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Could a single pill replace three diabetes drugs? early study begins

NCT ID NCT07548957

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new experimental pill called UI087, which combines three diabetes drugs into one. Researchers want to see if it is safe and how the body processes it compared to taking the three drugs separately. The study involves 44 healthy adults and is not yet testing the drug in people with diabetes.

What this could mean

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

Active substance
UI087 (a combination pill for type 2 diabetes)
What this could lead to
If successful, this could lead to a simpler, single-pill treatment for type 2 diabetes, replacing the need to take three separate drugs.
What could go wrong
This is a very early (Phase 1) study in healthy volunteers, not people with diabetes. It only checks safety and drug levels, not whether it actually works for diabetes. The results may not translate to patients.

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

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

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

19 years and older

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: * Subjects aged 19 years or older at the screening visit * Subjects with a body weight ≥ 50 kg (≥ 45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at the screening visit * BMI (kg/m²) = body weight (kg) / {height (m)}² * Subjects without clinically significant congenital or chronic diseases and without pathological symptoms or findings based on medical examination at the screening visit * Subjects deemed eligible for participation based on diagnostic tests (hematology, blood chemistry, serology, urinalysis, etc.) and ECG, as determined by the investigator (or delegated sub-investigator) according to the characteristics of the investigational product * Subjects who agree to use medically acceptable contraception\* (excluding hormonal methods) from the first dose until 7 weeks after the last dose of the investigational product, to prevent pregnancy for themselves or their spouse/partner, and who agree not to donate sperm or ova * Medically acceptable contraception: Use of intrauterine devices, vasectomy, tubal ligation, and/or barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or the use of spermicide in combination with at least two barrier methods * Subjects who voluntarily sign the informed consent form after receiving and fully understanding sufficient explanation regarding the purpose, procedures, characteristics of the investigational product, and expected adverse events of the clinical trial Exclusion Criteria: * Subjects with clinically significant diseases or a history of diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric/neurological, musculoskeletal, immune, ENT, dermatologic, or ophthalmologic systems * Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal diseases * Subjects who have taken enzyme-inducing or inhibiting drugs (e.g., barbiturates) within 1 month prior to the first dose, or medications that may affect the clinical trial within 10 days prior to the first dose (Participation may be allowed depending on pharmacokinetic/pharmacodynamic properties such as interactions and half- life) * Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first dose * Subjects who have donated whole blood within 8 weeks, donated blood components within 2 weeks, or received a transfusion within 4 weeks prior to the first dose * Subjects meeting the following conditions within 1 month prior to the first dose: * Alcohol consumption exceeding an average of 21 drinks/week for males * Alcohol consumption exceeding an average of 14 drinks/week for females (1 drink = 50 mL of soju, 30 mL of spirits, or 250 mL of beer) * Smoking more than an average of 20 cigarettes per day * Subjects who meet the following: * Hypersensitivity to the active ingredient, excipients of the investigational product, or a drug in the same class as the investigational product * Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Subjects with the following conditions: * Type 1 diabetes mellitus, lactic acidosis, or acute/chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), or a history of ketoacidosis * Moderate (stage 3b) or severe renal impairment (GFR \< 45 mL/min/1.73 m²), or acute conditions that may affect renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, or sepsis * Acute or unstable heart failure * Patients undergoing intravascular iodinated contrast imaging (e.g., intravenous urography, cholangiography, angiography, contrast-enhanced CT, etc.) * Diabetic pre-coma * Severe infections or severe traumatic systemic disorders * Patients scheduled for surgery * Patients with malnutrition, starvation, debility, hypopituitarism, or adrenal insufficiency * Patients with acute or chronic conditions that may cause tissue hypoxia (e.g., hepatic impairment, respiratory failure, acute myocardial infarction, shock) * Patients with excessive alcohol intake or gastrointestinal disorders such as dehydration, diarrhea, or vomiting * Subjects deemed unsuitable for participation by the investigator (or delegated sub-investigator) for any other reason not specified above * Female subjects who are pregnant, suspected to be pregnant, or breastfeeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • H plus Yangji Hospital

    Seoul, Gwanak-gu, 08779, South Korea

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