A Study of LC542019 in Healthy Subjects and Subjects With T2DM

The study will be conducted in 2 parts:

Part 1 (Single Ascending Dose) This part will include 6 sequential dose cohorts (S1-S6).

Part 2 (Multiple Ascending Dose) This part will include 5 sequential dose cohorts (M1-M5). Cohorts M1-M4 will enroll healthy subjects. Cohort M5 will enroll subjects with T2DM.

For healthy subjects:

Inclusion criteria

• Adults ≥ 18 to ≤ 55 years.
• Body mass index (BMI) ≥18.5 to ≤ 30.0 kg/m2
• Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
• Ability to provide written informed consent.

Exclusion criteria

• History of or current diagnosis of Diabetes Mellitus Type 1 or Diabetes Mellitus Type 2
• History of or current significant diagnosis of cardiovascular, respiratory, hepatic, renal, gastrointestinal endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease
• History of or presence of clinically significant ECG findings
• History of or acute significant gastrointestinal disorder

For T2DM subjects:

Inclusion criteria

• Adults ≥ 18 to ≤ 70 years.
• Body mass index (BMI) ≥18.5 to ≤ 35.0 kg/m2 with stable body weight by history for 3 months
• Subjects with T2DM > 6 months, on stable therapy with metformin monotherapy.
• Female subjects must be non-pregnant and non-lactating. Females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening.
• Ability to provide written informed consent.

Exclusion criteria

• History of or current diagnosis of Diabetes Mellitus Type 1
• A subject who has acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, especially autonomic neuropathy
• Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
• Current use of any prescribed or non-prescribed drugs (other than current treatment for diabetes mellitus or birth control methods)