A Study of LC542019 in Healthy Subjects and Subjects With... | NCT06333977

Studies
A Study of LC542019 in Healthy Subjects and Subjects With T2DM

NCT06333977

Sponsor

LG Chem

Status

Completed

Last Update Posted

Mar 27, 2024Actual

Enrollment

100Actual

Phase

Phase 1

Conditions

Healthy
Diabetes Mellitus, Type 2

Interventions

LC542019
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 25, 2022Actual

Primary Completion Date

Dec 14, 2023Actual

Completion Date

Dec 14, 2023Actual

First Submitted Date

Jul 31, 2023

First Submission Date that Met QC Criteria

Mar 20, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2024

Last Update Posted Date

Mar 27, 2024Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
LC542019	Experimental	oral dose, once daily.	Drug: LC542019
Placebo	Placebo Comparator	matching placebo capsules.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LC542019	Drug	oral dose, once daily	LC542019
Placebo

Measure	Description	Time Frame
Incidence, severity of adverse events		up to 4 weeks

Measure	Description	Time Frame
Maximum Concentration (Cmax) in Plasma		up to 4 weeks
Renal Clearance (CLR) in urine		up to 2 weeks

Measure	Description	Time Frame
Cardiodynamic evaluation	concentration-QTc analysis	up to 4 weeks
Fasting Plasma Glucose		up to 4 weeks

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases