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Type 2 Diabetes Mellitus (T2DM)Phase 1NCT07533539

Phase I Study to Evaluate the Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 in Healthy Volunteers

A Phase 1 study testing L03RD1, L03RD2 and L03TD1 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 L03TD1 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 L03TD1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
9 May 2026to 16 Jun 2026
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) Subjects who have a BMI between 18.0 and 29.9 kg/m², inclusive, at the time of screening (Body weight ≥50 kg for males, ≥45 kg for females).
  • 3) Subjects who have a seated blood pressure at the time of screening between 90 and 139 mmHg systolic and between 60 and 89 mmHg diastolic, inclusive.
  • 4) Subjects who do not have clinically significant congenital or chronic diseases and do not have pathological symptoms or findings as a result of internal medical examination. (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography, etc.)
  • 5) Subjects who are determined by the principal investigator(or the delegated investigator) to be suitable as a study subject based on the results of assessments performed during screening, such as diagnostic tests(e.g., hematology test, blood chemistry test, serology test, urinalysis) and electrocardiogram(ECG) conducted in accordance with the characteristics of the investigational product.
  • 6) Subjects or their spouse or partner agree to use a highly effective contraceptive methods* (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.
  • Highly effective contraceptive methods: intrauterine device (IUD), bilateral tubal occlusion, vasectomised partner, and sexual abstinence. However, periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Furthermore, the simultaneous use of a female condom and a male condom is not permitted.
  • 7) Subjects who have voluntarily decided to participate and have signed the informed consent form after receiving sufficient explanation and understanding of the purpose and content of the study, the characteristics of the investigational product, and the expected adverse events.

Who cannot join

  • 1) Subjects who have taken any drug that induces or inhibits drug metabolizing enzymes (e.g. barbiturates) within 1 month prior to the start of the study (date of first administration), or any drug that may affect this study within 10 days prior to the start of the study (date of first administration). (However, based on pharmacokinetic and pharmacodynamic characteristics such as drug interactions with the investigational product or the half-life of concomitant medications, the principal investigator (or the delegated investigator) will determine the subject's eligibility for participation)
  • 2) Subjects who participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to first administration of investigational product.
  • 3) Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a transfusion within 4 weeks prior to first administration of investigational product.
  • 4) Subject who have 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 first administration of investigational product
  • a. Excessive alcohol consumption
Show all 23Show fewer
  • More than 21 units/week for males
  • More than 14 units/week for females
  • (1 unit: 50 mL soju, 30 mL whiskey, or 250 mL beer)
  • b. Smoking more than 20 cigarettes per day
  • 6) Subjects who have 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) Subjects who have a history of clinically significant mental illness.
  • 8) Subjects who are 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) Female subjects 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 Evaluatethe Pharmacokinetics and Safety After Co-administration of L03RD1 and L03RD2 or Administration of L03TD1 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 L03TD1 in healthy volunteers.

Being tested
L03RD1, L03RD2, L03TD1
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

  • L03TD1Drug

    1 tablet of L03TD1

Study groups in NCT07533539
Study groupRoleWhat they receive
A (L03RD1/L03RD2 -> L03TD1)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 L03TD1
Receives: Drug: L03RD1; Drug: L03RD2; Drug: L03TD1
B (L03TD1 -> L03RD1/L03RD2)ExperimentalAdministration of 1 table of L03TD1, 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: L03TD1

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 posted16 Apr 2026
  2. Study start9 May 2026
  3. Primary completion28 May 2026
  4. Study completion16 Jun 2026

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533539
Sponsor's protocol ID
CT-L03-102
Status last verified
Jul 2026
First submitted
10 Apr 2026
Last updated
28 Jul 2026
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 L03TD1 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 8 inclusion and 23 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 28 Jul 2026. 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 NCT07533539.

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 28 Jul 2026.

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