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| ID | Type | Description | Link |
|---|---|---|---|
| J5U-MC-YGAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.
Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 10 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY4086940 Single Dose (Healthy Participants) | Experimental | Participants will receive a single dose of LY4086940 orally |
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| Part A: Placebo Single Dose (Healthy Participants) | Placebo Comparator | Participants will receive a single dose of placebo orally |
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| Part A: LY4086940 Multiple Dose (Healthy Participants) | Experimental | Participants will receive LY4086940 orally for 3 days |
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| Part A: Placebo Multiple Dose (Healthy Participants) | Placebo Comparator | Participants will receive placebo orally for 3 days |
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| Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity) | Experimental | Participants will receive LY4086940 orally for 4 weeks |
|
| Part B: Placebo Multiple Dose (Participants with Overweight or Obesity) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4086940 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940 | Predose up to Day 64 | |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940 | Predose up to Day 64 |
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Inclusion Criteria:
Part A and Part E:
Part B:
Part C:
Part D:
Exclusion Criteria:
Parts A, B, C, E:
Part D:
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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 | ||
| Clinical Pharmacology of Miami |
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| Label | URL |
|---|---|
| A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes | View source |
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Participants will receive placebo orally for 4 weeks |
|
| Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity) | Experimental | Participants will receive LY4086940 orally for 4 weeks |
|
| Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity | Placebo Comparator | Participants will receive placebo orally for 4 weeks |
|
| Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) | Experimental | Participants will receive LY4086940 orally for 4-6 weeks |
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| Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) | Placebo Comparator | Participants will receive placebo orally for 4-6 weeks |
|
| Part E (Open-Label): LY4086940 Single Dose (Healthy Participants) | Experimental | Participants will receive a single dose of LY4086940 intravenously (IV) |
|
| Placebo | Drug | Administered orally |
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| LY4086940 | Drug | Administered IV |
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| Miami |
| Florida |
| 33172 |
| United States |
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D015431 | Weight Loss |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
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