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| ID | Type | Description | Link |
|---|---|---|---|
| J2L-MC-EZBB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the tolerability and safety of LY3461767 with any side effects that might be associated with it. Study drug will be provided in a continuous subcutaneous infusion lasting 24 hours to 96 hours, depending on the cohort. Blood tests will be performed to check concentrations of LY3461767 in the bloodstream and how long it takes the body to get rid of it in participants with chronic heart failure with reduced ejection fraction (HFrEF). The study will last up to 3 months and may include 5 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3461767 | Experimental | LY3461767 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously (SC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3461767 | Drug | Administered SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3461767 | PK: AUC of LY3461767 | Predose up to 48 hours post end of infusion |
| PK: Maximum Concentration (Cmax) of LY3461767 |
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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 |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States | ||
| Washington University |
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| Label | URL |
|---|---|
| A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
Administered SC. |
|
PK: Cmax of LY3461767
| Predose up to 48 hours post end of infusion |
| St Louis |
| Missouri |
| 63110 |
| United States |
| University of North Carolina, Division of Cardiology | Chapel Hill | North Carolina | 27599 | United States |
| Tsuchiura Kyodo Hospital | Tsuchiura | Ibaraki | 300-0053 | Japan |
| Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center | Kanazawa Ward,Yokohama | Kanagawa | 236-0051 | Japan |
| National Cerebral and Cardiovascular Center | Suita-shi | Osaka | 564-8565 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8655 | Japan |