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| ID | Type | Description | Link |
|---|---|---|---|
| J6W-MC-YMAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to understand how safe and well-tolerated LY4174794 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4174794 gets into the bloodstream and how long it takes the body to eliminate it.
Participation in this study will last about 35 to 45 weeks (7 to 11 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY4174794 | Experimental | Participants will receive LY4174794 administered subcutaneously (SC). |
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| Part B: LY4174794 | Experimental | Participants will receive LY4174794 administered SC. |
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| Part A & B: Placebo | Placebo Comparator | Participants will receive placebo administered SC. |
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| Part C: LY4174794 | Experimental | Participants will receive LY4174794 administered intravenously (IV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4174794 | Drug | Administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and C: 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 | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through end of the Follow-up (Week 25) |
| Part B: Number of Participants with One or More TEAEs and SAEs Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through end of the Follow-up (Week 39) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and C: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 25) | |
| Part A and C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 25) |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78232 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| LY4174794 |
| Drug |
Administered IV. |
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| Placebo | Drug | Administered SC. |
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| Part B: PK: Maximum Observed Drug Concentration (Cmax) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 39) |
| Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4174794 | Predose on day 1 through end of the Follow-up Period (Week 39) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |