A Study of LC542019 in Healthy Subjects and Subjects With T2DM

NCT ID: NCT06333977

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2023-12-14

Brief Summary

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

Detailed 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.

Conditions

Healthy; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LC542019

oral dose, once daily.

Group Type: EXPERIMENTAL

LC542019

Intervention Type: DRUG

oral dose, once daily

Placebo

matching placebo capsules.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo

Interventions

LC542019

oral dose, once daily

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• 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 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:

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Development, LP (PPD Clinical Research Unit, Las Vegas)

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

LG-GQCL001

Identifier Type: -

Identifier Source: org_study_id