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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBI | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3437943 + Drug Cocktail | Experimental | Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3437943 | Drug | Administered SC. |
| |
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam | PK: AUC[0-∞] of Midazolam | Predose up to 24 hours postdose |
| PK: Maximum Observed Concentration (Cmax) of Midazolam | PK: Cmax of Midazolam | Predose up to 24 hours postdose |
| PK: AUC[0-∞] of Warfarin | PK: AUC[0-∞] of Warfarin | Predose up to 96 hours postdose |
| PK: Cmax of Warfarin | PK: Cmax of Warfarin | Predose up to 96 hours postdose |
| PK: AUC[0-∞] of Caffeine | PK: AUC[0-∞] of Caffeine | Predose up to 48 hours postdose |
| PK: Cmax of Caffeine | PK: Cmax of Caffeine | Predose up to 48 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Covance Dallas |
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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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| ID | Term |
|---|---|
| C000729679 | retatrutide |
| D008874 | Midazolam |
| D014859 | Warfarin |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Administered orally. |
|
| Warfarin | Drug | Administered orally. |
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| Caffeine | Drug | Administered orally. |
|
| Dallas |
| Texas |
| 75247 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |