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| ID | Type | Description | Link |
|---|---|---|---|
| J3H-MC-GZNJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3549492 (Treatment Group 1) | Experimental | LY3549492 administered orally. |
|
| LY3549492 (Treatment Group 2) | Experimental | LY3549492 administered orally. |
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| LY3549492 (Treatment Group 3) | Experimental | LY3549492 administered orally. |
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| LY3549492 (Treatment Group 4) | Experimental | LY3549492 administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3549492 | Drug | Administered orally |
|
| 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 | Baseline through end of the Follow-up Period (Week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492 | PK: Cmax of LY3549492 | Predose on Day 1 through end of the Follow-up Period (Week 10) |
| PK: Observed Drug Trough Concentration (Ctrough) of LY3549492 |
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Inclusion Criteria:
Exclusion Criteria:
Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader Willi syndrome.
Have any of the following conditions at screening,
Have had any of the following within 6-months prior to screening
Have serum triglyceride of 5 millimoles per liter (mmol/L) or greater (442 milligrams per deciliter [mg/dL]) at screening
Have had any exposure to glucagon-like peptide-1 (GLP-1) analogs or other related compounds within the 3 months prior to screening
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| 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 | Daytona Beach | Florida | 32117 | United States | ||
| Fortrea Clinical Research Unit |
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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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PK: Ctrough of LY3549492
| Predose on Day 1 through end of the Follow-up Period (Week 10) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492 | PK: AUC of LY3549492 | Predose on Day 1 through end of the Follow-up Period (Week 10) |
| Dallas |
| Texas |
| 75247 |
| United States |
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |