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Experimental diabetes drug AP026 tested in early trial – but study halted

NCT ID NCT06143423

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a new drug called AP026, a fusion protein that targets two pathways (GLP-1 and FGF21) to potentially treat type 2 diabetes. The study planned to enroll 74 healthy adults but was terminated early after only 14 participants. The main goal was to check safety and how well the drug is tolerated.

What this could mean

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

Active substance
AP026 (a GLP-1-FGF21 fusion protein)
What this could lead to
If successful, this could lead to a new treatment option for type 2 diabetes that helps control blood sugar and weight.
What could go wrong
This was a very early (Phase 1) trial that was terminated early, so results are limited. The drug may not prove effective or safe in larger studies.

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

14 people

The number who actually took part.

Started

May 2023

Finished

Mar 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: * Sign an informed consent form before the study and have a thorough understanding of the content, process, and potential adverse reactions of the study; * Able to complete the study according to the requirements of the protocol; * Subjects (including their partners) are willing to voluntarily take effective contraceptive measures within 6 months after the last study drug administration; * Male and female subjects aged 18-55 (inclusive); * Male subjects weighing no less than 50 kilograms and female subjects weighing no less than 45 kilograms, With a body mass index within the range of 18\~28kg/m2 (inclusive); * Physical examination and vital signs are normal or abnormal but with no clinical significance (judged by the investigators). Exclusion Criteria: * Pregnant and lactating women; * There are abnormal and clinically significant clinical laboratory examination results, or clinically significant diseases within 12 months before screening, which is not recommended to participate in the trial after evaluation by the investigators. Subjects with a previous medical history but are recovered with clinical evidence can be included in this study; * During the screening period, any one of the vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, and other auxiliary examination results is abnormal and judged by the investigator to have clinical significance; * Subjects who test positive for any of the hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (Anti HCV), human immunodeficiency virus antibody (Anti HIV), and Treponema pallidum antibody (Anti TP); * Those who have undergone surgery within 4 weeks before screening or plan to undergo surgery during the study period; * Received investigational drugs or participated in clinical trials within 3 months prior to screening; * Received immunoglobulin or blood products within 30 days before randomization; * Donated blood (\> 300 mL) or experienced significant blood loss (\> 400 mL) within 3 months prior to screening; * Subjects with a history of needle sickness, blood sickness, or potential difficult in collecting blood; * History of allergic reactions to other therapeutic monoclonal antibodies or biological agents, or history of allergies to multiple drugs or foods, especially to ingredients similar to the study drug; * Smoking more than 5 cigarettes per day or using an equivalent amount of nicotine or nicotine containing products within 3 months before randomization, or failing to stop using any tobacco products during the trial period; * Those who have been drinking excessively for a long time or have consumed more than 14 units of alcohol per week within 3 months before screening, or cannot abstain from alcohol during the trial period, or have tested positive for alcohol breath test; * Subjects with a history of drug abuse, or positive urine drug screening; * Received any commercially available or investigational biological agents within 4 months before randomization or within 5 half-lives of drugs (whichever is longer); * Within 4 weeks before randomization, received any systemic prescription drugs, over-the-counter drugs, herbs, any vitamin products, and health products, or any topical drugs of the above forms at the injection site of this study; * From the screening period to the study medication, acute diseases or concomitant medication occured. * Any medical history that may affect drug absorption, distribution, metabolism, and excretion. * Any situation that the investigator believes will pose a safety risk to the subject during the study or may interfere with the implementation of this study, or the investigator believes that the subject may not be able to complete this study or may not be able to comply with the requirements of this study. * QT interval \> 450 milliseconds, or electrocardiogram is not suitable for Concentration-QT measurement (according to the judgment of the investigator). * History of risk factors for torsade de pointe ventricular tachycardia. Subject with a family history of long QT syndrome or Brugada syndrome will also be excluded. * Heart rate ≤ 45 bpm. * History of renal or liver dysfunction. * History or condition of cardiovascular disease.

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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.

Contacts and locations

Locations

  • The first hospital of Jilin University

    Changchun, Jilin, 130061, China

More trials for these conditions

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