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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003257-31 | EudraCT Number | ||
| J2V-MC-GZLB | 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 LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3532226 + Dulaglutide (Part A) | Experimental | LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC. |
|
| Placebo + Dulaglutide (Part A) | Placebo Comparator | Placebo administered SC followed by dulaglutide administered SC. |
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| Dulaglutide + Placebo (Part B) | Active Comparator | Dulaglutide administered SC in combination with placebo given SC. |
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| LY3532226 + Dulaglutide (Part B) | Experimental | LY3532226 administered SC in combination with Dulaglutide given SC. |
|
| LY3532226 + Placebo (Part B) | Experimental | LY3532226 administered SC in combination with placebo given SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3532226 | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Week 16 |
| Part B: Change from Baseline in Total Clamp Disposition Index (cDI) | Change from Baseline in Total cDI | Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226 | PK: Cmax of LY3532226 | Predose on Day 1 through Week 16 |
| Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226 |
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Inclusion Criteria:
Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
Have the following glycosylated hemoglobin (HbA1c) levels at screening:
Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
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 |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | 41460 | Germany |
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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 |
|---|---|
| C555680 | dulaglutide |
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| Placebo | Drug | Administered SC. |
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| Dulaglutide | Drug | Administered SC. |
|
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PK: AUC of LY3532226
| Predose on Day 1 through Week 16 |
| Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp | Change from Baseline in ISR from hyperglycaemic clamp | Baseline through Week 12 |
| Part B: Change from Baseline in β-cell Glucose Sensitivity (GS) from hyperglycaemic clamp | Change from Baseline in β-cell GS from hyperglycaemic clamp | Baseline through Week 12 |
| Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value | Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value | Baseline through Week 12 |
| Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT) | Change from Baseline in Fasting and Post meal Glucose during sMMTT | Baseline through Week 16 |
| Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c) | Change from Baseline in HbA1c | Baseline through Week 16 |
| Part A & B: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT | Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT | Baseline through Week 16 |
| D004700 | Endocrine System Diseases |