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New diabetes drug HM11260C aims to lower blood sugar in phase 3 trial

NCT ID NCT07379333

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This Phase 3 trial tests an experimental drug called HM11260C in adults with type 2 diabetes whose blood sugar is not well controlled with metformin and dapagliflozin. About 118 participants will receive either HM11260C or a placebo, and researchers will measure changes in HbA1c (a key blood sugar marker) over 36 weeks. The goal is to see if this new drug can safely improve blood sugar levels.

What this could mean

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

Active substance
HM11260C (an experimental drug for diabetes)
What this could lead to
If successful, this could provide a new treatment option for people with type 2 diabetes who need better blood sugar control.
What could go wrong
This is still an experimental drug in a relatively small Phase 3 trial. It may not prove more effective than existing treatments, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 118 people

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

Started

Apr 2026

Expected to finish

Jan 2028

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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\. Adults aged 19 years or older * 2\. Diagnosed with type 2 diabetes * 3\. HbA1c level 7.0% ≤ HbA1c ≤ 10.0% * 4\. Stable administration of metformin (≥1,000 mg/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1 * 5\. 20 kg/m2 ≤ BMI ≤ 45 kg/m2 * 6\. Agree to the recommended exercise and diet regimen during this clinical trial Exclusion Criteria: * 1\. Patients with a history of allergy or resistance to the investigational drug or background therapy * 2\. Patients diagnosed with a type of diabetes other than type 2 diabetes * 3\. Patients with uncontrolled severe diabetic complications * 4\. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis. * 5\. Patients with a history of diabetic coma or precoma * 6\. Those with a history of severe hypoglycemia * 7\. Those whose weight change \> 5 kg * 8\. History of gastrointestinal disease or surgery * 9\. History of bariatric surgery * 10\. History of gallbladder disease * 11\. History of a disease that could affect the interpretation of HbA1c * 12\. History of acute or chronic pancreatitis or pancreatectomy * 13\. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2). * 14\. Uncontrolled hypertension * 15\. Severe infections or severe trauma * 16\. Malnutrition, starvation, or debility, as determined by the investigator. * 17\. Pituitary or adrenal insufficiency. * 18\. Tissue hypoxia, such as respiratory failure or shock. * 19\. History of alcoholism or drug abuse * 20\. History of malignant tumors * 21\. Heart failure, Ischemic heart disease, Severe cerebrovascular disease, TIA * 22\. Patients with one of the following clinical laboratory test results : Amylase or Lipase \> 3 X ULN / FPG \> 270 mg/dL * 23\. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT \> 3 X ULN / Total bilirubin \> 1.5 X ULN * 24\. Patients with moderate or severe renal impairment * 25\. History of Diabetic medications or weight-loss medications * 26\. Those who have participated in another clinical trial and received investigational drugs within 30 days * 27\. Pregnant or lactating women, or women of childbearing potential * 28\. Women of childbearing potential and men who do not consent to the use of the following contraceptive methods * 29\. Considered by investigator as not appropriate to participate in the clinical study with other reason.

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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

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    RECRUITING

    Gyeonggi-do, South Korea

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