Assessing how NEX-22A affects patients with type 2 diabetes

An Open, Single Ascending Dose, Phase 1 Study to Assess the Pharmacokinetics, Safety, and Tolerability of NEX-22A, a Subcutaneous Prolonged-release Injection, in Male and Female Participants With Type 2 Diabetes

This study is testing a new long-acting injection for people with type 2 diabetes to see how the body processes the medication and to check if it's safe.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Nanexa AB (industry)
• Locations: 1 site (Neuss)
• Trial ID: NCT06439056 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the pharmacokinetics of NEX-22A, a long-acting injectable formulation of liraglutide, in individuals diagnosed with type 2 diabetes. It is a single-center, open-label study that will enroll participants in three sequential cohorts, each receiving a single dose of the medication. Prior to advancing to the next dose cohort, safety, tolerability, and pharmacokinetic data will be reviewed by a dose escalation committee. Blood samples will be collected over a 36-day period to analyze the drug's pharmacokinetics.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with type 2 diabetes who have been on a stable dose of metformin for at least three months.

Not a fit: Patients with known hypersensitivity to liraglutide or those who have participated in this trial previously will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of type 2 diabetes through a more effective long-acting treatment option.

How similar studies have performed: Other studies involving long-acting formulations of GLP-1 receptor agonists have shown promise, indicating that this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Neuss

• Profil — Neuss, Germany (RECRUITING)

Study contacts

• Principal investigator: Grit Andersen, MD — Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss
• Study coordinator: David Westberg CEO

Conditions: Type 2 Diabetes, Type 2 diabetes, PK study, Long acting injectable, Liraglutid, GLP-1