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New Long-Acting diabetes shot shows promise in first human test

NCT ID NCT06439056

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tested a single injection of NEX-22A, a long-acting version of the diabetes drug liraglutide, in 12 adults with type 2 diabetes. The main goal was to see how the drug moves through the body and if it is safe. Participants were on stable metformin therapy and received one dose. Results will help decide if further testing is warranted.

What this could mean

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

Active substance
NEX-22A (a long-acting form of liraglutide)
What this could lead to
If successful, this could lead to a once-weekly or less frequent injection for managing type 2 diabetes, improving convenience for patients.
What could go wrong
This is a very early Phase 1 study with only 12 participants, so it is too small to prove effectiveness or safety. The drug may not work as hoped or could cause unexpected side effects.

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

12 people

The number who actually took part.

Started

May 2024

Finished

Jul 2025

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 65 years

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. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject. 2. Male or female subject with type 2 diabetes mellitus. 3. Metformin therapy without change in dose for the last 3 months. 4. Age between 18 and 65 years, both inclusive. 5. Body Mass Index (BMI) between 18.5 and 35.0 kg/m\^2, both inclusive. 6. HbA1c \> 6.5% and \<= 9.0%. 7. Diabetes duration of at least 1 year. Exclusion Criteria: 1. Known or suspected hypersensitivity to the IMP or any of the excipients or to any component of the IMP formulation. 2. Previous participation in this trial. Participation is defined as being dosed. 3. Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before enrolment in this trial. 4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 5. Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator. 6. Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data. 7. Signs of acute illness as judged by the investigator. 8. Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the investigator. 9. Subjects with dermatological conditions, tattoos or large scars on the abdomen that would limit the evaluation of local tolerability, as judged by the investigator. 10. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis at screening as judged by the investigator. 11. Systolic blood pressure \< 90 mmHg or \>160 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at screening (one repeat test will be acceptable in case of suspected white-coat hypertension). 12. Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute. 13. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the investigator. 14. Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1.5 years) ophthalmologic examination. 15. Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator. 16. Former or current use of liraglutide or any other GLP-1 receptor agonists (exenatide, semaglutide) except for the use in clinical trials. 17. Current use of any insulin or sulfonylureas. 18. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average. 19. A positive result in the alcohol and/or urine drug screen at the screening visit. 20. Smoking more than 5 cigarettes or the equivalent per day. 21. Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period. 22. Tested positive for hepatitis Bs antigen. 23. Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative). 24. Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen. 25. Any medication (prescription and non-prescription drugs) within 14 days before IMP administration and/or anticoagulant therapy. 26. Blood donation or blood loss of more than 500 mL within the last 3 months. 27. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 28. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. Women of childbearing potential. 30. Trial site personnel directly affiliated with this trial and their immediate families (spouse, biological or legal guardian, child, or sibling). 31. The investigator considers a subject as unsuitable for inclusion in the trial for any other reason. Explanatory note on Exclusion Criterion 25: Exceptions are stable doses of metformin, SGLT2-blockers, low dose aspirin, antihypertensives, statins, thyroid hormones or occasional use of paracetamol or ibuprofen, and ,if female, with the exception of menopausal hormone replacement therapy. Explanatory note on Exclusion Criterion 29: A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

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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

  • Profil

    Neuss, 41460, Germany

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