Diabetes Mellitus, Type 2
Conditions
Brief 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.
Interventions
DRUGLY3305677
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through 24 weeks | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677 | Baseline through 48 hours postdose | PK: Cmax of LY3305677 |
| PK: Area Under the Concentration-Time Curve (AUC) of LY3305677 | Baseline through 48 hours postdose | PK: AUC of LY3305677 |
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | Baseline, through Week 16 | PD: Change from Baseline in Fasting Plasma Glucose |
| PD: Change from Baseline in Fasting Plasma Insulin | Baseline, through Week 16 | PD: Change from Baseline in Fasting Plasma Insulin |
Countries
Germany
Outcome results
None listed