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| ID | Type | Description | Link |
|---|---|---|---|
| J4O-MC-EZHA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3971297 (Part A) | Experimental | Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants |
|
| LY3971297 (Part B) | Experimental | Multiple ascending doses of LY3971297 administered SC in healthy participants |
|
| LY3971297 (Part C) | Experimental | Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants |
|
| LY3971297 (Part D) | Experimental | Multiple ascending doses of LY3971297 administered SC |
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| LY3971297 (Part E) | Experimental | Multiple doses of LY3971297 administered SC in healthy Japanese participants |
|
| Placebo (Part A, B, C, D, E, & G) | Placebo Comparator | Placebo administered SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3971297 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and F: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline (Day of Exposure) to Day 29 post-dose |
| Part B, C, D, E, & G: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Part B, C, D, E, & G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline (Day of Exposure) to Day 57 post-dose |
| Part F: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297 | Part F: PK: AUC of LY3971297 | Baseline Up to Day 29 post-dose for Part F |
| Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297 | Part F: PK: Cmax of LY3971297 | Baseline Up to Day 29 post-dose for Part F |
| Measure | Description | Time Frame |
|---|---|---|
| Part B, C, D, E, and G: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297 | Part B, C, D, E, and G: PK: AUC of LY3971297 | Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G |
| Part B, C, D, E, and G: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT | Completed | Anaheim | California | 92801 | United States | |
| Clinical Pharmacology of Miami |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| LY3971297 (Part F) | Experimental | Single doses of LY3971297 administered intravenously (IV) in healthy participants |
|
| LY3971297 (Part G) | Experimental | Multiple doses of LY3971297 administered SC |
|
| Placebo | Drug | Administered SC |
|
| LY3971297 IV | Drug | Administered IV |
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Part B, C, D, E, and G: PK: Cmax of LY3971297 |
| Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G |
| Recruiting |
| Miami |
| Florida |
| 33172 |
| United States |
|
| ICON Early Phase Services | Completed | San Antonio | Texas | 78209 | United States |
| Hakata Clinic | Active, not recruiting | Fukuoka | 812-0025 | Japan |
| P-One Clinic | Active, not recruiting | HachiĆji | 192-0071 | Japan |
| Clinical Research Hospital Tokyo | Active, not recruiting | Shinjuku-ku | 160-0004 | Japan |
| Lilly Centre for Clinical Pharmacology | Completed | Singapore | 138623 | Singapore |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |