Could a single pill replace three diabetes drugs? early study begins
NCT ID NCT07548957
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes mellitus type 2 are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a nurse and a neighbor help tame chronic disease?
- Which SGLT2 inhibitor wins? trial pits empagliflozin against dapagliflozin
- Can a vegan diet shield police officers from heart disease?
- Can a health coach in your patient portal help you lose weight?
- Common antibiotic may boost diabetes control
- Can continuous glucose monitors safely tighten hospital blood sugar control?