Overview

A Study of LY3305677 in Participants With Type 2 Diabetes

Status:
Completed
Trial end date:
2021-07-08
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Criteria
Inclusion Criteria:

- Have Type II diabetes

- Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive

- Have a body weight of <150 kilograms (kg)

- Have clinical lab test results within normal reference range for the population or
investigator site, or results with acceptable deviations that are judged to be not
clinically significant by the investigator; however, should have serum magnesium and
potassium levels, along with lactate dehydrogenase, CK values within the normal range
at screening and Day -2.

Exclusion Criteria:

- Have Type 1 diabetes or latent autoimmune diabetes in adults

- Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state
requiring hospitalization for 6 months prior to screening

- Have had an episode of severe hypoglycemia, defined by the occurrence of
neuroglycopenic symptoms requiring the assistance of another person for recovery,
within 6 months prior to Visit 1

- Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in
the opinion of the investigator, increases the risks associated with participating in
the study or may confound ECG data analysis

- Have poorly controlled hypertension at screening; or a change in antihypertensive
medication within 30 days of screening

- Have an estimated glomerular filtration rate <45 milliliters per minute per 1.73
meters squared of body surface area (mL/min/1.73 m²)