Clinical trial NCT06333977: A Study of LC542019 in Healthy Subjects and Subjects With T2DM
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Diabetes Mellitus, Type 2
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Incidence, severity of adverse events
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Maximum Concentration (Cmax) in Plasma
timeFrame: up to 4 weeks
measure: Renal Clearance (CLR) in urine
timeFrame: up to 2 weeks
Other outcomes:
measure: Cardiodynamic evaluation
timeFrame: up to 4 weeks
measure: Fasting Plasma Glucose
timeFrame: up to 4 weeks
measure: HbA1c
timeFrame: up to 4 weeks
Locations:
city: Las Vegas
country: United States
facility: PPD Development, LP (PPD Clinical Research Unit, Las Vegas)
state: Nevada
Study officials:
References: