HealthyPhase 1NCT06333977
A Study of LC542019 in Healthy Subjects and Subjects With T2DM
A Phase 1 study testing LC542019 in people with Healthy and Diabetes Mellitus, Type 2, run by LG Chem at 1 site in United States.
Trial summary
to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Diabetes Mellitus, Type 2
- What is being tested?
- LC542019
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2022to 14 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Development, LP (PPD Clinical Research Unit, Las Vegas)
Las Vegas, Nevada, 89113
About this study
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
to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM).
Read the 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.
- Conditions
- Healthy, Diabetes Mellitus, Type 2
- Being tested
- LC542019, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC542019Drug
oral dose, once daily
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| LC542019 | Experimental | oral dose, once daily. Receives: Drug: LC542019 |
| Placebo | Placebo comparator | matching placebo capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity of adverse events
Measured: up to 4 weeks
Secondary outcomes (2)
Maximum Concentration (Cmax) in Plasma
Measured: up to 4 weeks
Renal Clearance (CLR) in urine
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start25 Mar 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333977
- Sponsor's protocol ID
- LG-GQCL001
- Status last verified
- Mar 2024
- First submitted
- 31 Jul 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06333977
- Acronym / sponsor ID
- LG-GQCL001
- Conditions
- Healthy, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC542019 | Experimental | Drug: LC542019oral dose, once daily. |
| Placebo | Placebo comparator | Drug: Placebomatching placebo capsules. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
- History of or current diagnosis of Diabetes Mellitus Type 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC542019oral dose, once daily | Drug | LC542019 |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Incidence, severity of adverse events
Time frame: up to 4 weeks
2 secondary outcomes
Maximum Concentration (Cmax) in Plasma
Time frame: up to 4 weeks
Renal Clearance (CLR) in urine
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LC542019 in people with Healthy and Diabetes Mellitus, Type 2, run by LG Chem at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity of adverse events (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.