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| ID | Type | Description | Link |
|---|---|---|---|
| I8U-MC-DMBA | Other Identifier | Eli Lilly and Company |
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The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected.
It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Part A) | Placebo Comparator | Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A |
|
| LY3325656 (Part A) | Experimental | Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A |
|
| Placebo (Part B) | Placebo Comparator | Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B |
|
| LY3325656 (Part B) | Experimental | Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B |
|
| Liraglutide (Part B) | Active Comparator | Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B |
|
| LY3325656 + Sitagliptin (Part B) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3325656 | 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656 | Pharmacokinetics: Area Under the Concentration Curve of LY3325656 From Time Zero to 24 Hours [AUC(0-24)] | Baseline up to 72 hours after each dose of study drug |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656 |
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Inclusion Criteria:
For all participants:
For participants with Type 2 Diabetes Mellitus:
Exclusion Criteria:
For all participants:
For participants with Type 2 Diabetes Mellitus:
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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 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time 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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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Experimental |
Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B |
|
| Placebo | Drug | Administered orally |
|
| Liraglutide | Drug | Administered subcutaneously |
|
| Sitagliptin | Drug | Administered orally |
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656 |
| Baseline up to 72 hours after each dose of study drug |
| Singapore |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Singapore | Singapore |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |