NCT06333977CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2024
Brief summary (registry, in English)
to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 31 Jul 2023
- Start date
- 25 Mar 2022
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- LG Chem
- Diseases
- Type 2 diabetes
- NCT number
- NCT06333977
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 100
- From 25 Mar 2022 to the primary completion date, 14 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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:
- History of or current diagnosis of Diabetes Mellitus Type 1
- Current use of any prescribed or non-prescribed drugs (other than current treatment for diabetes mellitus or birth control methods)
Other
- 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
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- For healthy subjects:
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PPD Development, LP (PPD Clinical Research Unit, Las Vegas) Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.