- PlatoHealth
- Time Stamp: September 2, 20197:00 PM
- Source Node: 345812
Studies
Study First Submitted Date | 2019-08-08 |
Study First Posted Date | 2019-08-12 |
Last Update Posted Date | 2021-04-28 |
Start Month Year | September 3, 2019 |
Primary Completion Month Year | March 31, 2021 |
Verification Month Year | April 15, 2021 |
Verification Date | 2021-04-15 |
Last Update Posted Date | 2021-04-28 |
Facilities
Sequence: | 200322046 | Sequence: | 200322047 | Sequence: | 200322048 | Sequence: | 200322049 |
Name | WCCT Global | Name | Covance Clinical Research Inc | Name | Covance Dallas | Name | Covance Clinical Research Inc |
City | Cypress | City | Daytona Beach | City | Dallas | City | Madison |
State | California | State | Florida | State | Texas | State | Wisconsin |
Zip | 90630 | Zip | 32117 | Zip | 75247 | Zip | 53704 |
Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
Sequence: | 52236567 |
Name | Dyslipidemias |
Downcase Name | dyslipidemias |
Id Information
Sequence: | 40206407 | Sequence: | 40206408 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 17394 | Id Value | J1T-MC-GZEA |
Id Type | Other Identifier | ||
Id Type Description | Eli Lilly and Company | ||
Countries
Sequence: | 42620647 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55666844 | Sequence: | 55666845 | Sequence: | 55666846 | Sequence: | 55666847 |
Group Type | Experimental | Group Type | Placebo Comparator | Group Type | Experimental | Group Type | Placebo Comparator |
Title | LY3475766 – IV | Title | Placebo – IV | Title | LY3475766 – SC | Title | Placebo – SC |
Description | LY3475766 administered intravenously (IV) to participants with dyslipidemia | Description | Placebo administered IV to participants with dyslipidemia | Description | LY3475766 administered subcutaneously (SC) to participants with dyslipidemia | Description | Placebo administered SC to participants with dyslipidemia |
Interventions
Sequence: | 52550209 | Sequence: | 52550210 | Sequence: | 52550211 | Sequence: | 52550212 |
Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
Name | LY3475766 – IV | Name | LY3475766 – SC | Name | Placebo – IV | Name | Placebo – SC |
Description | Administered IV | Description | Administered SC | Description | Administered IV | Description | Administered SC |
Design Outcomes
Sequence: | 177617016 | Sequence: | 177617017 | Sequence: | 177617018 | Sequence: | 177617019 | Sequence: | 177617020 | Sequence: | 177617021 | Sequence: | 177617022 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Measure | Pharmaco*kinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766 | Measure | PK: Maximum Observed Drug Concentration (Cmax) of LY3475766 | Measure | PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766 | Measure | Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG) | Measure | PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Measure | PD: Percent Change from Baseline in Apolipoprotein B (ApoB) |
Time Frame | Baseline up to Day 85 | Time Frame | Predose up to Day 85 | Time Frame | Predose up to Day 85 | Time Frame | Predose up to Day 85 | Time Frame | Baseline, Day 85 | Time Frame | Baseline, Day 85 | Time Frame | Baseline, Day 85 |
Description | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Description | PK: AUC of LY3475766 | Description | PK: Cmax of LY3475766 | Description | PK: Tmax of LY3475766 | Description | PD: Percent Change from Baseline in TG | Description | PD: Percent Change from Baseline in LDL-C | Description | PD: Percent Change from Baseline in ApoB |
Browse Conditions
Sequence: | 193735901 | Sequence: | 193735902 | Sequence: | 193735903 |
Mesh Term | Dyslipidemias | Mesh Term | Lipid Metabolism Disorders | Mesh Term | Metabolic Diseases |
Downcase Mesh Term | dyslipidemias | Downcase Mesh Term | lipid metabolism disorders | Downcase Mesh Term | metabolic diseases |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 48380696 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Eli Lilly and Company |
Overall Officials
Sequence: | 29321107 |
Role | Study Director |
Name | 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) |
Affiliation | Eli Lilly and Company |
Design Group Interventions
Sequence: | 68237775 | Sequence: | 68237776 | Sequence: | 68237777 | Sequence: | 68237778 |
Design Group Id | 55666844 | Design Group Id | 55666846 | Design Group Id | 55666845 | Design Group Id | 55666847 |
Intervention Id | 52550209 | Intervention Id | 52550210 | Intervention Id | 52550211 | Intervention Id | 52550212 |
Eligibilities
Sequence: | 30803632 |
Gender | All |
Minimum Age | 18 Years |
Maximum Age | 65 Years |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria: Are overtly healthy males or females, apart from dyslipidemia Exclusion Criteria: Are taking or have started taking Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin >1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254021200 |
Number Of Facilities | 4 |
Registered In Calendar Year | 2019 |
Actual Duration | 19 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 18 |
Maximum Age Num | 65 |
Minimum Age Unit | Years |
Maximum Age Unit | Years |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30549643 |
Allocation | Randomized |
Intervention Model | Sequential Assignment |
Observational Model | |
Primary Purpose | Basic Science |
Time Perspective | |
Masking | Double |
Subject Masked | True |
Investigator Masked | True |
Responsible Parties
Sequence: | 28915990 |
Responsible Party Type | Sponsor |
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