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| ID | Type | Description | Link |
|---|---|---|---|
| I9K-MC-UCAA | Other Identifier | Eli Lilly and Company | |
| 2018-002337-38 | EudraCT Number |
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injection site reaction burden
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The purpose of this study is to investigate the safety of the study drug known as LY3322207. Participants must be healthy or must have hypertension (high blood pressure). Participants with hypertension may already be taking a common drug to reduce blood pressure called an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3322207 (Part A) | Experimental | LY3322207 administered subcutaneously (SC) |
|
| Placebo (Part A) | Placebo Comparator | Placebo matching LY3322207 administered SC |
|
| LY3322207 (Part B) | Experimental | LY3322207 administered SC once weekly |
|
| Placebo (Part B) | Placebo Comparator | Placebo matching LY3322207 administered SC once weekly |
|
| LY3322207 (Part C) | Experimental | LY3322207 administered SC in participants with hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3322207 | Drug | Administered by SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (Part A) | Serious and other non-serious adverse events will be reported in the Adverse Events Module | Baseline up to approximately 31 days |
| Number of Participants with One or More Serious Adverse Events (Part B) | Serious and other non-serious adverse events will be reported in the Adverse Events Module | Baseline up to approximately 9 weeks |
| Number of Participants with One or More Serious Adverse Events (Part C) | Serious and other non-serious adverse events will be reported in the Adverse Events Module | Baseline up to approximately 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A) | Pharmacokinetics (PK): AUC of LY3322207 | Predose up approximately 31 days |
| Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B) |
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Inclusion Criteria:
Healthy males, as determined by medical history and physical examination, must agree to use a medically appropriate method of birth control and agree not to donate sperm from start of dosing until 90 days beyond last dose
Healthy females, as determined by medical history and physical examination, of non-child bearing potential due to:
Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
Have a Body Mass Index (BMI) 18 to 30 kilogram per square meter (kg/m²) at entry
Have clinical laboratory test results within normal reference range for the population or site, or results with acceptable deviations that are judged not clinically significant
Be 18 to 55 years old for either Part A or Part B of the study, or 18 to 65 years old for Part C only
For Part C: must have been treated with a stable dose of ACE-I or ARB for at least 1 month
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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Part C will be open label
| Placebo | Drug | Administered by SC injection |
|
PK: AUC of LY3322207
| Predose up to approximately 9 weeks |
| Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C) | PK: AUC of LY3322207 | Predose up to approximately 9 weeks |
| Maximum Concentration (Cmax) of LY3322207 (Part A) | PK: Cmax of LY3322207 | Predose up approximately 31 days |
| Maximum Concentration (Cmax) of LY3322207 (Part B) | PK: Cmax of LY3322207 | Predose up to approximately 9 weeks |
| Maximum Concentration (Cmax) of LY3322207 (Part C) | PK: Cmax of LY3322207 | Predose up to approximately 9 weeks |
| Time to reach Cmax (Tmax) of LY3322207 (Part A) | PK: Tmax of LY3322207 | Predose up to approximately Day 31 |
| Time to reach Cmax (Tmax) of LY3322207 (Part B) | PK: Tmax of LY3322207 | Predose up to approximately 9 weeks |
| Time to reach Cmax (Tmax) of LY3322207 (Part C) | PK: Tmax of LY3322207 | Predose up to approximately 9 weeks |
| Change from Baseline in Systolic Blood Pressure (SBP) (Part A) | Supine position | Baseline up approximately 31 days |
| Change from Baseline in Systolic Blood Pressure (SBP) (Part B) | Supine position | Baseline up to approximately 9 weeks |
| Change from Baseline in Systolic Blood Pressure (SBP) (Part C) | Supine position | Baseline up to approximately 9 weeks |
| Change from Baseline in Diastolic Blood Pressure (DBP) (Part A) | Supine position | Baseline up approximately 31 days |
| Change from Baseline in Diastolic Blood Pressure (DBP) (Part B) | Supine position | Baseline up to approximately 9 weeks |
| Change from Baseline in Diastolic Blood Pressure (DBP) (Part C) | Supine position | Baseline up to approximately 9 weeks |
| Change from Baseline in Heart Rate (Part A) | Supine position | Baseline up approximately 31 days |
| Change from Baseline in Heart Rate (Part B) | Supine position | Baseline up to approximately 9 weeks |
| Change from Baseline in Heart Rate (Part C) | Supine position | Baseline up to approximately 9 weeks |