A Study of LY3493269 in Participants With Type 2 Diabetes

• Status: Completed
• Trial end date: 2021-03-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide

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