A Study of LC542019 in Healthy Subjects and Subjects With T2DM

Phase 1

Completed

• Conditions: Healthy; Diabetes Mellitus, Type 2
• Interventions: Drug: LC542019; Drug: Placebo

• Registration Number: NCT06333977
• Lead Sponsor: LG Chem

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.

Study Timeline

• Study Start: 2022-03-25
• Study First Submitted: 2023-07-31
• Primary Completion: 2023-12-14
• Study Completion: 2023-12-14
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LC542019	LC542019	oral dose, once daily.
Placebo	Placebo	matching placebo capsules.

Primary Outcome Measures

Name	Time	Method
Incidence, severity of adverse events	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) in Plasma	up to 4 weeks
Renal Clearance (CLR) in urine	up to 2 weeks

Trial Locations

Locations (1)

PPD Development, LP (PPD Clinical Research Unit, Las Vegas); 🇺🇸 Las Vegas, Nevada, United States