A Study of LY3493269 in Participants With Type 2 Diabetes
Study Details
Study Description
Brief Summary
The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3493269 LY3493269 administered Subcutaneous (SC). |
Drug: LY3493269
Administered SC
|
| Active Comparator: Dulaglutide Dulaglutide administered SC. |
Drug: Dulaglutide
Administered SC
Other Names:
|
| Placebo Comparator: Placebo Placebo administered SC. |
Drug: Placebo
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through final follow-up at Day 57]
A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269 [Baseline through final follow-up at Day 57]
PK: AUC of LY3493269
- PK: Maximum Concentration (Cmax) of LY3493269 [Baseline through final follow-up at Day 57]
PK: Cmax of LY3493269
- Pharmacodynamics (PD):Change from baseline to Day 29 in Fasting Glucose (FG) [Baseline, Day 29]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Are male or female not of childbearing potential
-
Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening
-
Have had a stable body weight (<5% body weight change) for the 3 months prior to screening
-
Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening
-
Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening
-
Have an HbA1c of at least 7.0% and no more than 10.5% at screening
-
Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator
Exclusion Criteria:
-
Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
-
Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
-
Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment
-
Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
-
Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea
-
Have a history of acute or chronic pancreatitis
-
Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
-
Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
| 2 | Miami Research Associates | Miami | Florida | United States | 33143 |
| 3 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17530
- J1X-MC-GZHC