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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Miami Research Associates
Miami, Florida, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
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
TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through final follow-up at Day 57
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Time frame: Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Maximum Observed Drug Concentration (Cmax) of LY3493269
Time frame: Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose
Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.
Time frame: Baseline, Day 29
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