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Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07158346

Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers

A Phase 1 study testing L03RD1, L03RD2 and CT-L03 in people with Type 2 Diabetes Mellitus (T2DM), run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the pharmacokinetics and safety after co-administration of L03RD1 and L03RD2 or administration of CT-L03 in healthy volunteers. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
L03RD1, L03RD2 and CT-L03
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteSouth Korea
Study dates
18 Aug 2025to 23 Oct 2025
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 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1) Subject is between 19 and 55 years of age, inclusive, at the time of screening.
  • 2) Subject has a BMI between 18.0 kg/m² and 29.9 kg/m², inclusive, at the time of screening (≥50 kg for males, ≥45 kg for females).
  • 3) Subject's seated blood pressure at the time of screening is 90-139mmHg (systolic) and 60-89 mmHg (diastolic), inclusive.
  • 4) Subject who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination. (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography, etc.)
  • 5) Subject who the principal investigator(or the delegated investigator) determines that he/she is suitable as a study subject as a result of tests performed during screening, such as diagnostic studies(e.g., hematology test, blood chemistry test, serology test, urinalysis) and electrocardiogram(ECG) set and conducted according to the characteristics of the investigational product.
  • 6) Subject or his or her spouse or partner agrees to use a medically recognized method of contraception* (excluding hormonal agents) to rule out the possibility of pregnancy from the date of first administration of the investigational product until 14 days after the last administration of the investigational product. They also agree not to donate sperm or eggs.
  • 7) Subject who after receiving sufficient explanation and understanding of the purpose, content, characteristics of the investigational product, and expected adverse events, have voluntarily decided to participate and provided written consent.

Who cannot join

  • 1) Subject who have taken a drug that induces or inhibits drug metabolizing enzymes (e.g. barbiturates) within 1 month before the start of the study(date of first administration), or if taken a drug that may affect this study within 10 days before the start of the study(date of first administration).
  • 2) Participated in another clinical trial or bioequivalence study and received an investigational product within 6 months of first dose of investigational product.
  • 3) Donated whole blood within 8 weeks, blood components within 2 weeks, or received a transfusion within 4 weeks of first dose of investigational product.
  • 4) Subject with a history of gastrointestinal resection that may affect drug absorption (excluding appendectomy and hernia surgery).
  • 5) Subjects who meet any of the following criteria within 1 month prior to the first dose
  • a. Excessive alcohol consumption
Show all 20Show fewer
  • b. Smoking more than 20 cigarettes per day
  • 6) Subjects with any of the following medical conditions
  • a. Known hypersensitivity to the active ingredient or any component of the investigational product
  • b. Heart failure or a history of heart failure
  • c. Active bladder cancer or history of bladder cancer
  • d. Hepatic impairment
  • e. Severe renal impairment
  • f. Uninvestigated macroscopic hematuria
  • g. Diabetic ketoacidosis, diabetic coma or pre-coma, Type 1 diabetes, or Type 2 diabetes
  • h. Severe infections, perioperative conditions, or moderate trauma
  • i. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • 7) Subject with a history of clinically significant mental illness.
  • 8) Subject who is judged by the principal investigator(or the delegated investigator) to be unsuitable for this clinical trial for reasons other than the above inclusion/exclusion criteria.
  • 9) For female subjects, those who are suspected of being pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • H plus Yangji Hostpital

    Seoul, 08756

Other trials in South Korea

About this study

Official title: A Randomized, Open, Single-dose, Crossover-design, Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of CT-L03 in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the pharmacokinetics and safety after co-administration of L03RD1 and L03RD2 or administration of CT-L03 in healthy volunteers.

Being tested
L03RD1, L03RD2, CT-L03
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.

  • L03RD1Drug

    1 tablet of L03RD1

  • L03RD2Drug

    2 tablets of L03RD2

  • CT-L03Drug

    1 tablet of CT-L03

Study groups in NCT07158346
Study groupRoleWhat they receive
A (L03RD1/L03RD2 -> CT-L03)ExperimentalAdministration of 1 tablet of L03RD1 and 2 tablets of L03RD2, and taking 14-day wash-out period, and then administration of 1 table of CT-L03
Receives: Drug: L03RD1; Drug: L03RD2; Drug: CT-L03
B (CT-L03 -> L03RD1/L03RD2)ExperimentalAdministration of 1 table of CT-L03, and taking 14-day wash-out period, and then administration of 1 tablet of L03RD1 and 2 tablets of L03RD2
Receives: Drug: L03RD1; Drug: L03RD2; Drug: CT-L03

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCt

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

  2. Cmax

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

Secondary outcomes (5)

  1. AUCinf

    Area under the plasma concentration-time curve from time 0 to infinity

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

  2. AUCt/AUCinf

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

  3. Tmax

    Time of peak plasma concentration

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

  4. t1/2

    Half-life

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

  5. CL/F

    Measured: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start18 Aug 2025
  3. Primary completion3 Oct 2025
  4. Study completion23 Oct 2025

Resources

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
Crossover
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158346
Sponsor's protocol ID
CT-L03-101
Status last verified
Nov 2025
First submitted
28 Aug 2025
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing L03RD1, L03RD2 and CT-L03 in people with Type 2 Diabetes Mellitus (T2DM), run by Celltrion at 1 site in South Korea.

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 7 inclusion and 20 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 21 Nov 2025. 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 South Korea. 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. 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?

AUCt (time frame: Pre-dose, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07158346.

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 21 Nov 2025.

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