A Study of LC542019 in Healthy Subjects and Subjects With T2DM

NCT06333977 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-GQCL001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence, severity of adverse events

  up to 4 weeks

Secondary Outcomes (2)

• Maximum Concentration (Cmax) in Plasma

  up to 4 weeks

• Renal Clearance (CLR) in urine

  up to 2 weeks

Other Outcomes (3)

• Cardiodynamic evaluation

  up to 4 weeks

• Fasting Plasma Glucose

  up to 4 weeks

• HbA1c

  up to 4 weeks

Study Arms (2)

LC542019

EXPERIMENTAL

oral dose, once daily.

Drug: LC542019

Placebo

PLACEBO COMPARATOR

matching placebo capsules.

Drug: Placebo

Interventions

LC542019 DRUG

oral dose, once daily

LC542019

Placebo DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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)

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

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

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: March 27, 2024
• Study Start: March 25, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)