Experimental diabetes drug AP026 tested in early trial – but study halted
NCT ID NCT06143423
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 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: * 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.
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.
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.
- 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?