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| ID | Type | Description | Link |
|---|---|---|---|
| J2V-MC-GZLD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period. Part C of the study will last approximately 8 weeks, excluding the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3532226 (Part A) | Experimental | LY3532226 administered subcutaneously (SC) |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC |
|
| LY3532226 (Part B) | Experimental | LY3532226 administered SC |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC |
|
| LY3532226 (Part C) | Experimental | LY3532226 administered SC |
|
| Placebo (Part C) | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3532226 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: 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 to Study Completion (Up to 16 Weeks) |
| Part B: 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 to Study Completion (Up to 20 Weeks) |
| Part 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 to Study Completion (Up to 8 Weeks)] |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226 | PK: Cmax of LY3532226 | Predose on Day 1 through Week 16 |
| Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226 |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Fortrea Clinical Research Unit |
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| Label | URL |
|---|---|
| Lilly Trials | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Administered SC |
|
PK: AUC of LY3532226
| Predose on Day 1 through Week 16 |
| Part B: PK: Cmax of LY3532226 | PK: Cmax of LY3532226 | Predose on Day 1 through Week 20 |
| Part B: PK: AUC of LY3532226 | PK: AUC of LY3532226 | Predose on Day 1 through Week 20 |
| Part C: Pharmacodynamic (PD): Change in insulin sensitivity index (Si) | Part C: PD: Change in Si | Baseline up to Approximately Week 4 |
| Dallas |
| Texas |
| 75247 |
| United States |
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |