q2W | LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.0 | 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 |
|---|---|
| C000610655 | frovocimab |
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Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days.
|
| Placebo | Other | Administered SC |
|
The AUC(0-tau) following the first dose and last dose of LY3015014 is reported. |
| First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose |
| PK: Time of Maximum Concentration (Tmax) of LY3015014 | The tmax following the first dose and last dose of LY3015014 is reported. | First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose |
| Percent Change From Baseline to Days 43, 57, and 127 in LDL-C | Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction. | Baseline, Day 43, Day 57, and Day 127 |
| 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 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | 3.0 mg/kg LY3015014 Q2W | LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
| BG003 | 3.0 mg/kg LY3015014 Q4W | LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| BG004 | Placebo Q2W | Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
| BG005 | Placebo Q4W | Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| OG002 | 3.0 mg/kg LY3015014 Q2W | LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. |
| OG003 | 3.0 mg/kg LY3015014 Q4W | LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. |
| OG004 | Placebo Q2W Plus Placebo Q4W | Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014 | The Cmax following the first dose and last dose of LY3015014 is reported. | All randomized participants who received at least 1 dose of LY3015014 and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau]) | The AUC(0-tau) following the first dose and last dose of LY3015014 is reported. | All randomized participants who received at least 1 dose of LY3015014 and had evaluable AUC(0-tau) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hours/milliliter (µg*h/mL) | First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose |
|
|
|
| Secondary | PK: Time of Maximum Concentration (Tmax) of LY3015014 | The tmax following the first dose and last dose of LY3015014 is reported. | All randomized participants who received at least 1 dose of LY3015014 and had evaluable tmax data. | Posted | Median | Full Range | days | First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose |
|
|
|
| Secondary | Percent Change From Baseline to Days 43, 57, and 127 in LDL-C | Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction. | Randomized participants who received at least 1 dose of study drug (LY3015014 or placebo) and had a baseline and at least 1 postbaseline measurement for LDL-C. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of change | Baseline, Day 43, Day 57, and Day 127 |
|
|
|
|
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | 1.0 mg/kg LY3015014 Q4W | LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. | 0 | 10 | 6 | 10 |
| EG002 | 3.0 mg/kg LY3015014 Q2W | LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. | 0 | 11 | 8 | 11 |
| EG003 | 3.0 mg/kg LY3015014 Q4W | LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. | 0 | 9 | 7 | 9 |
| EG004 | Placebo Q2W | Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses. | 0 | 5 | 3 | 5 |
| EG005 | Placebo Q4W | Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses. | 0 | 4 | 0 | 4 |
| Palpitations | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gingival swelling | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Application site irritation | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site rash | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Gingival infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| Menstruation delayed | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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|
| Last Dose |
|
|
|
| Last Dose |
|
|
|
| Last Dose |
|
|
| Day 57 |
|
| Day 127 |
|
P-value is for Day 57.
| <0.001 |
| Mean Difference (Net) |
| -34.85 |
| 90 |
| -48.78 |
| -20.93 |
| Superiority or Other |
| Mixed Effects Model Analysis | P-value is for Day 43. | <0.001 | Mean Difference (Net) | -47.72 | 90 | -62.10 | -33.34 | Superiority or Other |
| Mixed Effects Model Analysis | P-value is for Day 57. | <0.001 | Mean Difference (Net) | -32.26 | 90 | -46.69 | -17.82 | Superiority or Other |
| Mixed Effects Model Analysis | P-value is for Day 43. | <0.001 | Mean Difference (Net) | -45.36 | 90 | -60.07 | -30.64 | Superiority or Other |
| Mixed Effects Model Analysis | P-value is for Day 57. | <0.001 | Mean Difference (Net) | -32.04 | 90 | -46.76 | -17.32 | Superiority or Other |
| Mixed Effects Model Analysis | P-value is for Day 43. | <0.001 | Mean Difference (Net) | -46.80 | 90 | -61.12 | -32.49 | Superiority or Other |
| Mixed Effects Model Analysis | P-value is for Day 57. | <0.001 | Mean Difference (Net) | -44.64 | 90 | -58.95 | -30.32 | Superiority or Other |
| Mixed Effect Model Analysis | P-value is for Day 127 | 0.440 | Mean Difference (Net) | -6.53 | 90 | -20.51 | 7.44 | Superiority or Other |
| Mixed Effect Model Analysis | P-value is for Day 127. | 0.108 | Mean Difference (Net) | -14.10 | 90 | -28.53 | 0.33 | Superiority or Other |
| Mixed Effect Model Analysis | P-value is for Day 127. | 0.013 | Mean Difference (Net) | -22.41 | 90 | -37.13 | -7.69 | Superiority or Other |
| Mixed Effect Model Analysis | P-value is for Day 127. | 0.042 | Mean Difference (Net) | -17.93 | 90 | -32.42 | -3.44 | Superiority or Other |