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| ID | Type | Description | Link |
|---|---|---|---|
| J3S-MC-YEAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3541105 (Part A) | Experimental | Single ascending doses of LY3541105 administered subcutaneously (SC). |
|
| LY3541105 (Part B) | Experimental | Multiple ascending doses of LY3541105 administered SC. |
|
| LY3541105 (Part C) | Experimental | Escalating doses of LY3541105 administered SC. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC. |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC. |
|
| Placebo (Part C) | Placebo Comparator | Placebo administered SC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3541105 | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Predose up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105 | PK: AUC of LY3541105 | Predose through day 43 (Part A) & day 78 (Part B) |
| PK: Time of Maximum observed Concentration (Tmax) of LY3541105 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Lenexa | Kansas | 66219 | United States | ||
| ICON Early Phase Services |
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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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| Placebo | Drug | Administered SC. |
|
PK: Tmax of LY3541105
| Predose through day 43 (Part A) & day 78 (Part B) |
| PK: Maximum Observed Concentration (Cmax) of LY3541105 | PK: Cmax of LY3541105 | Predose through day 43 (Part A) & day 78 (Part B) |
| Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight | PD: Absolute and Percentage Change from Baseline in Body Weight | Predose through week 26 (Part B Only) |
| San Antonio |
| Texas |
| 78209 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |