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| ID | Type | Description | Link |
|---|---|---|---|
| J4P-MC-IYAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3938577 (Part A) | Experimental | LY3938577 administered Subcutaneously (SC). |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC. |
|
| Insulin degludec (Part A) | Active Comparator | Insulin degludec administered SC. |
|
| LY3938577 (Part B) | Experimental | LY3938577 administered SC. |
|
| Insulin degludec (Part B) | Active Comparator | Insulin degludec administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3938577 | Drug | Administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to 16 days |
| Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration | A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to 44 days |
| Part A: Incidence of Hypoglycemia | Baseline up to 16 days | |
| Part B: Incidence of Hypoglycemia | Baseline up to 44 days | |
| Part A: Number of Participants With Clinically Significant Changes in Vital Signs | Baseline up to 16 days | |
| Part B: Number of Participants With Clinically Significant Changes in Vital Signs | Baseline up to 44 days | |
| Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters | Baseline up to 16 days | |
| Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) | Part A: Predose up to 16 Days and Part B: Predose up to 44 Days |
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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 |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States | ||
| Qps-Mra, Llc |
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| Label | URL |
|---|---|
| A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus | View source |
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| Placebo |
| Drug |
Administered SC. |
|
| Insulin degludec | Drug | Administered SC. |
|
| Baseline up to 44 days |
| Miami |
| Florida |
| 33143 |
| United States |
| Labcorp CRU | Dallas | Texas | 75247 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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