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Will breakfast change how this diabetes drug works?

NCT ID NCT07396844

Knowledge-focused Sponsor: LG Chem Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This early-stage trial in 28 healthy adults tests whether eating a meal changes how the body absorbs a single tablet containing three diabetes medicines (gemigliptin, dapagliflozin, and metformin). Participants take the pill once while fasting and once after a meal, and researchers measure drug levels in the blood. The goal is to understand food effects, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gemigliptin/Dapagliflozin/Metformin fixed-dose combination tablet
What this could lead to
If successful, this study could show that taking this combination diabetes pill with or without food is safe and absorbed similarly, guiding future dosing instructions.
What could go wrong
This is a very early Phase 1 study in only 28 healthy people, not patients. It only measures drug levels, not effectiveness or long-term safety. Results may not apply to people with diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

28 people

The number who actually took part.

Started

Jun 2026

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy Thai male and female subjects between the ages of 18 to 55 years. 2. Body mass index between 18.5 to 30.0 kg/m2. 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. 4. Non-pregnant woman and not currently breast feeding. 5. Female subjects abstain from either hormonal method of contraception or hormone replacement therapy. 6. Male subjects who are willing or able to use effective contraceptive. 7. Have voluntarily given written informed consent by the subject prior to participating in this study. Exclusion Criteria: 1. History of allergic reaction or hypersensitivity to gemigliptin or dapagliflozin or metformin. 2. History of evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, neurologic, allergic disease, or any significant ongoing chronic medical illness. 3. History of evidence of diabetic ketoacidosis. 4. History of evidence of genital infections, urinary tract infections within 14 days prior to check-in. 5. Have a eGFR (CKD-EPI) \< 60 mL/min/1.73 m2. 6. History or evidence of alcoholism or harmful use of alcohol within 2 years prior to screening. 7. Participated in other clinical trial within 90 days prior to check-in.

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Conditions

The condition(s) this trial relates to.

Fasting fish eye disease Lecithin Cholesterol Acyltransferase Deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fasting FED Healthy

Contacts and locations

Locations

  • Siriraj Hospital

    Nakhon Pathom, 73170, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.