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| ID | Type | Description | Link |
|---|---|---|---|
| I8M-MC-BIXA | Other Identifier | Eli Lilly and Company | |
| 2016-003274-40 | EudraCT Number |
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The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3192767 (Part A) | Experimental | Escalating doses of LY3192767 administered subcutaneously (SC). |
|
| Placebo (Part A) | Placebo Comparator | Placebo matching LY3192767 administered subcutaneously (SC). |
|
| LY3192767 (Part B) | Experimental | LY3192767 administered as a SC injection in one of three study periods. |
|
| Basal Insulin Peglispro (Part B) | Active Comparator | Basal insulin peglispro administered as a SC injection in one of three study periods. |
|
| Insulin Glargine (Part B) | Active Comparator | Insulin glargine administered as a SC injection in one of three study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3192767 | Drug | Administered SC. |
| |
| 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 Study Completion (up to about Day 49) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767 | PK: Tmax of LY3192767 | Predose through 336 Hours |
| PK: Maximum Serum Concentration (Cmax) of LY3192767 | PK: Cmax of LY3192767 |
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Neuss | North Rhine-Westphalia | 41460 |
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| ID | Term |
|---|---|
| C000621851 | basal insulin peglispro |
| C587357 | LY2605541 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Basal Insulin Peglispro |
| Drug |
Administered SC. |
|
|
| Insulin Glargine | Drug | Administered SC. |
|
| Placebo | Drug | Administered SC. |
|
| Predose through 336 Hours |
| PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767 | PK: AUC(0-inf) of LY3192767 | Predose through 336 Hours |
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767 | PD: Total Amount of Glucose Infused (Gtot) of LY3192767 | Predose through 36 Hours During Clamp Procedure |
| PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767 | PD: Rmax of LY3192767 | Predose through 36 Hours During Clamp Procedure |
| PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767 | PD: TRmax of LY3192767 | Predose through 36 Hours During Clamp Procedure |
| PD: Change from Baseline in Free Fatty Acids | PD: Change from Baseline in Free Fatty Acids | Predose through 48 Hours Postdose |
| PD: Change from Baseline in Glycerol | PD: Change from Baseline in Glycerol | Predose through 48 Hours Postdose |
| PD: Change from Baseline in Triglycerides | PD: Change from Baseline in Triglycerides | Predose through 48 Hours Postdose |
| Germany |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |