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| ID | Type | Description | Link |
|---|---|---|---|
| J6L-MC-YIAA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4167586 (Cohorts A1 to A6) | Experimental | LY4167586 administered subcutaneously (SC) |
|
| LY4167586 (Cohorts A1 to A6) Placebo | Placebo Comparator | LY4167586 administered SC |
|
| LY4167586 (Cohort B) | Experimental | LY4167586 administered intravenously (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4167586 | Drug | Administered SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Incidence of Serious Adverse Events (SAEs) | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline to study completion (up to 29 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) | PK: Cmax of LY4167586 | Predose on Day 1 through end of the Follow-up Period (Week 25) |
| PK: Time of Maximum Drug Concentration (tmax) |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Recruiting | Madison | Wisconsin | 53704 | 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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| Drug |
Administered SC |
|
| LY4167586 | Drug | Administered IV |
|
PK: tmax of LY4167586
| Predose on Day 1 through end of the Follow-up Period (Week 25) |
| PK: Area Under the Concentration Versus Time Curve (AUC) | PK: AUC of LY4167586 | Predose on Day 1 through end of the Follow-up Period (Week 25) |
| Lilly Centre for Clinical Pharmacology | Recruiting | Singapore | 138623 | Singapore |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |