NCT06333977

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	LC542019	oral dose, once daily
DRUG	Placebo	matching placebo

Timeline

• Start date: 2022-03-25
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study