a study of ly3457263 in healthy participants and participants with type 2 diabetes

Conditions: Healthy; Type 2 Diabetes

Summary: the main purpose of this study is to investigate the safety and tolerability of the study drug ly3457263 in healthy participants and 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 has two parts (part a and b). each part will last up to 10 weeks and may include up to either 13 (part a) or 19 (part b) visits.


Eligibility criteria:
inclusion criteria: * males that agree to use an effective method of contraception or agree to remain abstinent * females that are not of childbearing potential due to postmenopausal status or due to surgical sterility * part a only: * are overtly healthy * body mass index (bmi) of 18.5 to 35 kilograms per meter squared (kg/m²) * part b only: * have been diagnosed with type 2 diabetes (t2d) for at least 6 months prior to screening * be treated for t2d with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (dpp-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (glp-1) receptor agonist with or without metformin for at least 3 months prior to screening * bmi of 27 to 40 kg/m² exclusion criteria: * have undergone any form of bariatric surgery * have used or intend to use medications that promote weight loss within 3 months prior to screening, for the duration of the study * part a only: * have fasting plasma glucose (pg) levels ≥7 millimoles per liter (mmol/l) (≥126 milligrams per deciliter (mg/dl)) at screening * have hemoglobin a1c (hba1c) level ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening * have serum aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>20% and 10%, above the upper limit of normal (uln), respectively. elevation of total bilirubin level is considered acceptable in case of gilbert's disease (with a normal direct bilirubin) * part b only: * have type 1 diabetes 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 known proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy * present comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) unless they are well-controlled with stable medication * have had an episode of severe hypoglycaemia within 6 months prior to screening, or have a history of hypoglycaemia unawareness or poor recognition of hypoglycaemia * have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase \>2 × uln at screening * have a resting heart rate of \ 100 beats per minute * have an estimated glomerular filtration rate (\<60 milliliter/minute (ml/min)/1.73 m2, or a level of estimated glomerular filtration rate that would contraindicate the use of metformin per the label in the respective country * have a screening calcitonin ≥20.0 picograms per milliliter (pg/ml) * fasting serum triglyceride level of \>500 mg/dl at screening * have serum ast or alt \>3 × uln or tbl \>1.5 × uln (except for participants diagnosed with gilbert's syndrome) * have taken any prescription medication that are specifically indicated for lowering serum triglycerides within the last 3 months * have taken within the last 3 months any medications that interfere with absorption of dietary cholesterol or fats * use of medications known to prolong the qt/qtc interval * treated only with diet and exercise at study entry