A Study of LC542019 in Healthy Subjects and Subjects With T2DM

A First in Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LC542019 in Healthy Subjects and Subjects With T2DM

to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (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)