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| ID | Type | Description | Link |
|---|---|---|---|
| J5L-MC-YHAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY4064912 (Cohorts 1-6) | Experimental | LY4064912 administered subcutaneously (SC) |
|
| Part A: LY4064912 (Cohort 6a) | Experimental | LY4064912 administered intravenously (IV) |
|
| Part A: Placebo | Placebo Comparator | Placebo administered SC and IV |
|
| Part B: LY4064912 (Cohorts 7-10) | Experimental | LY4064912 administered SC |
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| Part B: Placebo | Placebo Comparator | Placebo administered SC |
|
| Part C: LY4064912 (Cohort 11) | Experimental | LY4064912 administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4064912 | Drug | Administered SC |
|
| 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 regardless of causality, will be reported in the Reported Adverse Events module | Postdose to Approximately Week 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912 | PK: AUC of LY4064912 | Predose Up to Day 78 |
| PK: Maximum Concentration (Cmax) of LY4064912 | PK: Cmax of LY4064912 |
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Inclusion Criteria:
Part A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)
Part B: a BMI greater than or equal to 27 and less than 45 kg/m²
Part C: a BMI greater than or equal to 21 and less than 35 kg/m²
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 |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network - CNS | Recruiting | Los Alamitos | California | 90720 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Part C: Placebo | Experimental | Placebo administered SC |
|
| LY4064912 | Drug | Administered IV |
|
| Placebo | Drug | Administered SC |
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| Placebo | Drug | Administered IV |
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| Predose Up to Day 78 |
| Change from Baseline in Body Weight | Change from Baseline in Body Weight | Baseline to Approximately Week 27 |
| Effects of LY4064912 on Renal Hemodynamics and Renal Function | Glomerular Filtration Rate (GFR) | Baseline Up to Day 31 |
| ICON Early Phase Services | Recruiting | San Antonio | Texas | 78209 | United States |
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| Lilly Centre for Clinical Pharmacology | Recruiting | Singapore | 138623 | Singapore |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |