Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants with type 2 diabetes (T2D) at least 6 months before screening * Participants treated for T2D with diet and exercise, with or without metformin * Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5% * Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²) * Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Exclusion criteria
* Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs * Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young * Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy * Have known allergies to GLP-1 receptor agonists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Predose up to 16 weeks | A summary of TEAEs, 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 |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263 | Pre-dose on Day 1 up to 85 days post-dose | PK: AUC of LY3457263 |
Countries
United States
Outcome results
None listed