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| ID | Type | Description | Link |
|---|---|---|---|
| I7D-FW-SGAA | 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 LY3108743 in healthy participants and in participants with type 2 diabetes.
The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.
The study will have up to 3 parts. Participants may enroll in only one part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Healthy | Placebo Comparator | Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. |
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| LY3108743 - Healthy | Experimental | Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. |
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| Placebo - Diabetes | Placebo Comparator | Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. |
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| LY3108743 - Diabetes | Experimental | Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. |
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| Placebo - Solution | Placebo Comparator | Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo - Capsule | 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 | Pre-dose up to Day 6 (5 days post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal | Baseline up to 24 hours | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743 | Baseline up to 48 hours |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | 117597 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| LY3108743 - Solution | Experimental | Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods. |
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| LY3108743 - Capsule |
| Drug |
Administered orally |
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| Placebo - Solution | Drug | Administered orally |
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| LY3108743 - Solution | Drug | Administered orally |
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| Pharmacokinetics: Area Under the Curve (AUC) of LY3108743 | Baseline up to 48 hours |
| Singapore |
| D004700 | Endocrine System Diseases |