A Study of LC542019 in Healthy Subjects and Subjects With T2DM

LG Chem

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: LC542019

Study type

Interventional

Funder types

Industry

Identifiers

NCT06333977

LG-GQCL001

Details and patient eligibility

About

to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).

Full description

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.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)