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| ID | Type | Description | Link |
|---|---|---|---|
| I8P-MC-OXAD | Other Identifier | Eli Lilly and Company | |
| 2018-004779-11 | EudraCT Number |
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The main purpose of this study is to learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. The study will last about 20 weeks for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3305677 | Experimental | LY3305677 administered SC |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3305677 | Drug | Administered SC |
| |
| Placebo |
| 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 | 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 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677 | PK: Cmax of LY3305677 | Baseline through 48 hours postdose |
| PK: Area Under the Concentration-Time Curve (AUC) of LY3305677 |
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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 |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | North Rhine-Westphalia | 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 |
|---|---|
| C000719829 | mazdutide |
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| Drug |
Administered SC |
|
PK: AUC of LY3305677
| Baseline through 48 hours postdose |
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | PD: Change from Baseline in Fasting Plasma Glucose | Baseline, through Week 16 |
| PD: Change from Baseline in Fasting Plasma Insulin | PD: Change from Baseline in Fasting Plasma Insulin | Baseline, through Week 16 |
| D004700 | Endocrine System Diseases |